Cortical Stimulation to Treat Obsessive Compulsive Disorder

StatusActive, Not Recruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 2 years later Aug 1, 2026 → Aug 1, 2028
See other at-risk trials from Andrew Moses Lee, MD, PhD

Record History

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  1. Notable Primary and study completion pushed from Aug 1, 2026 to Aug 1, 2028 Show 5 more changesShow less
    • Enrollment closed, study ongoing
    • Eligibility criteria expanded, about 19 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Site details revised
    • Publications: details revised at 28 of 28 entries
  2. Minor 3 versions Re-verified since Jan 3, 2024, no change to tracked fieldsv4-v6
  3. Minor Study site revisedv3
  4. Minor Primary and study completion dates: Aug 2026 to Aug 1, 2026
    • Start date changed from estimate of Aug 2021 to Aug 1, 2021
    • Site contact updated
    v2
  5. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04958096
Lead Sponsor Andrew Moses Lee, MD, PhD
Conditions
(from sponsor)
Obsessive-Compulsive Disorder
Related terms Compulsive Behavior, Obsessive-Compulsive Disorder
Enrollment 15 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov