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

NCT04217408 | Unknown

• 1 other identifier: 111-2018
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Deep brain stimulation for treatment resistant deep brain stimulation

Conditions

Obsessive-Compulsive Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  12 months

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

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

Study Arms (2)

ON stimulation followed by OFF stimulation

EXPERIMENTAL

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

OFF stimulation followed by ON stimulation

EXPERIMENTAL

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

Interventions

Deep brain stimulation DEVICE

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

OFF stimulation followed by ON stimulation; ON stimulation followed by OFF stimulation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Nir Lipsman, MD, PhD, Neurosurgeon, Scientist

Model Details: 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.

Study Record Dates

• First Submitted: January 2, 2020
• First Posted: January 3, 2020
• Study Start: September 1, 2019
• Primary Completion: December 19, 2024
• Study Completion: December 19, 2024
• Last Updated: December 8, 2023

Record last verified: 2023-12

Locations

CA (1)