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The objective of this clinical investigation is to characterize the clinical performance of Abbott's Clinician Programmer Electrode Screening Mode tool (InformityTM tool) in programming InfinityTM deep brain stimulation (DBS) systems for patients with Parkinson's disease (PD) or essential tremor (ET).
This is a prospective, non-randomized, single-arm, multi-center, post-market clinical investigation designed to evaluate Abbott's Informity tool for Infinity DBS systems.
This clinical investigation will be conducted at up to 5 centers in the United States.
Up to 40 patients were intended to enroll in the study. However the study was stopped after enrolling 8 subjects at 3 sites.
Subjects participating in this clinical investigation will be followed for 6 months. The expected duration of enrollment is 6 months. The total duration of the clinical investigation is expected to be 18 months. The primary and secondary endpoints will be evaluated when all subjects have completed their 6 month follow-up visits
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental | Clinician programmer electrode screening mode tool |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinician programmer electrode screening mode tool | Device | Provides a standardized workflow to guide clinicians or trained healthcare providers through the deep brain stimulation monopolar review screening process |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Therapeutic Window Size With Selected Contact at the Informity Programming Visit Compared to Baseline | Therapeutic window was defined as the electrical current at which the side effect appeared minus the electrical current at which complete therapeutic benefit was obtained. The reported value is the range of current between first side effect appearance and complete therapeutic benefit. The 'Selected contact' is the therapeutic window for the contact configuration selected for the patient's programming. The 'best contact' is the therapeutic window for the contact configuration that showed the widest therapeutic window during Informity testing. | At Day 21 compared to baseline |
| Change in Therapeutic Window Size With Best Contact at the Informity Programming Visit Compared to Baseline | Therapeutic window was defined as the electrical current at which the side effect appeared minus the electrical current at which complete therapeutic benefit was obtained. The reported value is the range of current between first side effect appearance and complete therapeutic benefit. The 'Selected contact' is the therapeutic window for the contact configuration selected for the patient's programming. The 'best contact' is the therapeutic window for the contact configuration that showed the widest therapeutic window during Informity testing. | At Day 21 compared to baseline |
| Change in Therapeutic Electrical Energy Delivered (TEED) With Selected Contact at the Informity Programming Visit Compared to Baseline | TEED measures the total energy delivered by the deep brain stimulation system, and is represented as delivery over a set, arbitrary period of time. TEED is determined by the programmed stimulation parameters and measured system impedance. The 'Selected contact' is the contact configuration selected for the patient's programming. The 'best contact' is the contact configuration with the lowest TEED during Informity testing. | At Day 21 compared to baseline |
| Change in Therapeutic Electrical Energy Delivered (TEED) With Best Contact at the Informity Programming Visit Compared to Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Motor Symptom Evaluation for ET Subjects- Change in Fahn Tolosa Marin Tremor Rating Scale (FTM-TRS) Scores at 3 Months | Change in Fahn-Tolosa-Marin tremor rating scale for ET subjects at 3-month follow-up visit compared to baseline. Fahn-Tolosa-Marin tremor rating scale scores are expressed as a percentage of the total score possible (range of 0% to 100%), and lower scores indicate less severe motor symptoms. |
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INCLUSION CRITERIA
Parkinson's disease patients:
Essential tremor patients:
EXCLUSION CRITERIA
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| Name | Affiliation | Role |
|---|---|---|
| Bradley White | Abbott | Study Chair |
| Binith Cheeran | Abbott Medical Devices Neuromodulation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Albany Medical Center | Albany | New York | 12208 | United States | ||
| The University of Texas Health Science at San Antonio |
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The study enrolled a total of 8 subjects at 3 investigation sites. Of which seven subjects were diagnosed with Essential Tremor and one subject with Parkinson's Disease. The first subject enrollment was on June 26, 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm | Clinician programmer electrode screening mode tool Clinician programmer electrode screening mode tool: Provides a standardized workflow to guide clinicians or trained healthcare providers through the deep brain stimulation monopolar review screening process |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm | Clinician programmer electrode screening mode tool Clinician programmer electrode screening mode tool: Provides a standardized workflow to guide clinicians or trained healthcare providers through the deep brain stimulation monopolar review screening process |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Therapeutic Window Size With Selected Contact at the Informity Programming Visit Compared to Baseline | Therapeutic window was defined as the electrical current at which the side effect appeared minus the electrical current at which complete therapeutic benefit was obtained. The reported value is the range of current between first side effect appearance and complete therapeutic benefit. The 'Selected contact' is the therapeutic window for the contact configuration selected for the patient's programming. The 'best contact' is the therapeutic window for the contact configuration that showed the widest therapeutic window during Informity testing. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Mean | Standard Deviation | milliampere (mA) | At Day 21 compared to baseline |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single Arm | Clinician programmer electrode screening mode tool Clinician programmer electrode screening mode tool: Provides a standardized workflow to guide clinicians or trained healthcare providers through the deep brain stimulation monopolar review screening process |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Spine fracture | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Persistent pain, tightness, or discomfort around the implanted parts | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
Subjects enrolled at the experienced centers in this study already had individually tailored therapy at the baseline visit.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Binith Cheeran | Abbott Medical Devices Neuromodulation | +15122864262 | binith.cheeran@abbott.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 8, 2020 | Apr 29, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020329 | Essential Tremor |
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D009069 | Movement Disorders |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020734 | Parkinsonian Disorders |
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Outcomes assessor will be masked to subjects' deep brain stimulation programming.
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|
TEED measures the total energy delivered by the deep brain stimulation system, and is represented as delivery over a set, arbitrary period of time. TEED is determined by the programmed stimulation parameters and measured system impedance. The 'Selected contact' is the contact configuration selected for the patient's programming. The 'best contact' is the contact configuration with the lowest TEED during Informity testing. |
| At Day 21 compared to baseline |
| At 3 months compared to baseline |
| Motor Symptom Evaluation for ET Subjects- Change in Fahn Tolosa Marin Tremor Rating Scale (FTM-TRS) Scores at 6 Months | Change in Fahn-Tolosa-Marin tremor rating scale for ET subjects at 6-month follow-up visit compared to baseline. Fahn-Tolosa-Marin tremor rating scale scores are expressed as a percentage of the total score possible (range of 0% to 100%), and lower scores indicate less severe motor symptoms. | At 6 months compared to baseline |
| Mean Quality of Life for Essential Tremor Subjects as Measured by the Quality of Life in Essential Tremor (QUEST) at Baseline | Mean quality of life will be measured by the QUEST for ET subjects at baseline. 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. Maximal score of 100 indicates worse quality of life, while minimal score 0 corresponds to best quality of life. | At baseline |
| Mean Quality of Life for Essential Tremor Subjects as Measured by the Quality of Life in Essential Tremor (QUEST) at 3 Months | Mean quality of life will be measured by the QUEST for ET subjects at 3 months follow-up visit. 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. Maximal score of 100 indicates worse quality of life, while minimal score 0 corresponds to best quality of life. | At 3 months |
| Mean Quality of Life for Essential Tremor Subjects as Measured by the Quality of Life in Essential Tremor (QUEST) at 6 Months | Mean quality of life will be measured by the QUEST for ET subjects at 6 months follow-up visit. 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. Maximal score of 100 indicates worse quality of life, while minimal score 0 corresponds to best quality of life. | At 6 months |
| Mean Duration of Programming | Duration of programming at the Informity programming visit compared to the most recent programming session prior to enrollment | At Day 21 |
| Change in Therapeutic Electrical Energy Delivered (TEED) at 3 Months | Change in TEED at the 3-month follow-up visit compared to baseline | At 3 months compared to baseline |
| Change in Therapeutic Electrical Energy Delivered (TEED) at 6 Months | Change in TEED at the 6-month follow-up visit compared to baseline | At 6 months compared to baseline |
| San Antonio |
| Texas |
| 78229 |
| United States |
| Inland Northwest Research | Spokane | Washington | 99202 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Essential Tremor | Count of Participants | Participants |
|
| Parkinson's Disease | Count of Participants | Participants |
|
| Years of essential tremor symptoms | Of the total 8 subjects enrolled, 7 subjects were diagnosed with Essential Tremor and 1 subject with Parkinson's Disease. | Mean | Standard Deviation | years |
|
| Years since initial diagnosis of essential tremor | Of the total 8 subjects enrolled, 7 subjects were diagnosed with Essential Tremor and 1 subject with Parkinson's Disease. | Mean | Standard Deviation | years |
|
|
|
| Primary | Change in Therapeutic Window Size With Best Contact at the Informity Programming Visit Compared to Baseline | Therapeutic window was defined as the electrical current at which the side effect appeared minus the electrical current at which complete therapeutic benefit was obtained. The reported value is the range of current between first side effect appearance and complete therapeutic benefit. The 'Selected contact' is the therapeutic window for the contact configuration selected for the patient's programming. The 'best contact' is the therapeutic window for the contact configuration that showed the widest therapeutic window during Informity testing. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Mean | Standard Deviation | milliampere (mA) | At Day 21 compared to baseline |
|
|
|
| Primary | Change in Therapeutic Electrical Energy Delivered (TEED) With Selected Contact at the Informity Programming Visit Compared to Baseline | TEED measures the total energy delivered by the deep brain stimulation system, and is represented as delivery over a set, arbitrary period of time. TEED is determined by the programmed stimulation parameters and measured system impedance. The 'Selected contact' is the contact configuration selected for the patient's programming. The 'best contact' is the contact configuration with the lowest TEED during Informity testing. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Mean | Standard Deviation | microjoule (μJ) | At Day 21 compared to baseline |
|
|
|
| Primary | Change in Therapeutic Electrical Energy Delivered (TEED) With Best Contact at the Informity Programming Visit Compared to Baseline | TEED measures the total energy delivered by the deep brain stimulation system, and is represented as delivery over a set, arbitrary period of time. TEED is determined by the programmed stimulation parameters and measured system impedance. The 'Selected contact' is the contact configuration selected for the patient's programming. The 'best contact' is the contact configuration with the lowest TEED during Informity testing. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Mean | Standard Deviation | microjoule (μJ) | At Day 21 compared to baseline |
|
|
|
| Secondary | Motor Symptom Evaluation for ET Subjects- Change in Fahn Tolosa Marin Tremor Rating Scale (FTM-TRS) Scores at 3 Months | Change in Fahn-Tolosa-Marin tremor rating scale for ET subjects at 3-month follow-up visit compared to baseline. Fahn-Tolosa-Marin tremor rating scale scores are expressed as a percentage of the total score possible (range of 0% to 100%), and lower scores indicate less severe motor symptoms. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Mean | Standard Deviation | score on a scale | At 3 months compared to baseline |
|
|
|
| Secondary | Motor Symptom Evaluation for ET Subjects- Change in Fahn Tolosa Marin Tremor Rating Scale (FTM-TRS) Scores at 6 Months | Change in Fahn-Tolosa-Marin tremor rating scale for ET subjects at 6-month follow-up visit compared to baseline. Fahn-Tolosa-Marin tremor rating scale scores are expressed as a percentage of the total score possible (range of 0% to 100%), and lower scores indicate less severe motor symptoms. | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Mean | Standard Deviation | score on a scale | At 6 months compared to baseline |
|
|
|
| Secondary | Mean Quality of Life for Essential Tremor Subjects as Measured by the Quality of Life in Essential Tremor (QUEST) at Baseline | Mean quality of life will be measured by the QUEST for ET subjects at baseline. 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. 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 | At baseline |
|
|
|
| Secondary | Mean Quality of Life for Essential Tremor Subjects as Measured by the Quality of Life in Essential Tremor (QUEST) at 3 Months | Mean quality of life will be measured by the QUEST for ET subjects at 3 months follow-up visit. 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. 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 | At 3 months |
|
|
|
| Secondary | Mean Quality of Life for Essential Tremor Subjects as Measured by the Quality of Life in Essential Tremor (QUEST) at 6 Months | Mean quality of life will be measured by the QUEST for ET subjects at 6 months follow-up visit. 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. 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 | At 6 months |
|
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| Secondary | Mean Duration of Programming | Duration of programming at the Informity programming visit compared to the most recent programming session prior to enrollment | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Mean | Standard Deviation | minutes | At Day 21 |
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| Secondary | Change in Therapeutic Electrical Energy Delivered (TEED) at 3 Months | Change in TEED at the 3-month follow-up visit compared to baseline | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Mean | Standard Deviation | milliampere (mA) | At 3 months compared to baseline |
|
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| Secondary | Change in Therapeutic Electrical Energy Delivered (TEED) at 6 Months | Change in TEED at the 6-month follow-up visit compared to baseline | The number of participants analyzed includes subjects who were available at that time of analysis | Posted | Mean | Standard Deviation | milliampere (mA) | At 6 months compared to baseline |
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| 0 |
| 8 |
| 2 |
| 8 |
| 1 |
| 8 |
| Extension malfunction | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
|
| Initial jolt, or tingling stimulation | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
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| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| Title | Measurements |
|---|---|
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| Physical |
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| Psychosocial |
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| Title | Measurements |
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| Physical |
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| Psychosocial |
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| Title | Measurements |
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| Physical |
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| Psychosocial |
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