Transcranial Magnetic Stimulation (TMS) in Obsessive Compulsive Disorder (OCD): Mechanisms and Biomarkers

NCT02355002 | Completed Results DMC FDA Device

• 1 other identifier: 2014P002560
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test the efficacy of 1-Hz repetitive transcranial magnetic stimulation (TMS) over the pre-supplementary motor area as a treatment for obsessive compulsive disorder. Additionally, this study aims to identify the mechanisms of action of TMS and potential biomarkers and predictors of treatment response.

Conditions

Obsessive Compulsive Disorder

Outcome Measures

Primary Outcomes (1)

• Obsessive Compulsive Symptoms as Measured by Yale-Brown Obsessive Compulsive Scale (Y-BOCS)

  The Yale-Brown Obsessive Compulsive Scale (Y-BOCS) is the gold-standard, semi-structured clinician-administered assessment of OCD symptom severity. It contains 10 items ranging from 0 (no symptoms) to 4 (extreme symptoms), yielding a total possible score range from 0 to 40. Higher scores indicate more severe OCD symptom severity. We compared the efficacy of TMS to Sham in reducing OCD symptom severity over a 6-week period. Efficacy was again compared in the follow-up phase of the study in from week 6 to week 18.

  Change in YBOCS from baseline (week 0) to post-treatment (week 6), assessed every 2 weeks. Followup phase data was measured at week 18.

Secondary Outcomes (2)

• Obsessive Compulsive Beliefs as Measured by Obsessive-Compulsive Beliefs Questionnaire (OBQ)

  Change in OBQ from baseline (week 0) to post-treatment (week 6), assessed every 2 weeks. Followup phase data was measured at week 18.

• Total Number of Obsessive Symptoms is Reduced as Measured by Obsessive-Compulsive Inventory Questionnaire (OCI)-Revised

  Change in OCI from baseline (week 0) to post-treatment (week 6), assessed every 2 weeks. Followup phase data was measured at week 18.

Study Arms (2)

Active Transcranial Magnetic Stimulation (TMS) treatment

EXPERIMENTAL

In this arm subjects will receive real, active TMS with a standard, water-cooled, figure-8 shaped TMS coil.

Device: Transcranial Magnetic Stimulation

Sham-TMS treatment

SHAM COMPARATOR

This arm serves as the sham/placebo control. In TMS a sham coil is used to create a sensory experience which is similar to active TMS, but in which the magnetic field is blocked by a metal shield built into the coil.

Device: Transcranial Magnetic Stimulation

Interventions

Transcranial Magnetic Stimulation DEVICE

Transcranial magnetic stimulation uses a rapidly changing magnetic field to induce current in brain tissue non-invasively. It is common procedure in both clinical and research settings, and it has well established guidelines for safe an ethical use which maximize safety for all subjects.

Active Transcranial Magnetic Stimulation (TMS) treatment; Sham-TMS treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age.
• Proficient in English.
• A diagnosis of primary OCD (as determined by SCID).
• Yale-Brown Obsessive Compulsive Scale total score ≥ 16.
• Normal (or corrected) vision.
• Stable medication regimen or medication free for ≥ 12 weeks prior to study; benzodiazepine free ≥ 2 weeks.
• Right-handed (Edinburgh Handedness Inventory - Short Form total score ≥ 61)
• Able to give informed consent.

You may not qualify if:

• Current or history of neurologic or psychiatric disease (e.g., mental retardation, dementia, brain damage, or other cognitive impairment) that would interfere with ability to engage in TMS
• Psychopathology not appropriate for the treatment (e.g., manic episode or psychosis)
• Substance abuse or dependence that is current or within the last six months or use of an illicit drug that is not prescribed, as indicated by a urine drug screen and/or clinical inference.
• Use of benzodiazepines or anticonvulsants within 2 weeks prior to study (to be ruled out by a urine drug screen).
• Use of Tricyclic Antidepressants (e.g. Clomipramine).
• Use of other psychotropic medications (e.g., SSRIs) will be allowed provided the dose has been stable for \> 12 weeks.
• Documented resistance to 4 or more valid pharmacological trials of 2 or more different medication classes (e.g. SSRIs and TCAs).
• Previous exposure to TMS.
• Major/chronic medical conditions.
• History of head injury resulting in prolonged loss of consciousness and/or neurological sequelae.
• Prior neurosurgical procedure.
• Metal in the body, metal injury to the eyes.
• History of seizures.
• Implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator, TENS unit, or ventriculo-peritoneal shunt
• Pregnancy; breastfeeding or nursing; for women of childbearing a pregnancy test (to be ruled out by urine β-HCG) will be conducted prior to study.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• Rossi S, Hallett M, Rossini PM, Pascual-Leone A; Safety of TMS Consensus Group. Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research. Clin Neurophysiol. 2009 Dec;120(12):2008-2039. doi: 10.1016/j.clinph.2009.08.016. Epub 2009 Oct 14.

  PMID: 19833552 BACKGROUND

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Results Point of Contact

• Title: Drs. Joan Camprodon and Sabine Wilhelm
• Organization: Massachusetts General Hospital

jcamprodon@mgh.harvard.edu

6177265340

Study Officials

• Joan A Camprodon, MD, MPH, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MPH, PhD

Study Record Dates

• First Submitted: January 30, 2015
• First Posted: February 4, 2015
• Study Start: May 1, 2015
• Primary Completion: October 29, 2021
• Study Completion: October 29, 2021
• Last Updated: February 13, 2026
• Results First Posted: June 8, 2023

Record last verified: 2023-05

Locations

US (1)