dTMS in Obsessive Compulsive Disorder

Study Overview
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Brief Summary
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High-frequency deep transcranial magnetic stimulation (dTMS) over the medial prefrontal cortex (mPFC) and the anterior cingulate cortex (ACC) with an H-coil has been approved by the Food and Drug Administration for use in treatment-resistant obsessive-compulsive disorder (OCD). However, there is not yet strong scientific evidence concerning the efficacy and safety of performing a similar procedure with a double-cone coil or in an accelerated manner. The aim of this study was evaluating the efficacy of dTMS over the medial prefrontal cortex (mPFC) and the anterior cingulate cortex (ACC) in an accelerated manner with double-cone coil.

Detailed Description
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The current study aimed to investigate the efficacy and safety of multiple deep stimulations per day with a double-cone coil to the mPFC and ACC in treatment-resistant patients with OCD. This study evaluated (I) the effectiveness of high-frequency stimulation of the mPFC and ACC with a double cone coil, and (II) the effectiveness of the application of this protocol in three weeks, not six weeks as approved by the FDA. The participants were randomized into two parallel groups in a double-blind manner. High frequency (20 Hz) dTMS was applied to the mPFC and ACC in one group and sham dTMS to the same regions in the other group, twice a day, for a total of 30 sessions. This application was for three weeks in total, excluding weekends.

Official Title
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Effectiveness of Deep Transcranial Magnetic Stimulation to Medial Prefrontal Cortex and Anterior Cingulate Cortex in Obsessive-Compulsive Disorder Patients

Conditions
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Obsessive-Compulsive Disorder

Intervention / Treatment
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* Device: deep TMS
* Device: Sham TMS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of obsessive-compulsive disorder Not having an adequate response to treatment despite using at least two selective serotonin reuptake inhibitors at a sufficient dose and duration for 12 weeks before the planned add-on treatment Aged 18-65 years Able to read and write Exclusion Criteria: Not providing consent to participate in the study Diagnosis of a psychiatric disorder, such as psychotic disorder, bipolar disorder, major depressive disorder [Hamilton Depression Rating Scale (HDRS) score above 17], mental retardation, alcohol-substance use disorder, and organic mental disorder (dementia, delirium, and head trauma, etc.) Diagnosis of an important medical or neurological disease (e.g., epilepsy); Mental retardation Illiteracy Having received electroconvulsive therapy (ECT) or TMS within the last six months; Having any prosthesis, such as an implant and pacemaker.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: dTMS group<br>dTMS on anterior cingulate cortex and medial prefrontal cortex. | Device: deep TMS<br>* Deep Transcranial magnetic stimulation on anterior Cingulate cortex and medial prefrontal cortex. 20 Hz.<br>|
| Sham Comparator: sham TMS<br>Sham TMS on anterior cingulate cortex and medial prefrontal cortex. | Device: Sham TMS<br>* Sham Transcranial magnetic stimulation on anterior Cingulate cortex and medial prefrontal cortex. 20 Hz.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Obsessive compulsive symptoms severity | Yale-Brown Obsessive-Compulsive Scale (Y-BOCS). The minimum and maximum values are 0-40, and higher scores mean a worse outcome. | pretreatment(0.weeks)-as soon as the work is completed (3 weeks) | 
| Dimensional obsessive compulsive symptom severity | Dimensional Obsessive-Compulsive Scale (DOCS). The minimum and maximum values are 0-80, and higher scores mean a worse outcome. | pretreatment(0.weeks)-as soon as the work is completed (3 weeks) | 
| Severity of side effects | Clinical Global Impression - The efficacy index. The minimum and maximum values are 1-4, and higher scores mean a worse outcome. | pretreatment(0.weeks)-as soon as the work is completed (3 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of Depression | Hamilton Depression Rating Scale. The minimum and maximum values are 0-52, and higher scores mean a worse outcome. | pretreatment(0.weeks)-as soon as the work is completed (3 weeks) | 
| Severity of anxiety | Hamilton Anxiety Rating Scale. The minimum and maximum values are 0-56, and higher scores mean a worse outcome. | pretreatment(0.weeks)-as soon as the work is completed (3 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obsessive compulsive disorder, Transcranial Magnetic Stimulation