Deep Brain Stimulation (DBS) for the Treatment of Refractory Obsessive-compulsive Disorder (OCD)

Obsessive-Compulsive Disorder Clinical Trial

Official title:

Deep Brain Stimulation (DBS) of the Ventral Capsule/Ventral Striatum (VC/VS) for the Treatment of Refractory Obsessive-compulsive Disorder (OCD)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04217408
• Other study ID #: 111-2018
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: December 19, 2024

Study information

• Verified date: December 2023
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Deep brain stimulation for treatment resistant deep brain stimulation

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: December 19, 2024
• Est. primary completion date: December 19, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Obsessive-Compulsive Disorder

Intervention

Device:
• Deep brain stimulation
Active continuous deep brain stimulation of the ventral capsule/ventral striatum

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Obsessive compulsive symptoms as measured by the Yale-Brown Obsessive Compulsive Scale during randomization	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