Recruiting

Deep Brain StimulationDeep Brain Stimulation for Refractory Obsessive-Compulsive Disorder

Sponsor:

Nader Pouratian

Code:

NCT06660225

Conditions

Obsessive-Compulsive Disorder

Eligibility Criteria

Sex: All

Age: 22 - 70+

Healthy Volunteers: Not accepted

Interventions

Medtronic Percept Deep Brain Stimulation Therapy [Sham Control Stimulation]

Medtronic Percept Deep Brain Stimulation Therapy [Therapeutic stimulation]

Study Details

Brief summary:

The goal of this clinical trial is to learn if deep brain stimulation (DBS) works to treat refractory obsessive-compulsive disorder (OCD). The main questions it aims to answer are:

Assess the effects of the anteromedial sub-thalamic nucleus (amSTN)stimulation on obsessive/compulsive symptoms.
Map the amSTN using neuronal responses \[single unit and local field potentials (LFP) recordings\] at rest and under high frequency stimulation during surgery.
Record chronic brain activity with the implanted pulse generator and look for neuronal signatures correlated with symptom severity.

Researchers will compare active deep brain stimulation to a placebo (sham stimulation) to see if DBS works to treat refractory OCD.

Participants will:

Undergo surgery for the implantation of a deep brain stimulation device
Follow-up visits every three weeks with study staff
6 month follow-up for the next 2-3 years after first year of study participation is complete

Conditions

Obsessive-Compulsive Disorder

Study ID

NCT06660225

Start date

Jun, 2026

Status verified date

Apr, 2026

Completion date

Jan, 2031

Anticipated

Primary completion date

Sep, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 22 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Patients with a diagnosis of obsessive-compulsive disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM) 5 criteria
Severe OCD assessed by the Yale-Brown Obsessive-Compulsive Scale (YBOCS) with a score of more than 27
Refractory OCD; severe symptoms and impairment for more than 5 years despite pharmacological and psychological treatment.
Have failed to improve following treatment with at least two serotonin transport inhibitors and one augmenting agent taken for an adequate time period.
Having failed to improve despite adequate cognitive behavioral therapy, as evaluated by the study psychiatrist
Patients between 22 and 75.
Ability to understand and sign written informed consent by the patient.

Exclusion Criteria:

Diagnosis of severe major depression disorder (MDD) with psychotic features.
Significant suicidal risk \[Hamilton Depression scale item 3 (suicide)>2\].
Comorbidity with any primary Psychotic Disorder, Post-Traumatic Stress Disorder (PTSD), or Eating Disorder.
History of substance or alcohol dependence or abuse in the preceding 12 months.
Significant cognitive decline, measured by Mini-Mental State Examination (MMSE <26) and Montreal Cognitive Assessment (MoCA; <24).
Any other current clinical significant neurological disorder or medical illness affecting brain function, other than a tic disorder.
Any clinically significant abnormality on preoperative MRI that would affect the safety of the surgical procedure in the opinion of the study neurosurgeon.
Any DBS contraindication, infection, coagulopathy, significant cardiac risk factors, or other medical risk factors for surgery.
Pregnancy.

Study Design

Enrollment

10 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Sham Control stimulation, then Therapeutic stimulation

Subject randomized to this arm are initially "OFF" DBS (Deep Brain Stimulation) prior to the open label period for 16 weeks and then "ON" DBS for the next 16 weeks. This is then followed by an open-label period of DBS stimulation.

experimental: Therapeutic stimulation, then Sham Control stimulation

Subjects randomized to this arm are initially "ON" DBS prior to the open label period for 16 weeks and then "OFF" DBS for the next 16 weeks. This is followed by an open-label stimulation period.

experimental: Therapeutic stimulation

All participants will transition to an open label stimulation phase for chronic therapy after the cross-over portion of this trial

Interventions

Medtronic Percept Deep Brain Stimulation Therapy [Sham Control Stimulation]

Deep brain stimulation is a surgery where bilateral electrodes are precisely inserted to specific brain targets affected by a disease state, and electrical stimulation is applied to achieve symptom relief. DBS is a reversible and adjustable treatment option and is now a preferred alternative to neurosurgical ablation. Sham Stimulation=DBS OFF

Medtronic Percept Deep Brain Stimulation Therapy [Therapeutic stimulation]

Primary outcome measure

Efficacy of amSTN stimulation on OCD symptoms as measured by YBOCS [ Time Frame: 36 months ]
Incidence of Adverse events [ Time Frame: 36 months ]

Central Contacts and Locations

Central contacts

Nader Pouratian, M.D., Ph.D.

2146486630 Nader.Pouratian@UTSouthwestern.edu

Tash Mupambo

214-645-1355 Tashinga.Mupambo@UTSouthwestern.edu

Locations

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Nader Pouratian, M.D., Ph.D.

310/274-2095 Nader.Pouratian@UTSouthwestern.edu

Principal Investigator:

Nader Pouratian, M.D., Ph.D.

More Information

Sponsor

Nader Pouratian

Last update posted

May 5, 2026

Last verified

Apr, 2026

Keywords

Obsessive
Compulsive
Deep Brain Stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Nader Pouratian on 2026-05-05.