Low Frequency TMS on DLPFC and OFC in OCD Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2018-07-30

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.

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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.

Conditions

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Psychiatric Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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First group

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.

Group Type ACTIVE_COMPARATOR

Repetitive trans-magnetic stimulation (rTMS) on DLPFC

Intervention Type PROCEDURE

Repetitive trans-magnetic stimulation (rTMS) on DLPFC

Second group

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.

Group Type ACTIVE_COMPARATOR

Repetitive trans-magnetic stimulation (rTMS) on OFC

Intervention Type PROCEDURE

Repetitive trans-magnetic stimulation (rTMS) on OFC

Third group

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.

Group Type SHAM_COMPARATOR

Sham repetitive trans-magnetic stimulation (rTMS)

Intervention Type PROCEDURE

Sham repetitive trans-magnetic stimulation (rTMS)

Interventions

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Repetitive trans-magnetic stimulation (rTMS) on DLPFC

Intervention Type PROCEDURE

Repetitive trans-magnetic stimulation (rTMS) on OFC

Intervention Type PROCEDURE

Sham repetitive trans-magnetic stimulation (rTMS)

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No