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

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

Deep brain stimulation for treatment resistant deep brain stimulation

Study Overview

• Status: Active, not recruiting
• Conditions: Obsessive-Compulsive Disorder
• Intervention / Treatment: Device: 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.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ON stimulation followed by OFF stimulation; 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	Device: Deep brain stimulation; Active continuous deep brain stimulation of the ventral capsule/ventral striatum
Experimental: OFF stimulation followed by ON stimulation; 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	Device: Deep brain stimulation; Active continuous deep brain stimulation of the ventral capsule/ventral striatum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Estimated): December 19, 2024
• Study Completion (Estimated): December 19, 2024

Study Registration Dates

• First Submitted: January 2, 2020
• First Submitted That Met QC Criteria: January 2, 2020
• First Posted (Actual): January 3, 2020

Study Record Updates

• Last Update Posted (Estimated): December 8, 2023
• Last Update Submitted That Met QC Criteria: December 1, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Anxiety Disorders; Compulsive Personality Disorder; Obsessive-Compulsive Disorder
• Other Study ID Numbers: 111-2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No