Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Deep brain stimulation for treatment resistant deep brain stimulation
Subjects will receive bilateral deep brain stimulation to the ventral capsule/ventral striatum. They will receive standard follow-up and device programming over the span of 52 weeks. After that, they will enter a 5 week double blinded crossover phase consisting of 2 weeks of ON or OFF stimulation, separated by 1 week of 'washout', during which stimulation will be OFF.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ON stimulation followed by OFF stimulation | Experimental | All patients complete the same 52 week open-label phase with active stimulation. After this, they enter a blinded randomized crossover phase of 2 weeks of ON (active) stimulation, followed by 2 weeks of OFF (sham) stimulation |
|
| OFF stimulation followed by ON stimulation | Experimental | All patients complete the same 52 week open-label phase with active stimulation. After this, they enter a blinded randomized crossover phase of 2 weeks of OFF (sham) stimulation, followed by 2 weeks of ON (active) stimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deep brain stimulation | Device | Active continuous deep brain stimulation of the ventral capsule/ventral striatum |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life as measured by the Short-Form 36 | Measured by the short form 36 (SF-36). The scores range from 0-100 with lower numbers indicating a worse quality of life. | 12 months compared to baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Obsessive compulsive symptoms as measured by the Yale-Brown Obsessive Compulsive Scale | Change in Yale-Brown Obsessive Compulsive Scale score at 12 months compared to baseline. The scores range from 0-40, with high scores indicating more severe obsessions and compulsions. | 12 months |
| Obsessive compulsive symptoms as measured by the Yale-Brown Obsessive Compulsive Scale during randomization |
Not provided
Inclusion Criteria:
Female or Male patients between age 18-70
DSM-V diagnosis of Obsessive Compulsive Disorder (OCD), at least 5-year illness history with a minimum score of 24 on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS).
SF-36<40
Medication-refractoriness as determined by an adequate dose and duration of psychiatric treatments (including psychotherapy and/or pharmacology) as determined by two psychiatrists associated with the study. Including specifically:
An adequate trial of cognitive behavioural therapy
Ability to provide informed consent and comply with all testing, follow-ups and study appointments and protocols
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009771 | Obsessive-Compulsive Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D046690 | Deep Brain Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
1 year of open-label treatment, followed by 5 week double blinded crossover phase consisting of 2 weeks of ON stimulation and 2 weeks of OFF stimulation separated by a 1 week washout period with OFF stimulation.
Not provided
Not provided
An independent member of the study team will perform the randomization and programming, allow for care givers, participants, investigator, and outcomes assessors to be blinded.
Yale-Brown Obsessive Compulsive Scale score during active ON stimulation compared to during OFF stimulation. The scores range from 0-40, with high scores indicating more severe obsessions and compulsions. |
| Recorded at the end of the 2 week ON and OFF stimulation periods, which occur immediately after the 52 week open-label period |