Low Frequency TMS on DLPFC and OFC in OCD Patients

Not Applicable

Completed

• Conditions: Psychiatric Disorder
• Interventions: Procedure: Repetitive trans-magnetic stimulation (rTMS) on OFC; Procedure: Sham repetitive trans-magnetic stimulation (rTMS); Procedure: Repetitive trans-magnetic stimulation (rTMS) on DLPFC

• Registration Number: NCT03207633
• Lead Sponsor: Assiut University

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-06-24
• Study Start: 2017-07-01
• Study First Submitted QC: 2017-07-01
• Study First Posted: 2017-07-05
• Primary Completion: 2018-07-30
• Study Completion: 2018-07-30
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-12
• Last Update Posted: 2020-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Second group	Repetitive trans-magnetic stimulation (rTMS) on OFC	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.
Third group	Sham repetitive trans-magnetic stimulation (rTMS)	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.
First group	Repetitive trans-magnetic stimulation (rTMS) on DLPFC	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Changes of cortical excitability parameters (RMT and CSP)	Ten days	Measurment of changes of cortical excitability parameters (RMT and CSP) before and after sessions in the three groups.

Trial Locations

Locations (1)

Eman Khedr; 🇪🇬 Assiut, Egypt