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Repetitive Transcranial Magnetic Stimulation (rTMS) for Obsessive-Compulsive Disorder (OCD)

Primary Purpose

Obsessive-Compulsive Disorder

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Repetitive transcranial magnetic stimulation

About this trial

This is an interventional other trial for Obsessive-Compulsive Disorder focused on measuring OCD, TMS, Neuromodulation, Obsessive-Compulsive Disorder, Transcranial Magnetic Stimulation, Imaging

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Primary diagnosis of Obsessive Compulsive Disorder, as confirmed by the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) (SCID).
Subjects should have at least a moderate level of OCD severity as defined by a Yale-Brown Obsessive Compulsive Disorder Scale (YBOCS) score of ≥ 20.

Exclusion Criteria:

Individuals diagnosed by the investigators with the following conditions: Bipolar Disorder (lifetime), any Psychotic Disorder (lifetime), history of substance abuse or dependence within the past year (expect nicotine and caffeine).
An Axis II Personality Disorder, which in the judgment of the investigator may hinder the patient in completing the procedures required by the study protocol.
Individuals with a clinically defined neurological disorder including, but not limited to: stroke, tics, space occupying brain lesion, any history of seizures except those therapeutically induced by electroconvulsive therapy (ECT), history of cerebrovascular accident, transient ischemic attack within two years, cerebral aneurysm, dementia, Parkinson's Disease, Huntington Chorea, Multiple Sclerosis.
Increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure (such as after large infarctions or trauma), or history of significant head trauma with loss of consciousness for >5 minutes.
History of treatment with rTMS therapy for any disorder.
History of treatment with Deep Brain Stimulation.
Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease.
Intracranial implants (e.g. aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed.
Current illicit drug use.

Sites / Locations

Columbia University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Brainsway H-coil for rTMS

Arm Description

Brainsway H-coil for repetitive transcranial magnetic stimulation: High-frequency rTMS will be administered to the medial prefrontal cortex for 3 weeks.

Outcomes

Primary Outcome Measures

Change in Functional Magnetic Resonance Imaging (fMRI) BOLD Response

Change in blood-oxygen-level dependent (BOLD) correlates corresponding to task engagement before and after rTMS will be assessed.

Secondary Outcome Measures

Full Information

NCT ID

NCT02904356

First Posted

August 25, 2016

Last Updated

November 6, 2019

Sponsor

Columbia University

1. Study Identification

Unique Protocol Identification Number

NCT02904356

Brief Title

Repetitive Transcranial Magnetic Stimulation (rTMS) for Obsessive-Compulsive Disorder (OCD)

Official Title

Repetitive Transcranial Magnetic Stimulation (rTMS) for Obsessive-Compulsive Disorder (OCD)

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Terminated

Why Stopped

PI left institution

Study Start Date

October 2016 (Actual)

Primary Completion Date

October 2018 (Actual)

Study Completion Date

October 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Columbia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The study aims to assess the impact of repetitive transcranial magnetic stimulation (rTMS) on brain imaging and neurophysiological measures of cognitive control in patients with Obsessive-Compulsive Disorder (OCD).

Detailed Description

With a prevalence of nearly 3%, obsessive-compulsive disorder (OCD) is one of the most common psychiatric disorders in the US. The first line of treatment for OCD comprises pharmacotherapy with serotonin reuptake inhibitors (SRIs) and cognitive behavioral therapy (CBT). Although adherence to these therapies has been shown to improve symptoms in at least half of patients, some have residual symptoms and a small percentage are refractory to standard therapies. Transcranial magnetic stimulation (TMS) may offer an alternate, less-invasive therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obsessive-Compulsive Disorder

Keywords

OCD, TMS, Neuromodulation, Obsessive-Compulsive Disorder, Transcranial Magnetic Stimulation, Imaging

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Brainsway H-coil for rTMS

Arm Type

Experimental

Arm Description

Brainsway H-coil for repetitive transcranial magnetic stimulation: High-frequency rTMS will be administered to the medial prefrontal cortex for 3 weeks.

Intervention Type

Device

Intervention Name(s)

Repetitive transcranial magnetic stimulation

Other Intervention Name(s)

rTMS

Intervention Description

High-frequency, brainsway H-coil for repetitive transcranial magnetic stimulation will be administered to the medial prefrontal cortex for 3 weeks. The intensity of stimulation will be based on resting-motor threshold (RMT).

Primary Outcome Measure Information:

Title

Change in Functional Magnetic Resonance Imaging (fMRI) BOLD Response

Description

Change in blood-oxygen-level dependent (BOLD) correlates corresponding to task engagement before and after rTMS will be assessed.

Time Frame

Up to 1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Primary diagnosis of Obsessive Compulsive Disorder, as confirmed by the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) (SCID). Subjects should have at least a moderate level of OCD severity as defined by a Yale-Brown Obsessive Compulsive Disorder Scale (YBOCS) score of ≥ 20. Exclusion Criteria: Individuals diagnosed by the investigators with the following conditions: Bipolar Disorder (lifetime), any Psychotic Disorder (lifetime), history of substance abuse or dependence within the past year (expect nicotine and caffeine). An Axis II Personality Disorder, which in the judgment of the investigator may hinder the patient in completing the procedures required by the study protocol. Individuals with a clinically defined neurological disorder including, but not limited to: stroke, tics, space occupying brain lesion, any history of seizures except those therapeutically induced by electroconvulsive therapy (ECT), history of cerebrovascular accident, transient ischemic attack within two years, cerebral aneurysm, dementia, Parkinson's Disease, Huntington Chorea, Multiple Sclerosis. Increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure (such as after large infarctions or trauma), or history of significant head trauma with loss of consciousness for >5 minutes. History of treatment with rTMS therapy for any disorder. History of treatment with Deep Brain Stimulation. Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease. Intracranial implants (e.g. aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed. Current illicit drug use.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sameer Sheth, MD

Organizational Affiliation

Columbia University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Columbia University Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Repetitive Transcranial Magnetic Stimulation (rTMS) for Obsessive-Compulsive Disorder (OCD)

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