NCT02018185

Brief Summary

In a preliminary pilot study, the investigators tested the efficacy of rTMS over the medial prefrontal cortex in symptom profiles of obsessive compulsive disorder (OCD) patients. This study revealed considerable benefit in using rTMS for the treatment of OCD. In the current proposal, in a randomized clinical trial, the investigators aim to further evaluate the efficacy of rTMS in OCD in a larger sample size and for a longer period. Studies into the efficacy of rTMS in other psychiatric disorders such as depression have consistently shown that extension of the treatment to four weeks significantly increased the effect size. In the pilot study, the investigators applied rTMS for only two weeks. Although all patients consistently showed improvement in their symptoms, none of them showed complete remission of their OCD. Here, the investigators hypothesize that longer duration of rTMS treatment will have greater benefit in OCD symptom reduction.

Trial Health

33
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 23, 2013

Completed
9 days until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

March 23, 2021

Status Verified

March 1, 2021

Enrollment Period

4.9 years

First QC Date

December 10, 2013

Last Update Submit

March 22, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in obsessive and compulsive symptom severity (Yale-Brown Obsessive Compulsive Scale)

    Recordings: baseline; after two weeks of rTMS; after four weeks of rTMS; monthly for three months following the last session of rTMS

Study Arms (2)

Transcranial Magnetic Stimulation

ACTIVE COMPARATOR

Transcranial Magnetic Stimulation

Device: Transcranial Magnetic Stimulation

Sham rTMS

SHAM COMPARATOR

Sham Transcranial Magnetic Stimulation

Device: Sham Transcranial Magnetic Stimulation

Interventions

A non-invasive method for brain stimulation

Transcranial Magnetic Stimulation

Sham stimulation of the brain.

Sham rTMS

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed obsessive compulsive disorder
  • Not currently receiving cognitive behavioural therapy
  • Not currently on any medication or only taking one selective serotonin reuptake inhibitor (SSRI)

You may not qualify if:

  • History of psychotic episodes
  • History of neurological illness
  • Previous head injury
  • Active alcohol or substance abuse
  • History of seizure disorders
  • Currently pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Boniface Hospital

Winnipeg, Manitoba, R3P2B4, Canada

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2013

First Posted

December 23, 2013

Study Start

January 1, 2014

Primary Completion

December 1, 2018

Study Completion

August 1, 2021

Last Updated

March 23, 2021

Record last verified: 2021-03

Locations