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The purpose of this study is to evaluate the comfort of the NeuroStar® Advanced Therapy System regular prescribed TMS protocol versus a New Feature.
This is a 2 week study to evaluate the New Feature an exclusive feature available on the NeuroStar® Advanced Therapy System. This feature introduces a series of stepped pulses within each pulse train ramping up the pulse magnitude to the prescribed treatment level. Patients will be randomized after consent to receive either the standard Dash protocol or the modified Dash protocol with the New feature enabled. The subjects will be switched between treatment protocols and asked to complete comfort, and depression questionnaires.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dash protocol ramp first | Active Comparator | Patients will be randomized after consent to receive a standard Dash protocol ramp. After the ramping phase, participants will receive both active conditions in the order: modified protocol, dash, modified protocol, dash. Protocols will be delivered 24 hours apart. |
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| Modified Dash protocol ramp first | Active Comparator | Patients will be randomized after consent to receive a modified Dash protocol ramp. After the ramping phase, participants will receive both active conditions in the order: dash, modified protocol, dash, modified protocol. Protocols will be delivered 24 hours apart. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| repetitive Transcranial Magnetic Stimulation | Device | the administration of a series of magnetic stimuli to the brain for the purpose of altering brain function |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate Comfort of TMS Treatment | The average Visual Analog Scale scores for the two conditions Dash protocol and modified DASH. VAS - Visual Analog Scale range is 0-100 (0- no pain/discomfort; 100- extreme discomfort/worse pain) | 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Reach Prescribed Treatment Intensity | Th average time to reach the prescribed treatment intensity. Once TMS therapy begins, adjustments to the stimulation intensity can begin immediately, as needed, according to subject tolerance. The TMS treater will assess if the subject can tolerate escalating the treatment MT by 10% at different time points. At each interval and the end of treatment, the treater will record the current intensity (%MT) achieved. The goal will be to reach and sustain the target intensity established by the treating physician (120%MT). |
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Inclusion Criteria:
1. 22-70 years.
2. Subject qualifies to receive TMS Therapy with the NeuroStar Advanced Therapy System to treat Major Depressive Disorder (MDD) per current FDA-cleared treatment guidelines as evaluated by the treating physician.
3. Subject has MDD diagnosis according to applicable DSM-IV, DSM-IV-TR, DSM-V, ICD-9, or ICD-10 criteria.
4. Subject failed to respond to at least one prior anti-depressant medication. 5. Subject consented to receive TMS Therapy to treat MDD with his or her physician independent of potential participation in this clinical study.
6. Subject must agree not to take analgesic pain medication(s) within 8 hours prior to TMS therapy sessions.
7. Subject provides written consent to take part in the study.
Exclusion Criteria:
1. Subject satisfies any one or more of the contraindications for TMS Therapy per current treatment guidelines as determined by the PI.
2. Physician intends to treat the subject with an off-label TMS Therapy or indication.
3. Family history of seizures or epilepsy. 4. Subject has received prior TMS. 5. Subject is currently taking analgesic medication or substances which may affect their perception or sensation of pain.
6. Known or suspected pregnancy.
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| Name | Affiliation | Role |
|---|---|---|
| Steve A Erickson, BS | Neuronetics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TMS of South Tampa | Tampa | Florida | 33609 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Modified DASH First | Participants started with modified dash protocols first. |
| FG001 | DASH Treatment First | Participants started with DASH treatment first |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ramp up Phase (5 Days) |
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| Treatment Phase (4 Days) |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects | Patients will be randomized after consent to receive modified Dash protocol with the New feature enabled repetitive Transcranial Magnetic Stimulation: the administration of a series of magnetic stimuli to the brain for the purpose of altering brain function |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 | Evaluate Comfort of TMS Treatment | The average Visual Analog Scale scores for the two conditions Dash protocol and modified DASH. VAS - Visual Analog Scale range is 0-100 (0- no pain/discomfort; 100- extreme discomfort/worse pain) | VAS scores were collected for both standard and modified dash conditions for each participant. An average VAS score for each condition was calculated for each participant. | Posted | Mean | Standard Deviation | VAS score on a scale | 10 days |
|
up to 9 days for each subject. 1st day of treatment to last day of treatment
Standard adverse event definition
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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 | Dash Protocol | Patients will be randomized after consent to receive standard Dash protocol repetitive Transcranial Magnetic Stimulation: the administration of a series of magnetic stimuli to the brain for the purpose of altering brain function |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye Discomfort | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Neha Goyal | Neuronetics | 763-528-1599 | neha.goyal@neurostar.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 9, 2022 | Aug 28, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 16, 2023 | Aug 28, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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Patients will be switched between different treatment arms and asked to complete questionnaires.
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The study will be randomized to avoid any bias in treatment arm assignment. Subjects will be blinded to the actual treatment arm throughout the study to allow patient to provide an honest assessment of the treatment they are receiving daily. Subjects will not be informed of the treatment at the end of their study participation.
| 5 days |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Primary diagnosis | Primary Diagnosis of F33.2 Major Depressive Disorder | Count of Participants | Participants |
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| Secondary | Time to Reach Prescribed Treatment Intensity | Th average time to reach the prescribed treatment intensity. Once TMS therapy begins, adjustments to the stimulation intensity can begin immediately, as needed, according to subject tolerance. The TMS treater will assess if the subject can tolerate escalating the treatment MT by 10% at different time points. At each interval and the end of treatment, the treater will record the current intensity (%MT) achieved. The goal will be to reach and sustain the target intensity established by the treating physician (120%MT). | Average time in number of days to reach maximum treatment intensity (120% MT). During the ramp-up phase, this could take 1-5 days in both arm. | Posted | Mean | Standard Deviation | days | 5 days |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 4 |
| 40 |
| EG001 | Modified Dash Protocol With the New Feature Enabled | Patients will be randomized after consent to receive modified Dash protocol with the New feature enabled repetitive Transcranial Magnetic Stimulation: the administration of a series of magnetic stimuli to the brain for the purpose of altering brain function | 0 | 40 | 0 | 40 | 3 | 40 |
| Hand Movement | Musculoskeletal and connective tissue disorders | Systematic Assessment | During TMS, subject reported involuntary hand movement that was corrected by coil adjustment. |
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| Discomfort | Skin and subcutaneous tissue disorders | Systematic Assessment |
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