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

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

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.

Study Overview

• Status: Completed
• Conditions: Obsessive-Compulsive Disorder
• Intervention / Treatment: Device: Deep brain stimulation

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Deep brain stimulation; Deep brain stimulation in the bed nucleus of stria terminalis

Device: Deep brain stimulation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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).	1 year

Collaborators and Investigators

• Sponsor: University Hospital, Umeå

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2008
• Primary Completion (Actual): November 1, 2018
• Study Completion (Actual): January 1, 2019

Study Registration Dates

• First Submitted: May 7, 2021
• First Submitted That Met QC Criteria: June 3, 2021
• First Posted (Actual): June 9, 2021

Study Record Updates

• Last Update Posted (Actual): June 9, 2021
• Last Update Submitted That Met QC Criteria: June 3, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Deep brain stimulation; Obsessive-compulsive disorder; Bed nucleus of stria terminalis
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Personality Disorders; Anxiety Disorders; Disease; Compulsive Personality Disorder; Obsessive-Compulsive Disorder
• Other Study ID Numbers: 08-090M

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No