Brainsway DTMS for Treatment of MDD Using iTBS

Study Overview
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Brief Summary
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The safety and effectiveness of the BrainsWay deep transcranial magnetic stimulation (DTMS) device for the intended use of Major Depressive Disorder (MDD) using the intermittent theta-burst (iTBS) stimulation protocol will be evaluated in a non-inferiority study, comparing the iTBS treatment with the FDA cleared, (510(k) No. K122288) Brainsway DTMS device to the High Frequency (HF) protocol using the same device.

Detailed Description
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The purpose of the study is to evaluate the safety and efficacy of Brainsway Deep TMS for the treatment of Major Depressive Disorder using the iTBS stimulation protocol, by comparing it to clinical data collected in the Brainsway randomized, controlled Multicenter study (CTP-001-00), using the HF DTMS stimulation protocol used in support of the Brainsway DTMS device 510(k) K122288. In the post-marketing study, patients will be treated with an intermittent theta burst (iTBS) protocol, using the same Brainsway DTMS device with the same H1-Coil. Furthermore, the treatment paradigm is the same, consisting of TMS sessions performed daily for 5 weeks (20 DTMS sessions). The iTBS stimulation protocol consists of bursts of 3 pulses at 50 Hz, 5 Hz bursts frequency, 2s on and 8s off, 600 pulses per session. The HF stimulation protocol was delivered at 18 Hz, 120% stimulation intensity of the resting MT, 55 trains of 2s duration, inter-train interval (ITI) of 20s, for 1980 pulses per session. The clinical study design includes multiple measurements of safety and effectiveness parameters. The primary outcome measure is the change from baseline in HDRS-21 scores at the 5 week visit (after 20 treatment sessions). The success criteria of the study is a non-inferiority margin of 3.0 points. The secondary efficacy endpoints of the study include evaluation of the response and remission rates, based on HDRS-21 scores, at the 5 week visit, change in CGI-S score from baseline to 6 weeks and response and remission rates based on CGI-S scores at the 6 week visit. Safety will be assessed at each treatment visit. Patients will be asked to report any adverse event since their previous visit.

Official Title
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Brainsway Deep TMS System for Treatment of Major Depressive Disorder (MDD) Using Intermittent Theta Burst Stimulation (iTBS) Protocol

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Device: Brainsway DTMS with intermittent Theta Burst Stimulation (iTBS)
* Device: Brainsway DTMS with High Frequency (HF) Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Outpatients Diagnosis of Major Depression Disorder Exclusion Criteria: Other significant Axis I psychiatric disorder with greater impairment than MDD

Ages Eligible for Study
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Minimum Age: 18 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: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Brainsway Deep TMS with intermittent Theta Burst Stimulation (iTBS)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Brainsway DTMS with intermittent Theta Burst Stimulation (iTBS)<br>Brainsway DTMS with intermittent Theta Burst Stimulation (iTBS) | Device: Brainsway DTMS with intermittent Theta Burst Stimulation (iTBS)<br>* Brainsway DTMS with iTBS<br>|
| Active Comparator: Brainsway DTMS with High Frequency Stimulation (HF)<br>Brainsway DTMS with High Frequency Stimulation (HF) | Device: Brainsway DTMS with High Frequency (HF) Stimulation<br>* Brainsway DTMS with HF<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome measure was the change from baseline in HDRS-21 scores at the 5 week visit. | Hamilton Depression Rating Scale (HDRS-21 items), where minimum score is 0 and maximum score is 53, and where higher scores mean a worse outcome. The success criteria of the study was a non-inferiority margin of 3.0 points. | 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HDRS-21 Response and Remission rates | Evaluation of the response and remission rates based on HDRS-21 scores | 5 weeks | 
| Change in CGI-S score from baseline at the 6 week visit | Clinical Global Improvement - Severity Scale (CGI-S), where minimum score is 1 and maximum score is 7, and where higher scores mean a worse outcome. | 6 weeks | 
| CGI-S Response and Remission rates | Evaluation of the response and remission rates based on CGI-S scores | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intermittent Theta Burst Stimulation, iTBS, Depression