Deep Brain Stimulation for Refractory Obsessive-Compulsive Disorder

NCT06660225 | Recruiting DMC FDA Device

• 1 other identifier: STU-2024-0733
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Keywords

Obsessive; Compulsive; Deep Brain Stimulation

Outcome Measures

Primary Outcomes (2)

• Efficacy of amSTN stimulation on OCD symptoms as measured by YBOCS

  Assessment of the efficacy of amSTN stimulation on OCD symptoms. This will be assessed by the Yale-Brown Obsessive-Compulsive Scale (YBOCS). Possible scores range from 0-5 where lower scores indicate better outcome.

  36 months

• Incidence of Adverse events

  Safety will be assessed with cumulative serious adverse event rate that will be Frequency at which AEs occur that are directly related to the study device.

  36 months

Secondary Outcomes (9)

• Effect of DBS on Mood and Quality of Life as measured by HAM-A survey

  36 months

• Effect of DBS on Mood and Quality of Life as measured by HAM-D21 survey

  36 months

• Effect of DBS on Mood and Quality of Life as measured by BPRS survey

  36 months

• Effect of DBS on Mood and Quality of Life as measured by CGI-S survey

  36 months

• Effect of DBS on Mood and Quality of Life as measured by MMSE tool

  36 months

Study Arms (3)

Sham Control stimulation, then Therapeutic stimulation

EXPERIMENTAL

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.

Device: Medtronic Percept Deep Brain Stimulation Therapy [Sham Control Stimulation]; Device: Medtronic Percept Deep Brain Stimulation Therapy [Therapeutic stimulation]

Therapeutic stimulation, then Sham Control stimulation

EXPERIMENTAL

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.

Device: Medtronic Percept Deep Brain Stimulation Therapy [Sham Control Stimulation]; Device: Medtronic Percept Deep Brain Stimulation Therapy [Therapeutic stimulation]

Therapeutic stimulation

EXPERIMENTAL

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

Device: Medtronic Percept Deep Brain Stimulation Therapy [Therapeutic stimulation]

Interventions

Medtronic Percept Deep Brain Stimulation Therapy [Sham Control Stimulation] DEVICE

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

Sham Control stimulation, then Therapeutic stimulation; Therapeutic stimulation, then Sham Control stimulation

Medtronic Percept Deep Brain Stimulation Therapy [Therapeutic stimulation] DEVICE

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. Therapeutic Stimulation= DBS ON

Sham Control stimulation, then Therapeutic stimulation; Therapeutic stimulation; Therapeutic stimulation, then Sham Control stimulation

Eligibility Criteria

• Age: 22 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nader Pouratian: lead

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Nader Pouratian, M.D., Ph.D.

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

2146486630; Nader.Pouratian@UTSouthwestern.edu

Tash Mupambo

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Neither the participant of investigator will know which treatment group an individual is assigned to. After the completion of the blinded portion of the trial, all participants will be transitioned to open-label stimulation/treatment.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor and Chair

Model Details: There will be two 4 month blocks in which, depending on group assignment, participants will receive either active or sham stimulation from the DBS device. Following completing of the first 4 month block, the groups will cross-over. Individuals originally receiving active stimulation will now receive sham, and individuals receiving sham stimulation originally will now receive active stimulation. Following the completing of both four month blocks, all participants will receive active open-label treatment. Continued follow-up psychiatric assessments will be preformed every two week during the double-blind portion of the trial, and then every 6 weeks during the open-label treatment phase.

Study Record Dates

• First Submitted: October 5, 2024
• First Posted: October 28, 2024
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): January 1, 2031
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)