Low Frequency TMS on DLPFC and OFC in OCD Patients

Psychiatric Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03207633
• Other study ID #: Low frequency TMS in OCD
• Status: Completed
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: July 30, 2018

Study information

• Verified date: September 2020
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 30, 2018
• Est. primary completion date: July 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorders
• Problem Behavior
• Psychiatric Disorder

Intervention

Procedure:
• Repetitive trans-magnetic stimulation (rTMS) on DLPFC
Repetitive trans-magnetic stimulation (rTMS) on DLPFC
• Repetitive trans-magnetic stimulation (rTMS) on OFC
Repetitive trans-magnetic stimulation (rTMS) on OFC
• Sham repetitive trans-magnetic stimulation (rTMS)
Sham repetitive trans-magnetic stimulation (rTMS)

Locations

Country	Name	City	State
Egypt	Eman Khedr	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

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