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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02541812
Other study ID # B2009:077
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 2011
Est. completion date June 2015

Study information

Verified date August 2015
Source University of Manitoba
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

A battery of cognitive tasks designed to selectively measure several aspects of anterior cingulate cortex (ACC) function, will be administered before and after one session of rTMS in all participants. The first neurocognitive session will be administered in a separate day from the rTMS session. The second neurocognitive session will be performed immediately after rTMS and in the same day. Participants will perform five tasks designed to test: error processing, error likelihood assessment, meta-memory, response inhibition, and affect recognition.

The rTMS paradigm will consist of four short trains of magnetic pulses which include 5 minutes of stimulation with 1Hz frequency (overall 1200 pulses in one session) with an intensity of 110% of each participant's motor threshold, and 2 minute intervals between the stimulation trains. Stimulation will be applied over the dorsal ACC (dACC) using a double-cone rTMS coil. dACC will be precisely targeted using neuronavigation software loaded a high resolution MRI of each subjects' brain.

OCD patients will go on to receive two weeks (10 sessions) of daily rTMS treatments using the same protocol described above.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date June 2015
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Diagnosed obsessive compulsive disorder

- Not currently receiving cognitive behavioural therapy

- Not currently on any medication or only taking one selective serotonin reuptake inhibitor (SSRI)

Exclusion Criteria:

- History of psychotic episodes

- History of neurological illness

- Previous head injury

- Active alcohol or substance abuse

- History of seizure disorders

- Currently pregnant

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Transcranial Magnetic Stimulation
A non-invasive method for brain stimulation

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Manitoba

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Change in Post-error Slowing Post-error slowing (PES) is the difference in response time on trials following an error to trials following a correct response. Higher numbers indicate more post-error slowing (i.e. longer response times following an error trial compared to following a correct trial). The outcome measure is the change in PES from baseline to following one session of rTMS. Recordings: baseline; after one session of rTMS
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