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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04217408
Recruitment Status : Recruiting
First Posted : January 3, 2020
Last Update Posted : January 3, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. Nir Lipsman, Sunnybrook Health Sciences Centre

Brief Summary:
Deep brain stimulation for treatment resistant deep brain stimulation

Condition or disease Intervention/treatment Phase
Obsessive-Compulsive Disorder Device: Deep brain stimulation Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
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.
Masking: Quadruple (Participant, Care Provider, 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.
Primary Purpose: Treatment
Official Title: Deep Brain Stimulation (DBS) of the Ventral Capsule/Ventral Striatum (VC/VS) for the Treatment of Refractory Obsessive-compulsive Disorder (OCD)
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : May 25, 2021
Estimated Study Completion Date : May 25, 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Quality of Life as measured by the Short-Form 36 [ Time Frame: 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 Outcome Measures :
  1. Obsessive compulsive symptoms as measured by the Yale-Brown Obsessive Compulsive Scale [ Time Frame: 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.

  2. Obsessive compulsive symptoms as measured by the Yale-Brown Obsessive Compulsive Scale during randomization [ 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 ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04217408


Contacts
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Contact: Sachie Sharma, BSc 416-480-6100 ext 3254 sachie.sharma@sunnybrook.ca

Locations
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Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
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Responsible Party: Dr. Nir Lipsman, Dr Nir Lipsman, MD, PhD, Neurosurgeon, Scientist, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT04217408    
Other Study ID Numbers: 111-2018
First Posted: January 3, 2020    Key Record Dates
Last Update Posted: January 3, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Personality Disorders
Mental Disorders
Anxiety Disorders