Pilot Study in Multi-Coil Repetitive Transcranial Magnetic Stimulation (rTMS) for Treatment Resistant Depression

Study Overview
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Brief Summary
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The purpose of this study is to assess the efficacy of a Deep Shaped-Field repetitive transcranial magnetic stimulation (DSF-rTMS) system in the treatment of depression.

Official Title
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Determining Effectiveness of Multi-Coil rTMS for Patients With Major Depressive Disorder: A Pilot Study

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Device: Cervel Neurotech Deep Shaped-Field repetitive transcranial magnetic stimulator (DSF-rTMS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Major depressive disorder (MDD) Mild to moderate level of resistance or intolerance to antidepressant treatment in the current episode. Will not become pregnant during study. Exclusion Criteria: Seizure disorder. History of brain injury or active CNS disease. Metal implants on or in brain, spinal cord, ear, eye or heart. Current use of proconvulsant medications (e.g., bupropion). Other significant psychiatric disorder. Substance use disorder (not including caffeine or nicotine). 7 or more failed treatment attempts for depression in one's lifetime. Have failed to clinically remit to an adequate trial of ECT or TMS.

Ages Eligible for Study
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Minimum Age: 18 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Coil Configuration A<br>Cervel Neurotech Deep Shaped-Field repetitive transcranial magnetic stimulator (DSF-rTMS) | Device: Cervel Neurotech Deep Shaped-Field repetitive transcranial magnetic stimulator (DSF-rTMS)<br>* The Cervel Neurotech Deep Shaped-Field repetitive transcranial magnetic stimulator is an investigational rTMS device<br>|
| Experimental: Coil Configuration B<br>Cervel Neurotech Deep Shaped-Field repetitive transcranial magnetic stimulator (DSF-rTMS) | Device: Cervel Neurotech Deep Shaped-Field repetitive transcranial magnetic stimulator (DSF-rTMS)<br>* The Cervel Neurotech Deep Shaped-Field repetitive transcranial magnetic stimulator is an investigational rTMS device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remission from depression | Changes in Hamilton Rating Scale from Depression (HRSD) measured after each block of 5 treatment sessions, 2 weeks post and 4 weeks post | baseline through 4 weeks post | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of rTMS | Determined by presence and absence of adverse events recorded daily | baseline through 4 weeks post | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, MDD, Transcranial Magnetic Stimulation, Depressive Disorder, TMS