Obsessive-Compulsive Disorder
Conditions
Brief summary
Deep brain stimulation for treatment resistant deep brain stimulation
Detailed description
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.
Interventions
DEVICEDeep brain stimulation
Active continuous deep brain stimulation of the ventral capsule/ventral striatum
Sponsors
Sunnybrook Health Sciences Centre
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Female or Male patients between age 18-70 2. 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). 3. SF-36\<40 4. 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: 1. Failed adequate trial of two or more medications accepted as first line in the treatment of OCD 2. Attempted augmentation, if tolerated, by at least 1 medications known to be first line treatments for OCD 5. An adequate trial of cognitive behavioural therapy 6. Ability to provide informed consent and comply with all testing, follow-ups and study appointments and protocols
Exclusion criteria
1. Any past or current evidence of psychosis or mania (patients with co-morbid depression will not be excluded from the study) 2. Active neurologic disease, such as epilepsy 3. Alcohol or substance dependence or abuse in the last 6 months, excluding caffeine and nicotine 4. Current suicidal ideation 5. Any contraindication to MRI scanning 6. No contraindication for DBS surgery 7. Presence of significant cognitive impairment 8. Likely to relocate or move out of the country during the study's duration 9. Presence of clinical and/or neurological conditions that may significantly increase the risk of the surgical procedure. 10. Currently pregnant (as determined by history and serum HCG) or lactating; for females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life as measured by the Short-Form 36 | 12 months compared to baseline | Measured by the short form 36 (SF-36). The scores range from 0-100 with lower numbers indicating a worse quality of life. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Obsessive compulsive symptoms as measured by the Yale-Brown Obsessive Compulsive Scale | 12 months | 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. |
| Obsessive compulsive symptoms as measured by the Yale-Brown Obsessive Compulsive Scale during randomization | Recorded at the end of the 2 week ON and OFF stimulation periods, which occur immediately after the 52 week open-label period | 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. |
Countries
Canada
Outcome results
None listed