Low Frequency TMS on DLPFC and OFC in OCD Patients

September 12, 2020 updated by: Eman M. Khedr, Assiut University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt, 11517
        • Eman Khedr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 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.
Procedure: Repetitive trans-magnetic stimulation (rTMS) on DLPFC
Repetitive trans-magnetic stimulation (rTMS) on DLPFC
ACTIVE_COMPARATOR: 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.
Procedure: Repetitive trans-magnetic stimulation (rTMS) on OFC
Repetitive trans-magnetic stimulation (rTMS) on OFC
SHAM_COMPARATOR: 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.
Procedure: Sham repetitive trans-magnetic stimulation (rTMS)
Sham repetitive trans-magnetic stimulation (rTMS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Time Frame: Three months
Assessment of Obsessive Compulsive disorder using (Y-BOCS)
Three months
Hamilton Anxiety Rating Scale (HAM-A)
Time Frame: Three months
Assessment of anxiety using Hamilton scale
Three months
Beck Depression Inventory
Time Frame: Three months
Assessment of Depression using Beck depression inventory
Three months
Clinical Global Impression-Severity scale (CGI-S)
Time Frame: Three months
Assessment of clinical severity using CGI-S
Three months
Montreal Cognitive Assessment (MoCA)
Time Frame: Three months
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)
Time Frame: Ten days
Measurment of changes of cortical excitability parameters (RMT and CSP) before and after sessions in the three groups.
Ten days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2017

Primary Completion (ACTUAL)

July 30, 2018

Study Completion (ACTUAL)

July 30, 2018

Study Registration Dates

First Submitted

June 24, 2017

First Submitted That Met QC Criteria

July 1, 2017

First Posted (ACTUAL)

July 5, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 16, 2020

Last Update Submitted That Met QC Criteria

September 12, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Low frequency TMS in OCD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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