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Clinical Trials/NCT04919785
NCT04919785
Completed
N/A

Deep Brain Stimulation in the Bed Nucleus of Stria Terminalis in Obsessive-compulsive Disorder

University Hospital, Umeå0 sites11 target enrollmentSeptember 2008

Overview

Phase
N/A
Intervention
Not specified
Conditions
Obsessive-Compulsive Disorder
Sponsor
University Hospital, Umeå
Enrollment
11
Primary Endpoint
Measuring the effect on obsessive-compulsive symptoms after treatment with DBS in the bed nucleus of stria terminalis using YBOCS
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2008
End Date
January 2019
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
University Hospital, Umeå
Responsible Party
Principal Investigator
Principal Investigator

Matilda Naesström

Principal investigator

University Hospital, Umeå

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

Outcomes

Primary Outcomes

Measuring the effect on obsessive-compulsive symptoms after treatment with DBS in the bed nucleus of stria terminalis using YBOCS

Time Frame: 1 year

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 Outcomes

  • Measuring the effect on depressive symptoms after treatment with DBS in the bed nucleus of stria terminalis using the Montgomery-Asberg Depressive Rating Scale(1 year)
  • Measuring the effect on functioning after treatment with DBS in the bed nucleus of stria terminalis using the Global Assessment of Functioning scale(1 year)

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