SEEG-Guided DBS for OCD

Part of paid clinical trials in Stanford, California.

Sponsor
Casey H. Halpern, M.D.
Study ID
NCT05623306
Status
Recruiting
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Conditions

  • Obsessive-Compulsive Disorder

Eligibility Criteria

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

Interventions

  • Stereoencephalography (SEEG) — DEVICE
    For Stage 1 of this study, we will be implanting depth electrodes to record stereoencephalography across a network of brain regions.
  • Deep Brain Stimulation (DBS) — DEVICE
    For Stages 2 and 3 of this study, we intend to use the DBS system to treat patients with severe symptoms of chronic, treatment-refractory OCD by targeting stimulation to sites that have been determined to have therapeutic benefit during our SEEG Invasive Monitoring phase.

Study Details

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.

Key Dates

Start date
Apr 13, 2023
Status verified
May 2026
Primary completion
Apr 1, 2030
Completion
Apr 1, 2030

Study Design

Enrollment
12 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: ON-OFF (Stimulation-Sham)
    Participants randomized to the ON-OFF arm will receive active stimulation during the randomization phase for up to 12 weeks. The participants will then have their device turned off and receive sham stimulation during the crossover phase for up to 12 weeks.
  • Sham Comparator: OFF-ON (Sham-Stimulation)
    Participants randomized to the OFF-ON arm will have their device turned off and receive sham stimulation during the randomization phase for up to 12 weeks. The participants will then receive active stimulation during the crossover phase for up to 12 weeks.

Primary Outcome Measure

Primary Feasibility Endpoint #1 - OCD Relevant Network [ Time Frame: 14 days ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Stanford UniversityStanfordCalifornia94304-
University of PennsylvaniaPhiladelphiaPennsylvania19106
Neurosurgery Clinical Research Division
[email protected]
215-829-6720
Marie Kerr
[email protected]
215-829-6720

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By research site
Stanford University· Stanford, CAUniversity of Pennsylvania· Philadelphia, PA

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