RECRUITING

Cortical Stimulation to Treat Obsessive Compulsive Disorder

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Adjunct Cortical Stimulation With Deep Brain Stimulation (DBS) to Treat Obsessive Compulsive Disorder (OCD)

Quick Facts

Study Start:2021-08-01
Study Completion:2026-08-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04958096

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Ability to give informed consent for the study
  2. * Age 22-75
  3. * Clinical diagnosis of OCD
  4. * Documented duration of OCD of at least 5 years
  5. * OCD rated as severe or extreme illness (YBOCs ≥ 28)
  6. * Has failed to improve following treatment with at least two selective serotonin reuptake inhibitors (SSRIs), clomipramine, and augmentation with antipsychotics
  7. * Has not responded to adequate trials of cognitive behavior therapy (exposure and response prevention)
  8. * Has not responded adequately to TMS treatment for OCD if it is reasonably available to the patient
  1. * Has hoarding as a primary subclassification of OCD according to DSM-4
  2. * Has another severe psychiatric disorder (personality disorder, psychotic/bipolar disorder, etc) or substance abuse issues
  3. * Is pregnant
  4. * Has an abnormal MRI assessed by the team or has a neurological condition requiring an MRI in the future
  5. * Has a cognitive disorder or dementia
  6. * Is at imminent risk for suicide based upon Suicide Severity Rating Scale (SSRS) or has ever attempted suicide
  7. * Inability to comply with study follow-up visits
  8. * Major comorbidity increasing the risk of surgery (prior stroke, severe hypertension, severe diabetes, or need for chronic anticoagulation other than aspirin)
  9. * Allergies or known hypersensitivity to materials in the Activa systems (i.e. titanium, polyurethane, silicone, polyethermide, stainless steel).
  10. * Previous cranial ablative or deep brain stimulation surgery.
  11. * 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.

Contacts and Locations

Study Contact

Andrew M Lee, MD, PhD
CONTACT
415-502-5472
ocdresearch@ucsf.edu
Tenzin Norbu, BS
CONTACT
415-514-6489
ocdresearch@ucsf.edu

Principal Investigator

Andrew M Lee, MD, PhD
PRINCIPAL_INVESTIGATOR
University of California, San Francisco

Study Locations (Sites)

UCSF Nancy Friend Pritzker Psychiatry Building
San Francisco, California, 94107
United States

Collaborators and Investigators

Sponsor: Andrew Moses Lee, MD, PhD

  • Andrew M Lee, MD, PhD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-08-01
Study Completion Date2026-08-01

Study Record Updates

Study Start Date2021-08-01
Study Completion Date2026-08-01

Terms related to this study

Keywords Provided by Researchers

  • OCD
  • Obsessive Compulsive Disorder
  • Obsessive thoughts
  • Compulsions

Additional Relevant MeSH Terms

  • Obsessive-Compulsive Disorder