Recruiting

Cortical Stimulation

Sponsor:

Andrew Moses Lee, MD, PhD

Code:

NCT04958096

Conditions

Obsessive-Compulsive Disorder

Eligibility Criteria

Sex: All

Age: 22 - 70+

Healthy Volunteers: Not accepted

Interventions

Standard Therapeutic Deep Brain Stimulation

Cortical Stimulation for PFC

Cortical Stimulation for ACC

Study Details

Brief summary:

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.

Conditions

Obsessive-Compulsive Disorder

Study ID

NCT04958096

Start date

Aug 1, 2021

Status verified date

Apr, 2026

Completion date

Aug 1, 2026

Anticipated

Primary completion date

Aug 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Ability to give informed consent for the study
  • Age 22-75
  • Clinical diagnosis of OCD
  • Documented duration of OCD of at least 5 years
  • OCD rated as severe or extreme illness (YBOCs ≥ 28)
  • Has failed to improve following treatment with at least two selective serotonin reuptake inhibitors (SSRIs), clomipramine, and augmentation with antipsychotics
  • Has not responded to adequate trials of cognitive behavior therapy (exposure and response prevention)
  • Has not responded adequately to TMS treatment for OCD if it is reasonably available to the patient

Exclusion Criteria:

  • Has hoarding as a primary subclassification of OCD according to DSM-4
  • Has another severe psychiatric disorder (personality disorder, psychotic/bipolar disorder, etc) or substance abuse issues
  • Is pregnant
  • Has an abnormal MRI assessed by the team or has a neurological condition requiring an MRI in the future
  • Has a cognitive disorder or dementia
  • Is at imminent risk for suicide based upon Suicide Severity Rating Scale (SSRS) or has ever attempted suicide
  • Inability to comply with study follow-up visits
  • Major comorbidity increasing the risk of surgery (prior stroke, severe hypertension, severe diabetes, or need for chronic anticoagulation other than aspirin)
  • Allergies or known hypersensitivity to materials in the Activa systems (i.e. titanium, polyurethane, silicone, polyethermide, stainless steel).
  • Previous cranial ablative or deep brain stimulation surgery.
  • Patients may be excluded from enrollment due to a condition that, in the judgement of the PI, significantly increases risk or reduces significantly the likelihood of benefit from DBS.

Study Design

Enrollment

15 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

Standard Therapeutic Deep Brain Stimulation

DBS to the standard subcortical targets (anterior limb of the internal capsule- ALIC) will be used to treat OCD

Cortical Stimulation for PFC

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

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

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 and Locations

Central contacts

Andrew M Lee, MD, PhD

415-502-5472ocdresearch@ucsf.edu

Tenzin Norbu, BS

415-514-6489ocdresearch@ucsf.edu

Locations

UCSF Nancy Friend Pritzker Psychiatry Building

Recruiting

San Francisco, California, United States, 94107

Contacts

Andrew M Lee, MD, PhD

415-502-5472ocdresearch@ucsf.edu

Tenzin Norbu, BS

415-514-6489ocdresearch@ucsf.edu

Principal Investigator:

Andrew M Lee, MD, PhD

More Information

Sponsor

Andrew Moses Lee, MD, PhD

Last update posted

May 1, 2026

Last verified

Apr, 2026

Keywords

  • OCD
  • Obsessive Compulsive Disorder
  • Obsessive thoughts
  • Compulsions

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Andrew Moses Lee, MD, PhD on 2026-05-01.