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NCT04958096 · ClinicalTrials.gov registry record · NA
Cortical Stimulation to Treat Obsessive Compulsive Disorder
A NA study of Obsessive - Compulsive Disorder, sponsored by Andrew Moses Lee, MD, PhD.
- Recruiting
- Registry status
- NA
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT04958096: Recruiting NA study of Obsessive - Compulsive Disorder, sponsored by Andrew Moses Lee, MD, PhD.
NCT04958096 is a NA study of Obsessive - Compulsive Disorder that is actively recruiting participants, run by Andrew Moses Lee, MD, PhD. The registered enrollment target is 15 participants, below the 2,064-participant average among 84 other Obsessive - Compulsive Disorder trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04958096, a NA study of Obsessive - Compulsive Disorder, is actively recruiting participants, sponsored by Andrew Moses Lee, MD, PhD.
- RECRUITING
- Registry status
- NA
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
The Y-BOCS is an OCD symptom scale used for identifying current OCD symptom severity. The score ranges from 0-40, with higher scores indicating more severe OCD symptoms. The change in Y-BOCS score from 12 months to 24 months will be reported.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2021-08-01 |
| Est. Completion | 2026-08-01 |
| Phase | NA |
What NCT04958096 shows while recruiting
NCT04958096 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 2,064-participant average among 84 other Obsessive - Compulsive Disorder trials with a reported enrollment target (99% lower).
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.
NCT04958096 reports a single indexed study location in California.
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.
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).
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.
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.
Learn More About Clinical Trials
Similar trials for Obsessive - Compulsive Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04958096's enrollment target sits among peer trials
15 74th of 84 higher than 11 of 84 other Obsessive - Compulsive Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obsessive - Compulsive Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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