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Low Frequency TMS on DLPFC and OFC in OCD Patients

Primary Purpose

Psychiatric Disorder

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Repetitive trans-magnetic stimulation (rTMS) on DLPFC
Repetitive trans-magnetic stimulation (rTMS) on OFC
Sham repetitive trans-magnetic stimulation (rTMS)
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychiatric Disorder focused on measuring OCD, rTMS, right orbitofrontal cortex

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Eman Khedr

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Sham Comparator

Arm Label

First group

Second group

Third group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
June 24, 2017
Last Updated
September 12, 2020
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT03207633
Brief Title
Low Frequency TMS on DLPFC and OFC in OCD Patients
Official Title
Comparative Study of the Therapeutic Effect of Low Frequency TMS on DLPFC and OFC in OCD Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
July 30, 2018 (Actual)
Study Completion Date
July 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychiatric Disorder
Keywords
OCD, rTMS, right orbitofrontal cortex

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
First group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Second group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Third group
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Repetitive trans-magnetic stimulation (rTMS) on DLPFC
Intervention Description
Repetitive trans-magnetic stimulation (rTMS) on DLPFC
Intervention Type
Procedure
Intervention Name(s)
Repetitive trans-magnetic stimulation (rTMS) on OFC
Intervention Description
Repetitive trans-magnetic stimulation (rTMS) on OFC
Intervention Type
Procedure
Intervention Name(s)
Sham repetitive trans-magnetic stimulation (rTMS)
Intervention Description
Sham repetitive trans-magnetic stimulation (rTMS)
Primary Outcome Measure Information:
Title
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Description
Assessment of Obsessive Compulsive disorder using (Y-BOCS)
Time Frame
Three months
Title
Hamilton Anxiety Rating Scale (HAM-A)
Description
Assessment of anxiety using Hamilton scale
Time Frame
Three months
Title
Beck Depression Inventory
Description
Assessment of Depression using Beck depression inventory
Time Frame
Three months
Title
Clinical Global Impression-Severity scale (CGI-S)
Description
Assessment of clinical severity using CGI-S
Time Frame
Three months
Title
Montreal Cognitive Assessment (MoCA)
Description
Assessment of cognitive function using (MoCA)
Time Frame
Three months
Secondary Outcome Measure Information:
Title
Changes of cortical excitability parameters (RMT and CSP)
Description
Measurment of changes of cortical excitability parameters (RMT and CSP) before and after sessions in the three groups.
Time Frame
Ten days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eman M Khedr
Organizational Affiliation
Professor of Neurology, Faculty of Medicine, Assiut University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eman Khedr
City
Assiut
ZIP/Postal Code
11517
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Low Frequency TMS on DLPFC and OFC in OCD Patients

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