Health Trials

SEEG-Guided DBS for OCD

ConditionObsessive-Compulsive Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-75
SponsorCasey H. Halpern, M.D.

About this trial

This is a multi-site, double-blinded, randomized, crossover study design for SEEG-guided 4-lead DBS for treatment-refractory OCD, followed by open-label stimulation for an additional 6 months. The study will be conducted in 3 stages: Stage 1 will consist of SEEG brain mapping and optimization of stimulation parameters. Stage 2 will consist of DBS surgery and further optimization of stimulation parameters. Stage 3 will be randomized, crossover treatment, followed by open-label treatment.

Eligibility criteria

Qualifiers

≥ 22 years and ≤ 75 years of age, at the time of screening

Chronic (> five years preceding the date of enrollment) OCD, diagnosed as per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition guidelines (DSM-5)

Presence of obsessions, compulsions, or both

Time-consuming obsessions and compulsions that take more than one hour a day or cause clinically significant distress or impairment in social, occupational, or other important areas of functioning

Disqualifiers

Diagnosis of, according to the Mini International Neuropsychiatric Interview (MINI), any other primary psychiatric diagnosis defined in the DSM-5, including Hoarding Disorder.

In the opinion of the PI and relative to the date of enrollment, (a) current or past diagnosis of, or medical history/records suggestive of, a DSM-5 defined Personality Disorder, considered to be severe; or (b) history of hospitalization because of Borderline Personality Disorder

High suicide risk, as determined by the Columbia Suicide Severity Rating Scale (C-SSRS) along with clinician assessment; or

A suicide attempt within the past twelve months that led to hospitalization; or

Trial design

Treatments tested in this trial

  • Stereoencephalography (SEEG)
  • Deep Brain Stimulation (DBS)

Treatment groups

12 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Casey H. Halpern, M.D.

Lead sponsor

University of Pennsylvania

Sponsor institution

Stanford University

Collaborator

University of Pennsylvania

Collaborator

Mayo Clinic

Collaborator

Boston Scientific Corporation

Collaborator

Medtronic

Collaborator

Source ClinicalTrials.gov