Cortical Stimulation to Treat Obsessive Compulsive Disorder

Part of paid clinical trials in San Francisco, California.

Sponsor
Andrew Moses Lee, MD, PhD
Study ID
NCT04958096
Status
Recruiting
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Conditions

  • Obsessive-Compulsive Disorder

Eligibility Criteria

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

Interventions

  • Standard Therapeutic Deep Brain Stimulation — DEVICE
    DBS to the standard subcortical targets (anterior limb of the internal capsule- ALIC) will be used to treat OCD
  • Cortical Stimulation for PFC — DEVICE
    Patients enrolled in this study will have a second pair of leads placed in the prefrontal cortex (PFC) bilaterally as well the surrounding white matter tracts and stimulation will be delivered through these leads to improve OCD symptoms
  • Cortical Stimulation for ACC — DEVICE
    Patients enrolled in this study will have a second pair of leads placed in the anterior cingulate cortex (ACC) bilaterally as well the surrounding white matter tracts and stimulation will be delivered through these leads to improve OCD symptoms

Study Details

The purpose of this study is to identify abnormal brain signals associated with Obsessive Compulsive Disorder (OCD) and psychiatric symptoms and to investigate novel therapeutic stimulation sites. While treating OCD with standard deep brain stimulation (DBS) therapy, the investigators will also monitor the activity of the anterior cingulate and prefrontal cortex, a region known be involved with OCD, decision making, and emotion regulation, and the investigators will identify abnormal activity corresponding to the severity of a patient's OCD. The investigators will also investigate whether it is possible for stimulation delivered to these parts of the brain can improve OCD symptoms. These investigations have the potential to aid in the development of improved forms of DBS that can better target abnormal OCD brain signatures in the future. The investigators will implant a cortical electrode in addition to the ALIC DBS electrode and connect these to an implantable pulse generator that care store field potential data (Medtronic Percept). The decision whether the lead is placed in the prefrontal or cingulate cortex bilaterally will be based upon considerations of the surgical risks for a particular patient based upon their anatomy and the required surgical approach. At multiple time points post-implantation up to 2 years, in our clinic or patient's homes, cortical and subcortical signals will be recorded. Data will be collected while patient are resting or engaged in symptom provocation tasks, emotional/cognitive tasks while cortical stimulation is on and off. In addition to brain signal recordings, symptoms will be assessed using validated questionnaires and tasks to allow identification of neurophysiological correlates of OCD symptoms.

Key Dates

Start date
Aug 1, 2021
Status verified
Apr 2026
Primary completion
Aug 1, 2026
Completion
Aug 1, 2026

Study Design

Enrollment
15 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Prefrontal Cortex (PFC)
    The Prefrontal Cortex (PFC) treatment group will be have an implant bilaterally at the HDE-approved ALIC site and the PFC.
  • Experimental: Anterior Cingulate Cortex (ACC)
    The Anterior Cingulate Cortex (ACC) treatment group will be have an implant bilaterally at the HDE-approved ALIC site and the ACC.

Primary Outcome Measure

Change in Yale-Brown Obsessive Compulsive Scale (Y-BOCS) from 12 months to 24 months [ Time Frame: 12-24 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UCSF Nancy Friend Pritzker Psychiatry BuildingSan FranciscoCalifornia94107
Andrew M Lee, MD, PhD
[email protected]
415-502-5472
Tenzin Norbu, BS
[email protected]
415-514-6489
Andrew M Lee, MD, PhD (PRINCIPAL_INVESTIGATOR)
Tenzin Norbu, BS (SUB_INVESTIGATOR)

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By research site
UCSF Nancy Friend Pritzker Psychiatry Building· San Francisco, CA

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