Clinical trial NCT02541812: The Use of Magnetic Brain Stimulation to Treat Obsessive Compulsive Disorder, a Pilot Study
Official title: The Efficacy of Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Obsessive Compulsive Disorder (OCD), a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Keywords: Obsessive-Compulsive Disorder
Transcranial Magnetic Stimulation
Error processing
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2015-09-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Obsessive and Compulsive Symptom Severity (Yale-Brown Obsessive Compulsive Scale)
timeFrame: Recordings: baseline; after two weeks of rTMS
Secondary outcomes:
measure: Change in Post-error Slowing
timeFrame: Recordings: baseline; after one session of rTMS
Other outcomes:
Locations:
Study officials:
affiliation: University of Manitoba
name: Mandana Modirrousta, MD PhD FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.