Deep Brain Stimulation in Severe Obsessive-compulsive Disorder

Not Applicable

Completed

• Conditions: Obsessive-Compulsive Disorder
• Interventions: Device: Deep brain stimulation

• Registration Number: NCT04919785
• Lead Sponsor: University Hospital, Umeå

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Primary Completion: 2018-11
• Study Completion: 2019-01
• Study First Submitted: 2021-05-07
• Status Verified: 2021-06
• Study First Submitted QC: 2021-06-03
• Last Update Submitted: 2021-06-03
• Study First Posted: 2021-06-09
• Last Update Posted: 2021-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Deep brain stimulation	Deep brain stimulation	Deep brain stimulation in the bed nucleus of stria terminalis

Primary Outcome Measures

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

Name	Time	Method
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	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	1 year	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).