Study to Evaluate Treatment Effects Associated With the NeuroStar SoftStart Treatment Feature

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Prospective, Randomized, Single Blind, Crossover Study to Evaluate Treatment Effects Associated With the NeuroStar New Treatment Feature

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Device: repetitive Transcranial Magnetic Stimulation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Patients will be switched between different treatment arms and asked to complete questionnaires.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dash Protocol<br>Patients will be randomized after consent to receive standard Dash protocol | Device: repetitive Transcranial Magnetic Stimulation<br>* the administration of a series of magnetic stimuli to the brain for the purpose of altering brain function<br>|
| Active Comparator: Modified Dash protocol with the New feature enabled<br>Patients will be randomized after consent to receive modified Dash protocol with the New feature enabled | Device: repetitive Transcranial Magnetic Stimulation<br>* the administration of a series of magnetic stimuli to the brain for the purpose of altering brain function<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate comfort of TMS treatment | The difference in the change in Visual Analog Scale scores for Comfort after rTMS stimulation between treatments administered with the Dash protocol and with New feature enabled. Comfort will be evaluated as a change for all observations between groups, observations from Baseline to end of escalation phase, observations between groups during the crossover phase and observations within a patient between treatments in the cross-over phase. At minute 3:45, and at the end of the treatment session, the subject will be asked to complete a Visual Analog Scale (VAS), for Comfort/Pain. | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ability to reach prescribed treatment intensity | The ability to reach the prescribed treatment intensity, the time it takes to reach the prescribed intensity, maximum treatment intensity reached, subject treatment preference and discontinuations due to treatment discomfort between the two treatment protocols. Once TMS therapy begins, adjustments to lower the stimulation intensity can begin immediately, as needed, for subject tolerance. The 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 %MT achieved. The goal will be to reach and sustain the target MT established by the treating physician of 120%MT. Once the target MT has been achieved and sustained for a certain period of time recording and increases of %MT may be discontinued, but re-started at central intervals if %MT is subsequently reduced. | 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TMS, Major Depressive Disorder, NeuroStar TMS