NCT02904356

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2016

Completed
25 days until next milestone

First Posted

Study publicly available on registry

September 19, 2016

Completed
12 days until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

November 25, 2019

Completed
Last Updated

November 25, 2019

Status Verified

November 1, 2019

Enrollment Period

2 years

First QC Date

August 25, 2016

Results QC Date

October 15, 2019

Last Update Submit

November 6, 2019

Conditions

Obsessive-Compulsive Disorder

Keywords

OCDTMSNeuromodulationObsessive-Compulsive DisorderTranscranial Magnetic StimulationImaging

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Brainsway H-coil for rTMS

EXPERIMENTAL

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

Device: Repetitive transcranial magnetic stimulation

Interventions

Repetitive transcranial magnetic stimulationDEVICE

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).

Also known as: rTMS
Brainsway H-coil for rTMS

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Limitations and Caveats

PI left institution, no data was collected and analyzed in the specified manner.

Results Point of Contact

Title
Sameer Sheth, MD, PhD
Organization
Baylor College of Medicine
sasheth@bcm.edu
713-798-4696

Study Officials

  • Sameer Sheth, MD

    Columbia University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2016

First Posted

September 19, 2016

Study Start

October 1, 2016

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

November 25, 2019

Results First Posted

November 25, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)