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RECRUITING NA

Cortical Stimulation to Treat Obsessive Compulsive Disorder

NCT04958096 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DEVICE Standard Therapeutic Deep Brain Stimulation
  • DEVICE Cortical Stimulation for PFC
  • DEVICE Cortical Stimulation for ACC

Study Locations (1)

California

  • UCSF Nancy Friend Pritzker Psychiatry Building — San Francisco

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2021-08-01
Est. Completion 2026-08-01
Phase NA

Sponsor

Andrew Moses Lee, MD, PhD

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04958096

The ClinicalTrials.gov registry entry for NCT04958096 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Andrew Moses Lee, MD, PhD, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Obsessive-Compulsive Disorder appearing as the primary indexed condition, and to 3 interventions — of which Standard Therapeutic Deep Brain Stimulation is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04958096 reports 1 study location spanning 1 distinct geographic area — top geographies include California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04958096 about?

NCT04958096 is a clinical study titled "Cortical Stimulation to Treat Obsessive Compulsive Disorder". 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 moni...

What is the current status of trial NCT04958096?

This trial is currently recruiting. It is a NA study. The enrollment target is 15 participants. The study started on 2021-08-01. Estimated completion is 2026-08-01.

What conditions does trial NCT04958096 study?

This clinical trial studies the following conditions: Obsessive-Compulsive Disorder. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04958096?

The interventions under investigation include: Standard Therapeutic Deep Brain Stimulation (DEVICE), Cortical Stimulation for PFC (DEVICE), Cortical Stimulation for ACC (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04958096?

This trial is sponsored by Andrew Moses Lee, MD, PhD, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04958096 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial