| Primary | Primary Efficacy Endpoint: Difference in the Postural Tremor Score of the Target Limb Between Stimulation On and Stimulation Off, As Assessed by the Blind Reviewer | The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Mean | Standard Deviation | units on a scale | | Day 180 | | | | ID | Title | Description |
|---|
| OG000 | Stimulation | ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus |
| | | Title | Denominators | Categories |
|---|
| Stimulation Off | | | | Stimulation On | | | | Mean Difference | | |
| |
| Primary | Primary Safety Endpoint: Percentage of Participants With Device-related or Procedure Related Adverse Events | Percentage of device-related or procedure related adverse events will be assessed within 6 months following the initial unilateral implant. All such adverse events will be counted for 180 days following surgery or until the day of the second implant, which ever comes first. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Number | | percentage of participants | | Within 180 days following the initial implant | | | | ID | Title | Description |
|---|
| OG000 | Stimulation | ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus |
| |
| Secondary | Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Target Limb Severity Score, As Assessed by the Site Physician | The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Mean | Standard Deviation | score on a scale | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Stimulation | ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus |
| |
| Secondary | Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Target Limb Severity Score, As Assessed by the Site Physician | The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Mean | Standard Deviation | score on a scale | | Day 90 | | | | ID | Title | Description |
|---|
| OG000 | Stimulation | ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus |
| |
| Secondary | Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Target Limb Severity Score, As Assessed by the Site Physician | The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Mean | Standard Deviation | score on a scale | | Day 180 | | | | ID | Title | Description |
|---|
| OG000 | Stimulation | ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus |
| |
| Secondary | Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Target Limb Severity Score, As Assessed by the Site Physician | The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Mean | Standard Deviation | score on a scale | | Day 365 | | | | ID | Title | Description |
|---|
| OG000 | Stimulation | ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus |
| |
| Secondary | Clinical Rating Scale for Tremor (CRST) Evaluation- Target Limb Responder Analysis, As Assessed by the Site Physician | The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms. During responder analysis, a 2-point reduction in kinetic tremor or postural tremor between stimulation Off and stimulation On show an improvement in activities of daily living was considered a response, was also performed using the site physician's ratings. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Count of Participants | | Participants | | Day 90 | | | | ID | Title | Description |
|---|
| OG000 | Stimulation | ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus |
| |
| Secondary | Clinical Rating Scale for Tremor (CRST) Evaluation- Target Limb Responder Analysis, As Assessed by the Site Physician | The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms. During responder analysis, a 2-point reduction in kinetic tremor or postural tremor between stimulation Off and stimulation On show an improvement in activities of daily living was considered a response, was also performed using the site physician's ratings. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Count of Participants | | Participants | | Day 180 | | | | ID | Title | Description |
|---|
| OG000 | Stimulation | ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus |
| |
| Secondary | Clinical Rating Scale for Tremor (CRST) Evaluation- Target Limb Responder Analysis, As Assessed by the Site Physician | The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms. During responder analysis, a 2-point reduction in kinetic tremor or postural tremor between stimulation Off and stimulation On show an improvement in activities of daily living was considered a response, was also performed using the site physician's ratings. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Count of Participants | | Participants | | Day 365 | | | | ID | Title | Description |
|---|
| OG000 | Stimulation | ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus |
| |
| Secondary | Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Handwriting for Target Side Severity Score, As Assessed by the Site Physician | The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms. The site physician will evaluate the patient's handwriting according to the CRST (scale 0-4). | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Mean | Standard Deviation | score on a scale | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Stimulation | ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus |
| |
| Secondary | Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Handwriting for Target Side Severity Score, As Assessed by the Site Physician | The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms. The site physician will evaluate the patient's handwriting according to the CRST (scale 0-4). | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Mean | Standard Deviation | score on a scale | | Day 90 | | | | ID | Title | Description |
|---|
| OG000 | Stimulation | ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus |
| |
| Secondary | Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Handwriting for Target Side Severity Score, As Assessed by the Site Physician | The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms. The site physician will evaluate the patient's handwriting according to the CRST (scale 0-4). | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Mean | Standard Deviation | score on a scale | | Day 180 | | | | ID | Title | Description |
|---|
| OG000 | Stimulation | ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in theVIM nucleus of the thalamus |
| |
| Secondary | Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Handwriting for Target Side Severity Score, As Assessed by the Site Physician | The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms. The site physician will evaluate the patient's handwriting according to the CRST (scale 0-4). | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Mean | Standard Deviation | score on a scale | | Day 365 | | | | ID | Title | Description |
|---|
| OG000 | Stimulation | ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus |
| |
| Secondary | Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Handwriting for Target Side Severity Score, As Assessed by the Blind Reviewer | The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms. The blind reviewer will evaluate the patient's handwriting according to the CRST (scale 0-4). | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Mean | Standard Deviation | score on a scale | | Day 180 | | | | ID | Title | Description |
|---|
| OG000 | Stimulation | ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus |
| |
| Secondary | Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Pouring From Target Side Severity Scores, As Assessed by the Site Physician | The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms. The site physician will evaluate the patient's pouring ability according to the CRST | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Mean | Standard Deviation | score on a scale | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Stimulation | ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus |
| |
| Secondary | Clinical Rating Scale for Tremor (CRST) Evaluation-Mean Pouring From Target Side Severity Scores, As Assessed by the Site Physician | The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms. The site physician will evaluate the patient's pouring ability according to the CRST | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Mean | Standard Deviation | score on a scale | | Day 90 | | | | ID | Title | Description |
|---|
| OG000 | Stimulation | ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus |
| |
| Secondary | Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Pouring From Target Side Severity Scores, As Assessed by the Site Physician | The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms. The site physician will evaluate the patient's pouring ability according to the CRST | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Mean | Standard Deviation | score on a scale | | Day 180 | | | | ID | Title | Description |
|---|
| OG000 | Stimulation | ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus |
| |
| Secondary | Clinical Rating Scale for Tremor (CRST) Evaluation-Mean Pouring From Target Side Severity Scores, As Assessed by the Site Physician | The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms. The site physician will evaluate the patient's pouring ability according to the CRST | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Mean | Standard Deviation | score on a scale | | Day 365 | | | | ID | Title | Description |
|---|
| OG000 | Stimulation | ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus |
| |
| Secondary | Clinical Rating Scale for Tremor (CRST) Evaluation- Pouring Ability From Target Side Severity Scores, As Assessed by the Blind Reviewer | The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms. The blind reviewer will evaluate the patient's pouring ability according to the CRST | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Mean | Standard Deviation | score on a scale | | Day 180 | | | | ID | Title | Description |
|---|
| OG000 | Stimulation | ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus |
| |
| Secondary | Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Total Motor Score, As Assessed by the Site Physician | The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms. The motor score adds together all responses to the tremor assessment for questions 1-9 of the CRST (whether or not the specific side is being treated). | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Mean | Standard Deviation | score on a scale | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Stimulation | ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus |
| |
| Secondary | Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Total Motor Score, As Assessed by the Site Physician | The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms. The motor score adds together all responses to the tremor assessment for questions 1-9 of the CRST (whether or not the specific side is being treated). | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Mean | Standard Deviation | score on a scale | | Day 90 | | | | ID | Title | Description |
|---|
| OG000 | Stimulation | ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus |
| |
| Secondary | Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Total Motor Score, As Assessed by the Site Physician | The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms. The motor score adds together all responses to the tremor assessment for questions 1-9 of the CRST (whether or not the specific side is being treated). | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Mean | Standard Deviation | score on a scale | | Day 180 | | | | ID | Title | Description |
|---|
| OG000 | Stimulation | ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus |
| |
| Secondary | Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Total Motor Score, As Assessed by the Site Physician | The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms. The motor score adds together all responses to the tremor assessment for questions 1-9 of the CRST (whether or not the specific side is being treated). | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Mean | Standard Deviation | score on a scale | | Day 365 | | | | ID | Title | Description |
|---|
| OG000 | Stimulation | ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus |
| |
| Secondary | Clinical Rating Scale for Tremor (CRST) Evaluation- Activity of Daily Living Score, As Assessed by the Site Physician | The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms. The activity of daily living score adds together all responses to questions 15-21 of the CRST. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Mean | Standard Deviation | score on a scale | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Stimulation | ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus |
| |
| Secondary | Clinical Rating Scale for Tremor (CRST) Evaluation- Activity of Daily Living Score, As Assessed by the Site Physician | The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms. The activity of daily living score adds together all responses to questions 15-21 of the CRST. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Mean | Standard Deviation | score on a scale | | Day 90 | | | | ID | Title | Description |
|---|
| OG000 | Stimulation | ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus |
| |
| Secondary | Clinical Rating Scale for Tremor (CRST) Evaluation- Activity of Daily Living Score, As Assessed by the Site Physician | The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms. The activity of daily living score adds together all responses to questions 15-21 of the CRST. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Mean | Standard Deviation | score on a scale | | Day 180 | | | | ID | Title | Description |
|---|
| OG000 | Stimulation | ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus |
| |
| Secondary | Clinical Rating Scale for Tremor (CRST) Evaluation- Activity of Daily Living Score, As Assessed by the Site Physician | The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms. The activity of daily living score adds together all responses to questions 15-21 of the CRST. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Mean | Standard Deviation | score on a scale | | Day 365 | | | | ID | Title | Description |
|---|
| OG000 | Stimulation | ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus |
| |
| Secondary | Clinical Rating Scale for Tremor (CRST) Evaluation-Bilateral Stimulation, As Assessed by the Site Physician | The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms. For those patients that had bilateral stimulation, the site physician will evaluate the patient's non-target side after 180 days of bilateral stimulation. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Mean | Standard Deviation | score on a scale | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Stimulation | ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus |
| |
| Secondary | Clinical Rating Scale for Tremor (CRST) Evaluation-Bilateral Stimulation, As Assessed by the Site Physician | The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms. For those patients that had bilateral stimulation, the site physician will evaluate the patient's non-target side after 180 days of bilateral stimulation. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Mean | Standard Deviation | score on a scale | | Following 180 days of stimulation | | | | ID | Title | Description |
|---|
| OG000 | Stimulation | ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus |
| |
| Secondary | Clinical Rating Scale for Tremor (CRST) Evaluation-Non-Target Limb Severity Scores, As Assessed by the Site Physician | The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms. For those patients that had bilateral stimulation, the site physician will evaluate the patient's non-target side after 180 days with only the second side system On | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Mean | Standard Deviation | score on a scale | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Stimulation | ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus |
| |
| Secondary | Clinical Rating Scale for Tremor (CRST) Evaluation-Non-Target Limb Severity Scores, As Assessed by the Site Physician | The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms. For those patients that had bilateral stimulation, the site physician will evaluate the patient's non-target side after 180 days with only the second side system On | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Mean | Standard Deviation | score on a scale | | Following 180 days of stimulation | | | | ID | Title | Description |
|---|
| OG000 | Stimulation | ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus |
| |
| Secondary | Quality of Life in Essential Tremor (QUEST): Overall Summary Index | The QUEST questionnaire consists of 30 items, which are rated from 0 to 4, corresponding to the frequency (from never to always). Those 30 items assess how tremor impacts a function or how it can be associated with feelings or attitudes. The 30 items contribute to five sub scales (number of items contributing to each scale in parentheses): Physical/ADL (9), Psychosocial (9), Communication (3), Hobbies/Leisure (3), and Work/Finances (6). The score on each sub scale is expressed as a percentage of the total score possible, with a higher score indicating greater dissatisfaction with that domain of QOL. As the scores were expressed as percentages, if a question was unanswered it was excluded and percentages were calculated based on the remaining answers. A total or quest summary index (QSI) was computed by calculating the mean of the five scales. Maximal score of 100 indicates worse quality of life, while minimal score 0 corresponds to best quality of life. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Mean | Standard Deviation | score on a scale | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Stimulation | ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus |
| |
| Secondary | Change From Baseline for Quality of Life in Essential Tremor (QUEST): Overall Summary Index | The QUEST questionnaire consists of 30 items, which are rated from 0 to 4, corresponding to the frequency (from never to always). Those 30 items assess how tremor impacts a function or how it can be associated with feelings or attitudes. The 30 items contribute to five sub scales (number of items contributing to each scale in parentheses): Physical/ADL (9), Psychosocial (9), Communication (3), Hobbies/Leisure (3), and Work/Finances (6). The score on each sub scale is expressed as a percentage of the total score possible, with a higher score indicating greater dissatisfaction with that domain of QOL. As the scores were expressed as percentages, if a question was unanswered it was excluded and percentages were calculated based on the remaining answers. A total or quest summary index (QSI) was computed by calculating the mean of the five scales. Maximal score of 100 indicates worse quality of life, while minimal score 0 corresponds to best quality of life. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Mean | Standard Deviation | score on a scale | | Day 90 | | | | ID | Title | Description |
|---|
| OG000 | Stimulation | ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus |
| |
| Secondary | Change From Baseline for Quality of Life in Essential Tremor (QUEST): Overall Summary Index | The QUEST questionnaire consists of 30 items, which are rated from 0 to 4, corresponding to the frequency (from never to always). Those 30 items assess how tremor impacts a function or how it can be associated with feelings or attitudes. The 30 items contribute to five sub scales (number of items contributing to each scale in parentheses): Physical/ADL (9), Psychosocial (9), Communication (3), Hobbies/Leisure (3), and Work/Finances (6). The score on each sub scale is expressed as a percentage of the total score possible, with a higher score indicating greater dissatisfaction with that domain of QOL. As the scores were expressed as percentages, if a question was unanswered it was excluded and percentages were calculated based on the remaining answers. A total or quest summary index (QSI) was computed by calculating the mean of the five scales. Maximal score of 100 indicates worse quality of life, while minimal score 0 corresponds to best quality of life. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Mean | Standard Deviation | score on a scale | | Day 180 | | | | ID | Title | Description |
|---|
| OG000 | Stimulation | ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus |
| |
| Secondary | Change From Baseline for Quality of Life in Essential Tremor (QUEST): Overall Summary Index | The QUEST questionnaire consists of 30 items, which are rated from 0 to 4, corresponding to the frequency (from never to always). Those 30 items assess how tremor impacts a function or how it can be associated with feelings or attitudes. The 30 items contribute to five sub scales (number of items contributing to each scale in parentheses): Physical/ADL (9), Psychosocial (9), Communication (3), Hobbies/Leisure (3), and Work/Finances (6). The score on each sub scale is expressed as a percentage of the total score possible, with a higher score indicating greater dissatisfaction with that domain of QOL. As the scores were expressed as percentages, if a question was unanswered it was excluded and percentages were calculated based on the remaining answers. A total or quest summary index (QSI) was computed by calculating the mean of the five scales. Maximal score of 100 indicates worse quality of life, while minimal score 0 corresponds to best quality of life. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Mean | Standard Deviation | score on a scale | | Day 365 | | | | ID | Title | Description |
|---|
| OG000 | Stimulation | ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus |
| |
| Secondary | SF36 Components and Individual Domains | The SF-36 questionnaire is a measure of health status with 36 items across 8 domains. The eight domains are separated into two summary scores of four domains, the physical component summary (PCS) and mental component summary (MCS). The SF-36 score is transformed into a scale of 0-100, with 100 indicating no disability. PCS and MCS are scaled in comparison to population norms to reflect a mean of 50 and standard deviation of 10 for the general population of the United States. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Mean | Standard Deviation | score on a scale | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Stimulation | ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus |
| |
| Secondary | SF36 Components and Individual Domains | The SF-36 questionnaire is a measure of health status with 36 items across 8 domains. The eight domains are separated into two summary scores of four domains, the physical component summary (PCS) and mental component summary (MCS). The SF-36 score is transformed into a scale of 0-100, with 100 indicating no disability. PCS and MCS are scaled in comparison to population norms to reflect a mean of 50 and standard deviation of 10 for the general population of the United States. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Mean | Standard Deviation | score on a scale | | Day 90 | | | | ID | Title | Description |
|---|
| OG000 | Stimulation | ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus |
| |
| Secondary | SF36 Components and Individual Domains | The SF-36 questionnaire is a measure of health status with 36 items across 8 domains. The eight domains are separated into two summary scores of four domains, the physical component summary (PCS) and mental component summary (MCS). The SF-36 score is transformed into a scale of 0-100, with 100 indicating no disability. PCS and MCS are scaled in comparison to population norms to reflect a mean of 50 and standard deviation of 10 for the general population of the United States. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Mean | Standard Deviation | score on a scale | | Day 180 | | | | ID | Title | Description |
|---|
| OG000 | Stimulation | ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus |
| |
| Secondary | SF36 Components and Individual Domains | The SF-36 questionnaire is a measure of health status with 36 items across 8 domains. The eight domains are separated into two summary scores of four domains, the physical component summary (PCS) and mental component summary (MCS). The SF-36 score is transformed into a scale of 0-100, with 100 indicating no disability. PCS and MCS are scaled in comparison to population norms to reflect a mean of 50 and standard deviation of 10 for the general population of the United States. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Mean | Standard Deviation | score on a scale | | Day 365 | | | | ID | Title | Description |
|---|
| OG000 | Stimulation | ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus |
| |
| Secondary | Global Assessment Scores by Examiner | Global outcome measures are a self-rated questionnaire that measures a global assessment of the patient quality of life and the examiner's interpretation of the patient's quality of life. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Count of Participants | | Participants | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Stimulation | ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus |
| |
| Secondary | Global Assessment Scores by Examiner | Global outcome measures are a self-rated questionnaire that measures a global assessment of the patient quality of life and the examiner's interpretation of the patient's quality of life. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Count of Participants | | Participants | | Day 90 | | | | ID | Title | Description |
|---|
| OG000 | Stimulation | ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus |
| |
| Secondary | Global Assessment Scores by Examiner | Global outcome measures are a self-rated questionnaire that measures a global assessment of the patient quality of life and the examiner's interpretation of the patient's quality of life. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Count of Participants | | Participants | | Day 180 | | | | ID | Title | Description |
|---|
| OG000 | Stimulation | ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus |
| |
| Secondary | Global Assessment Scores by Examiner | Global outcome measures are a self-rated questionnaire that measures a global assessment of the patient quality of life and the examiner's interpretation of the patient's quality of life. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Count of Participants | | Participants | | Day 365 | | | | ID | Title | Description |
|---|
| OG000 | Stimulation | ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus |
| |
| Secondary | Global Assessment by Caregiver | Global outcome measures are a self-rated questionnaire that measures a global assessment of the patient quality of life and the caregiver's interpretation of the patient's quality of life | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Count of Participants | | Participants | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Stimulation | ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus |
| |
| Secondary | Global Assessment by Caregiver | Global outcome measures are a self-rated questionnaire that measures a global assessment of the patient quality of life and the caregiver's interpretation of the patient's quality of life | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Count of Participants | | Participants | | Day 90 | | | | ID | Title | Description |
|---|
| OG000 | Stimulation | ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus |
| |
| Secondary | Global Assessment by Caregiver | Global outcome measures are a self-rated questionnaire that measures a global assessment of the patient quality of life and the caregiver's interpretation of the patient's quality of life | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Count of Participants | | Participants | | Day 180 | | | | ID | Title | Description |
|---|
| OG000 | Stimulation | ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus |
| |
| Secondary | Global Assessment by Caregiver | Global outcome measures are a self-rated questionnaire that measures a global assessment of the patient quality of life and the caregiver's interpretation of the patient's quality of life | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Count of Participants | | Participants | | Day 365 | | | | ID | Title | Description |
|---|
| OG000 | Stimulation | ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus |
| |
| Secondary | Global Assessment by Patient | Global outcome measures are a self-rated questionnaire in which patients assess their own global outcome at each visit | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Count of Participants | | Participants | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Stimulation | ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus |
| |
| Secondary | Global Assessment by Patient | Global outcome measures are a self-rated questionnaire in which patients assess their own global outcome at each visit | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Count of Participants | | Participants | | Day 90 | | | | ID | Title | Description |
|---|
| OG000 | Stimulation | ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus |
| |
| Secondary | Global Assessment by Patient | Global outcome measures are a self-rated questionnaire in which patients assess their own global outcome at each visit | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Count of Participants | | Participants | | Day 180 | | | | ID | Title | Description |
|---|
| OG000 | Stimulation | ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus |
| |
| Secondary | Global Assessment by Patient | Global outcome measures are a self-rated questionnaire in which patients assess their own global outcome at each visit | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Count of Participants | | Participants | | Day 365 | | | | ID | Title | Description |
|---|
| OG000 | Stimulation | ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus |
| |
| Secondary | Subjective Assessment by Patient Since Activation of System | Subjective assessment includes changes in their ET symptoms since the last visit indicated as marked improvement, moderate improvement, mild improvement, worsening, or no change. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Count of Participants | | Participants | | Day 90 | | | | ID | Title | Description |
|---|
| OG000 | Stimulation | ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus |
| |
| Secondary | Subjective Assessment by Patient Since Activation of System | Subjective assessment includes changes in their ET symptoms since the last visit indicated as marked improvement, moderate improvement, mild improvement, worsening, or no change. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Count of Participants | | Participants | | Day 180 | | | | ID | Title | Description |
|---|
| OG000 | Stimulation | ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus |
| |
| Secondary | Subjective Assessment by Patient Since Activation of System | Subjective assessment includes changes in their ET symptoms since the last visit indicated as marked improvement, moderate improvement, mild improvement, worsening, or no change. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Count of Participants | | Participants | | Day 365 | | | | ID | Title | Description |
|---|
| OG000 | Stimulation | ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus |
| |
| Secondary | Number of Participants With Satisfaction With the DBS System's Functioning and Ability to Control Symptoms | At each visit, patients will be asked about their satisfaction with the DBS system's functioning and ability to control symptoms | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Count of Participants | | Participants | | Day 90 | | | | ID | Title | Description |
|---|
| OG000 | Stimulation | ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus |
| |
| Secondary | Number of Participants With Satisfaction With the DBS System's Functioning and Ability to Control Symptoms | At each visit, patients will be asked about their satisfaction with the DBS system's functioning and ability to control symptoms | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Count of Participants | | Participants | | Day 180 | | | | ID | Title | Description |
|---|
| OG000 | Stimulation | ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus |
| |
| Secondary | Number of Participants With Satisfaction With the DBS System's Functioning and Ability to Control Symptoms | At each visit, patients will be asked about their satisfaction with the DBS system's functioning and ability to control symptoms | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Count of Participants | | Participants | | Day 365 | | | | ID | Title | Description |
|---|
| OG000 | Stimulation | ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus |
| |
| Secondary | Number of Participants Who Would Choose to Receive the DBS System Again | At each visit, patients will be asked if they would undergo the DBS procedure again | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Count of Participants | | Participants | | Day 90 | | | | ID | Title | Description |
|---|
| OG000 | Stimulation | ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus |
| |
| Secondary | Number of Participants Who Would Choose to Receive the DBS System Again | At each visit, patients will be asked if they would undergo the DBS procedure again | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Count of Participants | | Participants | | Day 180 | | | | ID | Title | Description |
|---|
| OG000 | Stimulation | ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus |
| |
| Secondary | Number of Participants Who Would Choose to Receive the DBS System Again | At each visit, patients will be asked if they would undergo the DBS procedure again | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Count of Participants | | Participants | | Day 365 | | | | ID | Title | Description |
|---|
| OG000 | Stimulation | ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus |
| |
| Secondary | Number of Participants Who Would Recommend the DBS System | At each visit, patients will be asked if they would recommend the DBS system to others | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Count of Participants | | Participants | | Day 90 | | | | ID | Title | Description |
|---|
| OG000 | Stimulation | ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus |
| |
| Secondary | Number of Participants Who Would Recommend the DBS System | At each visit, patients will be asked if they would recommend the DBS system to others | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Count of Participants | | Participants | | Day 180 | | | | ID | Title | Description |
|---|
| OG000 | Stimulation | ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus |
| |
| Secondary | Number of Participants Who Would Recommend the DBS System | At each visit, patients will be asked if they would recommend the DBS system to others | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Count of Participants | | Participants | | Day 365 | | | | ID | Title | Description |
|---|
| OG000 | Stimulation | ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus |
| |
| Secondary | Beck Depression Inventory II (BDI - II) Score for Depression Symptoms | The Beck Depression Inventory II is A clinical rating scale designed for detecting depression based on the Diagnostic and Statistical Manual of Mental Health Disorders-Fourth Edition (DSM-IV) criteria. This widely used instrument consists of 21 items to assess the intensity of depression in clinical and normal patients. Each item is a list of four statements arranged in increasing severity about a particular symptom of depression. The BDI II questionnaire contains 21 questions, each answer being scored on a scale value of 0 to 3. A score between 0-13 indicates minimal depression, 14-19 mild depression, 20-28 moderate depression and 29-63 severe depression. Total scores are obtained by computing the sum of each score. The scores range from 0 to 63, with higher score indicating greater severity of depressive symptoms. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Mean | Standard Deviation | score on a scale | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Stimulation | ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus |
| |
| Secondary | Change From Baseline in Beck Depression Inventory II (BDI - II) Score for Depression Symptoms | The Beck Depression Inventory II is A clinical rating scale designed for detecting depression based on the Diagnostic and Statistical Manual of Mental Health Disorders-Fourth Edition (DSM-IV) criteria. This widely used instrument consists of 21 items to assess the intensity of depression in clinical and normal patients. Each item is a list of four statements arranged in increasing severity about a particular symptom of depression. The BDI II questionnaire contains 21 questions, each answer being scored on a scale value of 0 to 3. A score between 0-13 indicates minimal depression, 14-19 mild depression, 20-28 moderate depression and 29-63 severe depression. Total scores are obtained by computing the sum of each score. The scores range from 0 to 63, with higher score indicating greater severity of depressive symptoms. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Mean | Standard Deviation | score on a scale | | Day 365 | | | | ID | Title | Description |
|---|
| OG000 | Stimulation | ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus |
| |
| Secondary | Mini Mental State Exam (MMSE) for Examination of Mental Status | The Mini-Mental State Examination (MMSE) is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. It examines functions including registration (repeating named prompts), attention and calculation, recall, language, ability to follow simple commands and orientation. Any score of 24 or more (out of 30) indicates a normal cognition. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Mean | Standard Deviation | score on a scale | | Baseline | | | | ID | Title | Description |
|---|
| OG000 | Stimulation | ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus |
| |
| Secondary | Change From Baseline in Mini Mental State Exam (MMSE) For Examination of Mental Status | The Mini-Mental State Examination (MMSE) is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. It examines functions including registration (repeating named prompts), attention and calculation, recall, language, ability to follow simple commands and orientation. Any score of 24 or more (out of 30) indicates a normal cognition. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | | Mean | Standard Deviation | score on a scale | | Day 365 | | | | ID | Title | Description |
|---|
| OG000 | Stimulation | ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus |
| |