NCT02541812

Brief Summary

The purpose of this study is two-fold: first, to observe the effect of one session of repetitive transcranial magnetic stimulation (rTMS) on the error-prediction abilities of patients with obsessive compulsive disorder (OCD) as well as healthy individuals; and second, to observe the clinical effect of 10 sessions of rTMS in patients with OCD.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2011

Longer than P75 for not_applicable

Status
completed

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

Study Start

First participant enrolled

July 1, 2011

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 2, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 4, 2015

Completed
5 years until next milestone

Results Posted

Study results publicly available

August 27, 2020

Completed
Last Updated

September 17, 2020

Status Verified

August 1, 2015

Enrollment Period

3.9 years

First QC Date

September 2, 2015

Results QC Date

August 11, 2020

Last Update Submit

August 28, 2020

Conditions

Keywords

Obsessive-Compulsive DisorderTranscranial Magnetic StimulationError processing

Outcome Measures

Primary Outcomes (1)

  • Change in Obsessive and Compulsive Symptom Severity (Yale-Brown Obsessive Compulsive Scale)

    Yale-Brown Obsessive Compulsive Scale. Minimum value = 0. Maximum value = 40. Higher scores indicate greater severity of obsessive and compulsive symptoms.

    Recordings: baseline; after two weeks of rTMS

Secondary Outcomes (1)

  • Change in Post-error Slowing

    Recordings: baseline; after one session of rTMS

Study Arms (2)

Patients

EXPERIMENTAL

Ten sessions of 1Hz repetitive Transcranial Magnetic Stimulation of the dorsal anterior cingulate cortex in patients with obsessive compulsive disorder

Device: Transcranial Magnetic Stimulation

Healthy Control Subjects

ACTIVE COMPARATOR

One session of 1Hz repetitive Transcranial Magnetic Stimulation of the dorsal anterior cingulate cortex in healthy control individuals

Device: Transcranial Magnetic Stimulation

Interventions

A non-invasive method for brain stimulation

Healthy Control SubjectsPatients

Eligibility Criteria

Age18 Years - 65 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

Related Publications (1)

  • Modirrousta M, Meek BP, Sareen J, Enns MW. Impaired trial-by-trial adjustment of cognitive control in obsessive compulsive disorder improves after deep repetitive transcranial magnetic stimulation. BMC Neurosci. 2015 Oct 9;16:63. doi: 10.1186/s12868-015-0205-z.

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Results Point of Contact

Title
Dr. Mandana Modirrousta
Organization
University of Manitoba

Study Officials

  • Mandana Modirrousta, MD PhD FRCPC

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2015

First Posted

September 4, 2015

Study Start

July 1, 2011

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

September 17, 2020

Results First Posted

August 27, 2020

Record last verified: 2015-08