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Deep Brain Stimulation in Severe Obsessive-compulsive Disorder (DBS in OCD)

Primary Purpose

Obsessive-Compulsive Disorder

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Deep brain stimulation
Sponsored by
University Hospital, Umeå
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive-Compulsive Disorder focused on measuring Deep brain stimulation, Bed nucleus of stria terminalis, Obsessive-compulsive disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Severe OCD according to the Diagnostic and Statistical Manual of Mental Disorders: DSM-IV
  • YBOCS score of at least 25/40
  • Disease duration of ≥5 years with persistent disabling symptoms despite adequate trials with at least 3 different serotonergic acting antidepressants, augmentation with antipsychotics, and CBT
  • Only patients between 18 and 65 years of age who could understand and comply with instructions and provide their own written consent.

Exclusion Criteria:

  • Current psychotic or substance abuse disorder
  • Clinically significant medical disorder, or previous brain surgery

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Deep brain stimulation

    Arm Description

    Deep brain stimulation in the bed nucleus of stria terminalis

    Outcomes

    Primary Outcome Measures

    Measuring the effect on obsessive-compulsive symptoms after treatment with DBS in the bed nucleus of stria terminalis using YBOCS
    The primary outcome measure was the psychiatrist-rated YBOCS at one year, with response defined as ≥ 35% decrease in YBOCS score and partial response as a 25-34% decrease. In YBOCS is a 10-item clinically rated scale where the items are divided by obsessions and compulsions. The scale measures the severity of OCD by time spent on obsessions/compulsions, level of anxiety and decrease of functioning caused by OCD symptoms and ability to control obsessions and compulsions. Maximum points on the scale are 40, where 0-7 points indicates subclinical, 8-15 mild, 16-23 moderate, 24 - 32 severe and 33- 40 extreme OCD symptoms

    Secondary Outcome Measures

    Measuring the effect on depressive symptoms after treatment with DBS in the bed nucleus of stria terminalis using the Montgomery-Asberg Depressive Rating Scale
    The Montgomery-Asberg Depressive Rating Scale is a 10-item clinically rated scale of common symptoms in major depressive disorder. The scale measures severity of depressive symptoms with a maximum score of 60 where 0-6 indicates normal levels, 7 - 19 mild, 20 - 34 moderate and >34 severe depression.
    Measuring the effect on functioning after treatment with DBS in the bed nucleus of stria terminalis using the Global Assessment of Functioning scale
    The Global Assessment of Functioning is a numeric clinician rating scale to rate social, occupational, and psychological functioning. Scores range from 100 (high function) to 0 (sever impairment).

    Full Information

    First Posted
    May 7, 2021
    Last Updated
    June 3, 2021
    Sponsor
    University Hospital, Umeå
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04919785
    Brief Title
    Deep Brain Stimulation in Severe Obsessive-compulsive Disorder
    Acronym
    DBS in OCD
    Official Title
    Deep Brain Stimulation in the Bed Nucleus of Stria Terminalis in Obsessive-compulsive Disorder
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2008 (Actual)
    Primary Completion Date
    November 2018 (Actual)
    Study Completion Date
    January 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University Hospital, Umeå

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Deep brain stimulation is an established treatment for movement disorders. New indications for deep brain stimulation are under investigation, among them severe and treatment-resistant obsessive-compulsive disorder. Here, the investigators investigate clinical outcomes, safety and mechanism of action of DBS in the BNST in a series of 11 participants with severe therapy-refractory OCD.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obsessive-Compulsive Disorder
    Keywords
    Deep brain stimulation, Bed nucleus of stria terminalis, Obsessive-compulsive disorder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    11 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Deep brain stimulation
    Arm Type
    Experimental
    Arm Description
    Deep brain stimulation in the bed nucleus of stria terminalis
    Intervention Type
    Device
    Intervention Name(s)
    Deep brain stimulation
    Intervention Description
    Stereotactic functional neurosurgery was first developed in 1947 and is today an established treatment for movement disorders. The surgical procedure is initiated by mounting a stereotactic frame on the head of the patient and a magnetic resonance image (MRI) is performed. Using a computerized navigational system the target structure is identified on the MRI and a trajectory chosen. In the operating theatre a burrhole is made on each side of the midline for the implantation of two electrodes. The electrodes are about 1.3 mm in diameter with several contacts at their distal end. An extension cable is tunneled under the skin, connecting the electrodes with a neuropacemaker placed below the clavicle in a subcutaneous pocket. The hospitalization time after surgery is dependent on the time needed for programming of the device, but the patients can usually return home within 3-5 days.
    Primary Outcome Measure Information:
    Title
    Measuring the effect on obsessive-compulsive symptoms after treatment with DBS in the bed nucleus of stria terminalis using YBOCS
    Description
    The primary outcome measure was the psychiatrist-rated YBOCS at one year, with response defined as ≥ 35% decrease in YBOCS score and partial response as a 25-34% decrease. In YBOCS is a 10-item clinically rated scale where the items are divided by obsessions and compulsions. The scale measures the severity of OCD by time spent on obsessions/compulsions, level of anxiety and decrease of functioning caused by OCD symptoms and ability to control obsessions and compulsions. Maximum points on the scale are 40, where 0-7 points indicates subclinical, 8-15 mild, 16-23 moderate, 24 - 32 severe and 33- 40 extreme OCD symptoms
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Measuring the effect on depressive symptoms after treatment with DBS in the bed nucleus of stria terminalis using the Montgomery-Asberg Depressive Rating Scale
    Description
    The Montgomery-Asberg Depressive Rating Scale is a 10-item clinically rated scale of common symptoms in major depressive disorder. The scale measures severity of depressive symptoms with a maximum score of 60 where 0-6 indicates normal levels, 7 - 19 mild, 20 - 34 moderate and >34 severe depression.
    Time Frame
    1 year
    Title
    Measuring the effect on functioning after treatment with DBS in the bed nucleus of stria terminalis using the Global Assessment of Functioning scale
    Description
    The Global Assessment of Functioning is a numeric clinician rating scale to rate social, occupational, and psychological functioning. Scores range from 100 (high function) to 0 (sever impairment).
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Severe OCD according to the Diagnostic and Statistical Manual of Mental Disorders: DSM-IV YBOCS score of at least 25/40 Disease duration of ≥5 years with persistent disabling symptoms despite adequate trials with at least 3 different serotonergic acting antidepressants, augmentation with antipsychotics, and CBT Only patients between 18 and 65 years of age who could understand and comply with instructions and provide their own written consent. Exclusion Criteria: Current psychotic or substance abuse disorder Clinically significant medical disorder, or previous brain surgery

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    27103550
    Citation
    Naesstrom M, Blomstedt P, Bodlund O. A systematic review of psychiatric indications for deep brain stimulation, with focus on major depressive and obsessive-compulsive disorder. Nord J Psychiatry. 2016 Oct;70(7):483-91. doi: 10.3109/08039488.2016.1162846. Epub 2016 Apr 22.
    Results Reference
    background
    PubMed Identifier
    33540102
    Citation
    Naesstrom M, Hariz M, Stromsten L, Bodlund O, Blomstedt P. Deep Brain Stimulation in the Bed Nucleus of Stria Terminalis in Obsessive-Compulsive Disorder-1-Year Follow-up. World Neurosurg. 2021 May;149:e794-e802. doi: 10.1016/j.wneu.2021.01.097. Epub 2021 Feb 1.
    Results Reference
    result

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    Deep Brain Stimulation in Severe Obsessive-compulsive Disorder

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