Deep Brain Stimulation for Obsessive-compulsive Disorder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-11

Study Completion Date

2030-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this clinical trial is to evaluate the treatment method of deep brain stimulation (DBS) in patients diagnosed with severe and treatment-resistant obsessive-compulsive disorder (OCD). DBS will be administered into the brain area of the bed nucleus of stria terminalis (BNST).

The main research questions are:

* Does active DBS in BNST reduce OCD symptoms (primary outcome)?
* Does active DBS in BNST reduce anxiety or depressive symptoms and improve the level of daily function?

The participants will be randomized to active or sham DBS in the BNST for six months and we will measure the outcomes before DBS surgery, and six months post-surgery. After the randomization phase, the participants will enter an open-label phase and receive continuous DBS in BNST. Yearly follow-ups will be conducted. The outcomes will be measured through interviews using validated psychometric scales.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Deep Brain Stimulation in Severe Obsessive-compulsive Disorder

NCT04919785

Obsessive-Compulsive Disorder

COMPLETED NA

Deep Brain Stimulation and Obsessive-compulsive Disorder

NCT01329133

Obsessive-Compulsive Disorder

COMPLETED PHASE3

Rechargeable Neurostimulators in Deep Brain Stimulation for Psychiatric Disorders

NCT02685280

Obsessive-compulsive Disorder Depression

COMPLETED NA

Subthalamic Nucleus (STN) Stimulation and Obsessive-Compulsive Disorder (OCD)

NCT00169377

Obsessive Compulsive Disorder

COMPLETED PHASE1/PHASE2

Development of Adaptive Deep Brain Stimulation for OCD

NCT04281134

Obsessive-Compulsive Disorder

ACTIVE_NOT_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obsessive-Compulsive Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

The participant and the outcome assessor are blinded to whether the participant receives active or sham stimulation.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Active stimulation

Deep brain stimulation - active stimulation

Group Type ACTIVE_COMPARATOR

Deep brain stimulation

Intervention Type DEVICE

Stimulation through a device implanted bilaterally into deep brain structures.

Sham stimulation

Deep brain stimulation - no stimulation

Group Type SHAM_COMPARATOR

Deep brain stimulation

Intervention Type DEVICE

Stimulation through a device implanted bilaterally into deep brain structures.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Deep brain stimulation

Stimulation through a device implanted bilaterally into deep brain structures.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* OCD diagnosed according to the criteria in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV).
* The patients should have received at least 16 sessions of cognitive behavioral therapy, tried three different serotonergic antidepressants in adequate doses for three months, and one serotonergic antidepressant in combination with a neuroleptic drug.
* Severe OCD symptoms: YBOCS ≥ 25 points.
* Substantial incapacity because of his/her symptoms.
* Duration of symptoms: 5 years minimum.
* Understand the consequences of participation in the study and give informed written consent.

Exclusion Criteria

* Not being able to understand the consequences of the treatment.
* Diagnosed with intellectual disability according to DSM-IV.
* Not meeting the requirements for the neurosurgery procedure.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No