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

Obsessive-Compulsive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02904356
• Other study ID #: AAAQ8771
• Status: Terminated
• Phase: N/A
• Start date: October 2016
• Est. completion date: October 2018

Study information

• Verified date: November 2019
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Disease
• Obsessive-Compulsive Disorder

Intervention

Device:
• Repetitive transcranial magnetic stimulation
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).

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 1 month