Deep Brain Stimulation for Refractory Obsessive-Compulsive Disorder

Part of paid clinical trials in Dallas, Texas.

Sponsor
Nader Pouratian
Study ID
NCT06660225
Status
Recruiting
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Conditions

  • Obsessive-Compulsive Disorder

Eligibility Criteria

Sex
ALL
Age
22 Years - 75 Years
Healthy Volunteers
Not accepted

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
  • 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

Study Details

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

Key Dates

Start date
Jun 30, 2026
Status verified
Apr 2026
Primary completion
Sep 30, 2029
Completion
Jan 31, 2031

Study Design

Enrollment
10 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

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

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas Southwestern Medical CenterDallasTexas75390
Nader Pouratian, M.D., Ph.D.
[email protected]
310/274-2095
Kala Bailey, M.D. (SUB_INVESTIGATOR)
Nader Pouratian, M.D., Ph.D. (PRINCIPAL_INVESTIGATOR)

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By research site
University of Texas Southwestern Medical Center· Dallas, TX

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