Low Frequency TMS on DLPFC and OFC in OCD Patients

NCT03207633 | Completed

• 1 other identifier: Low frequency TMS in OCD
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychiatric Disorder

Keywords

OCD, rTMS, right orbitofrontal cortex

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• Changes of cortical excitability parameters (RMT and CSP)

  Ten days

Study Arms (3)

First group

ACTIVE COMPARATOR

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

Second group

ACTIVE COMPARATOR

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

Third group

SHAM COMPARATOR

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)

Interventions

Repetitive trans-magnetic stimulation (rTMS) on DLPFC PROCEDURE

Repetitive trans-magnetic stimulation (rTMS) on DLPFC

First group

Repetitive trans-magnetic stimulation (rTMS) on OFC PROCEDURE

Repetitive trans-magnetic stimulation (rTMS) on OFC

Second group

Sham repetitive trans-magnetic stimulation (rTMS) PROCEDURE

Sham repetitive trans-magnetic stimulation (rTMS)

Third group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• (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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Eman Khedr

Asyut, 11517, Egypt

Location

MeSH Terms

Conditions

Mental Disorders

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Eman M Khedr

  Professor of Neurology, Faculty of Medicine, Assiut University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professorf

Study Record Dates

• First Submitted: June 24, 2017
• First Posted: July 5, 2017
• Study Start: July 1, 2017
• Primary Completion: July 30, 2018
• Study Completion: July 30, 2018
• Last Updated: September 16, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)