Deep Brain Stimulation for Refractory Obsessive-Compulsive Disorder
Key facts
- Who runs it
- Nader Pouratian
- Where
- Dallas, United StatesSee the site
- Trial code
- Status
- Recruiting
- People taking part
- 10 people, planned
- Started
- Nov 2026
- Expected to end
- Jan 2031
- Type of study
- Interventional, 3 groups
- Treatments tested
- Medtronic Percept Deep Brain Stimulation Therapy [Sham Control Stimulation]
- Medtronic Percept Deep Brain Stimulation Therapy [Therapeutic stimulation]
- Record updated
- 1 October 2026
Who can take part
- Age
- 22 years to 75 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 16 criteriaShow less
Who can take part
- 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
Who cannot take part
- Any clinically significant abnormality on preoperative MRI that would affect the safety of the surgical procedure in the opinion of the study neurosurgeon
- Diagnosis of severe major depression disorder (MDD) with psychotic features
- 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
- Any other current clinical significant neurological disorder or medical illness affecting brain function, other than a tic disorder
- Any DBS contraindication, infection, coagulopathy, significant cardiac risk factors, or other medical risk factors for surgery
- Significant suicidal risk [Hamilton Depression scale item 3 (suicide)>2]
- Significant cognitive decline, measured by Mini-Mental State Examination (MMSE <26) and Montreal Cognitive Assessment (MoCA; <24)
- Pregnancy
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 22 and 75 years old?
Where in United States
- University of Texas Southwestern Medical CenterDallas, United StatesContact: Nader Pouratian, M.D., Ph.D.Taking people
About the trial
What the trial wants to find out
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:
Read full original descriptionShow less
* 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
The 3 groups in the trial
- Sham Control stimulation, then Therapeutic stimulationTreatment being tested
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.
Treatment: Medtronic Percept Deep Brain Stimulation Therapy [Sham Control Stimulation] and Medtronic Percept Deep Brain Stimulation Therapy [Therapeutic stimulation]
- Therapeutic stimulation, then Sham Control stimulationTreatment being tested
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.
Treatment: Medtronic Percept Deep Brain Stimulation Therapy [Sham Control Stimulation] and Medtronic Percept Deep Brain Stimulation Therapy [Therapeutic stimulation]
- Therapeutic stimulationTreatment being tested
All participants will transition to an open label stimulation phase for chronic therapy after the cross-over portion of this trial
Treatment: Medtronic Percept Deep Brain Stimulation Therapy [Therapeutic stimulation]
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Towards Closed Loop Deep Brain Stimulation for Treatment of Refractory Obsessive-Compulsive Disorder
- Fit questions
- Built from NCT06660225, who can take part
- Record updated
- 1 October 2026