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Deep Brain Stimulation for Refractory Obsessive-Compulsive Disorder

NCT06660225 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-05-05

No results posted yet for this study

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

Interventions

DEVICE

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

DEVICE

Medtronic Percept Deep Brain Stimulation Therapy [Therapeutic 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. Therapeutic Stimulation= DBS ON

Sponsors & Collaborators

  • Nader Pouratian

    lead OTHER

Principal Investigators

  • Nader Pouratian, M.D., Ph.D. · University of Texas Southwestern Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
22 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2029-09-30
Completion
2031-01-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06660225 on ClinicalTrials.gov