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

Primary Purpose

Obsessive-Compulsive Disorder

Status

Unknown status

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Deep brain stimulation

About this trial

This is an interventional treatment trial for Obsessive-Compulsive Disorder

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:
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
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:

Any past or current evidence of psychosis or mania (patients with co-morbid depression will not be excluded from the study)
Active neurologic disease, such as epilepsy
Alcohol or substance dependence or abuse in the last 6 months, excluding caffeine and nicotine
Current suicidal ideation
Any contraindication to MRI scanning
No contraindication for DBS surgery
Presence of significant cognitive impairment
Likely to relocate or move out of the country during the study's duration
Presence of clinical and/or neurological conditions that may significantly increase the risk of the surgical procedure.
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

Sites / Locations

Sunnybrook Health Sciences CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

ON stimulation followed by OFF stimulation

OFF stimulation followed by ON stimulation

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT04217408

First Posted

January 2, 2020

Last Updated

March 15, 2021

Sponsor

Sunnybrook Health Sciences Centre

1. Study Identification

Unique Protocol Identification Number

NCT04217408

Brief Title

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

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Unknown status

Study Start Date

September 1, 2019 (Actual)

Primary Completion Date

September 19, 2021 (Anticipated)

Study Completion Date

September 19, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sunnybrook Health Sciences Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obsessive-Compulsive Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

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.

Masking

ParticipantCare ProviderInvestigatorOutcomes 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.

Allocation

Randomized

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ON stimulation followed by OFF stimulation

Arm Type

Experimental

Arm Description

Arm Title

OFF stimulation followed by ON stimulation

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Deep brain stimulation

Intervention Description

Active continuous deep brain stimulation of the ventral capsule/ventral striatum

Primary Outcome Measure Information:

Title

Quality of Life as measured by the Short-Form 36

Description

Measured by the short form 36 (SF-36). The scores range from 0-100 with lower numbers indicating a worse quality of life.

Time Frame

12 months compared to baseline

Secondary Outcome Measure Information:

Title

Obsessive compulsive symptoms as measured by the Yale-Brown Obsessive Compulsive Scale

Description

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.

Time Frame

12 months

Title

Obsessive compulsive symptoms as measured by the Yale-Brown Obsessive Compulsive Scale during randomization

Description

Time Frame

Recorded at the end of the 2 week ON and OFF stimulation periods, which occur immediately after the 52 week open-label period

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: Failed adequate trial of two or more medications accepted as first line in the treatment of OCD Attempted augmentation, if tolerated, by at least 1 medications known to be first line treatments for OCD 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: Any past or current evidence of psychosis or mania (patients with co-morbid depression will not be excluded from the study) Active neurologic disease, such as epilepsy Alcohol or substance dependence or abuse in the last 6 months, excluding caffeine and nicotine Current suicidal ideation Any contraindication to MRI scanning No contraindication for DBS surgery Presence of significant cognitive impairment Likely to relocate or move out of the country during the study's duration Presence of clinical and/or neurological conditions that may significantly increase the risk of the surgical procedure. 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sachie Sharma, BSc

Phone

416-480-6100

Ext

3254

sachie.sharma@sunnybrook.ca

Facility Information:

Facility Name

Sunnybrook Health Sciences Centre

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4N 3M5

Country

Canada

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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