Obsessive-Compulsive Disorder
Conditions
Keywords
Obsessive-Compulsive Disorder, Transcranial Magnetic Stimulation, Error processing
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.
Interventions
DEVICETranscranial Magnetic Stimulation
A non-invasive method for brain stimulation
Sponsors
University of Manitoba
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Obsessive and Compulsive Symptom Severity (Yale-Brown Obsessive Compulsive Scale) | Recordings: baseline; after two weeks of rTMS | Yale-Brown Obsessive Compulsive Scale. Minimum value = 0. Maximum value = 40. Higher scores indicate greater severity of obsessive and compulsive symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Post-error Slowing | Recordings: baseline; after one session of rTMS | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients Ten sessions of 1Hz repetitive Transcranial Magnetic Stimulation of the dorsal anterior cingulate cortex in patients with obsessive compulsive disorder
Transcranial Magnetic Stimulation: A non-invasive method for brain stimulation | 10 |
| Healthy Control Subjects One session of 1Hz repetitive Transcranial Magnetic Stimulation of the dorsal anterior cingulate cortex in healthy control individuals
Transcranial Magnetic Stimulation: A non-invasive method for brain stimulation | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Healthy Control Subjects | Total | Patients |
|---|---|---|---|
| Age, Continuous | 29.5 years STANDARD_DEVIATION 12.1 | 29.2 years STANDARD_DEVIATION 12.1 | 28.7 years STANDARD_DEVIATION 12.1 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Canada | 10 participants | 20 participants | 10 participants |
| Sex: Female, Male Female | 4 Participants | 12 Participants | 8 Participants |
| Sex: Female, Male Male | 6 Participants | 8 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
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.
Time frame: Recordings: baseline; after two weeks of rTMS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients | Change in Obsessive and Compulsive Symptom Severity (Yale-Brown Obsessive Compulsive Scale) | -39.4 Percent change | Standard Deviation 15.4 |
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.
Time frame: Recordings: baseline; after one session of rTMS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients | Change in Post-error Slowing | 1.4 ms | Standard Deviation 5.8 |
| Healthy Control Subjects | Change in Post-error Slowing | -3.0 ms | Standard Deviation 4.8 |