Clinical trial NCT04217408: Deep Brain Stimulation (DBS) for the Treatment of Refractory Obsessive-compulsive Disorder (OCD)
Official title: Deep Brain Stimulation (DBS) of the Ventral Capsule/Ventral Striatum (VC/VS) for the Treatment of Refractory Obsessive-compulsive Disorder (OCD)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2020-01-03
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Quality of Life as measured by the Short-Form 36
timeFrame: 12 months compared to baseline
Secondary outcomes:
measure: Obsessive compulsive symptoms as measured by the Yale-Brown Obsessive Compulsive Scale
timeFrame: 12 months
measure: Obsessive compulsive symptoms as measured by the Yale-Brown Obsessive Compulsive Scale during randomization
timeFrame: Recorded at the end of the 2 week ON and OFF stimulation periods, which occur immediately after the 52 week open-label period
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
References: