Low Frequency TMS on DLPFC and OFC in OCD Patients

Study Overview
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Brief Summary
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This study aims to evaluate the therapeutic effect of low frequency rTMS over the right DLPFC, versus right OFC versus Sham group of obsessive-compulsive disorder (OCD) patients. Sixty patients will be recruited from the out-patient psychiatric clinic of a university hospital, and randomized into three equal groups. The 1st group will receive 10 sessions of low frequency rTMS targeting right DLPFC by means of a butterfly coil, 120% RMT, 1 Hz, 3 trains, each of 500 pulses with a 40 seconds inter-train interval allowing the coil to cool. The 2nd group will receive 10 sessions of low-frequency rTMS over the right orbitofrontal cortex (OFC), the international 10-20 EEG system will be used to position the coil over the right OFC, at the right frontopolar 2 (Fp2) electrode site, using the following parameters: 120% motor threshold, 1 Hz, 3 trains, each of 500 pulses with a 40 seconds inter-train interval allowing the coil to cool. The 3rd group will receive sham stimulations with the same pulse delivery as the other groups but with the coil placed perpendicular to the scalp. The resting motor threshold (RMT) and cortical silent period (CSP) at different intensities from 110 % to 150 % will be measured before and after the end of sessions. All assessments like (Y-BOCS), (HAM-A), Beck Depression Inventory, (CGI-S), (MoCA) will be performed before and after end of the sessions and 3 months later.

Detailed Description
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This study aims to evaluate the therapeutic effect of low frequency rTMS over the right DLPFC, versus right OFC versus Sham group of OCD patients. Sixty patients will be recruited from the out-patient psychiatric clinic of a university hospital, the patients will be randomized into three groups (20 patients for each group) using closed envelopes. The first group (20 patients) will receive 10 sessions of low frequency rTMS targeting right DLPFC by means of a Butterfly coil, The DLPFC stimulation site was defined as the region 5 cm dorsolateral in the same sagittal plane as the optimal site for MT production in the first dorsal interosseous, using the following parameters: 120% RMT, 1 Hz, 3 trains, each of 500 pulses with a 40 seconds inter-train interval allowing the coil to cool. The second group (20 patients) will receive 10 sessions of low-frequency rTMS over the right orbitofrontal cortex (OFC) by means of a butterfly coil, the international 10-20 EEG system will be used to position the coil over the right OFC, at the right frontopolar 2 (Fp2) electrode site, using the following parameters: 120% motor threshold, 1 Hz, 3 trains, each of 500 pulses with a 40 seconds inter-train interval allowing the coil to cool. The third group (the sham condition) (20 patients) group will receive sham stimulations with the same pulse delivery as the other groups but with the coil placed perpendicular to the scalp. The resting motor threshold (RMT) and cortical silent period (CSP) at different intensities from 110 % to 150 % will be measured before and after the end of sessions. All assessments like (Y-BOCS), (HAM-A), Beck Depression Inventory, (CGI-S), (MoCA) will be performed before and after end of the sessions and 3 months later.

Official Title
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Comparative Study of the Therapeutic Effect of Low Frequency TMS on DLPFC and OFC in OCD Patients

Conditions
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Psychiatric Disorder

Intervention / Treatment
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* Procedure: Repetitive trans-magnetic stimulation (rTMS) on DLPFC
* Procedure: Repetitive trans-magnetic stimulation (rTMS) on OFC
* Procedure: Sham repetitive trans-magnetic stimulation (rTMS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: being 18 or over being assigned a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) or DSM-V diagnosis of OCD by the referring psychiatrist Exclusion Criteria: (1) presenting established cognitive or communication problems which makes it challenging to understand the questionnaires and take part in the therapeutic encounters (2) suffering from other severe psychiatric disorders, metabolic, or neurological disorders . (3) Patients with pacemaker, or metallic devices

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: First group<br>First group (20 patients) receive for 10 sessions of low frequency rTMS targeting right DLPFC by means of a Butterfly coil using the following parameters: 120% RMT, 1 Hz, 3 trains, each of 500 pulses with a 40 seconds inter-train interval allowing the coil to cool. | Procedure: Repetitive trans-magnetic stimulation (rTMS) on DLPFC<br>* Repetitive trans-magnetic stimulation (rTMS) on DLPFC<br>|
| Active Comparator: Second group<br>The second group (20 patients) will receive 10 sessions of low-frequency rTMS over the right orbitofrontal cortex (OFC) by means of a Butterfly coil using the following parameters: 120% motor threshold, 1 Hz, 3 trains, each of 500 pulses with a 40 seconds inter-train interval allowing the coil to cool. | Procedure: Repetitive trans-magnetic stimulation (rTMS) on OFC<br>* Repetitive trans-magnetic stimulation (rTMS) on OFC<br>|
| Sham Comparator: Third group<br>The third group (the sham condition) (20 patients) will receive sham stimulations of rTMS with the same pulse delivery as the other groups but with the coil placed perpendicular to the scalp. | Procedure: Sham repetitive trans-magnetic stimulation (rTMS)<br>* Sham repetitive trans-magnetic stimulation (rTMS)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Yale-Brown Obsessive Compulsive Scale (Y-BOCS) | Assessment of Obsessive Compulsive disorder using (Y-BOCS) | Three months | 
| Hamilton Anxiety Rating Scale (HAM-A) | Assessment of anxiety using Hamilton scale | Three months | 
| Beck Depression Inventory | Assessment of Depression using Beck depression inventory | Three months | 
| Clinical Global Impression-Severity scale (CGI-S) | Assessment of clinical severity using CGI-S | Three months | 
| Montreal Cognitive Assessment (MoCA) | Assessment of cognitive function using (MoCA) | Three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of cortical excitability parameters (RMT and CSP) | Measurment of changes of cortical excitability parameters (RMT and CSP) before and after sessions in the three groups. | Ten days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OCD, rTMS, right orbitofrontal cortex