NCT04958096

Cortical Stimulation to Treat Obsessive Compulsive Disorder

Recruiting now NA Last updated 27 March 2025

What this trial tests

NA trial testing Standard Therapeutic Deep Brain Stimulation in Obsessive-Compulsive Disorder in 15 participants. Currently enrolling.

Timeline

1 August 2021

Primary endpoint
1 August 2026

1 August 2026

Quick facts

Lead sponsor	Andrew Moses Lee, MD, PhD
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	15
Start date	1 August 2021
Primary completion	1 August 2026
Estimated completion	1 August 2026
Sites	1 location across United States

Drugs / interventions tested

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

Conditions studied

• Obsessive-Compulsive Disorder — all drugs for Obsessive-Compulsive Disorder →

Sponsor

Andrew Moses Lee, MD, PhD

Who can join

Adults 22 to 75, any sex, with Obsessive-Compulsive Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Deep Brain Stimulation for the Management of Refractory Neurological Disorders: A Comprehensive Review.
   Rissardo JP, Vora NM, Tariq I, Mujtaba A, et al · · 2023 · cited 17× · PMID 38004040 · DOI 10.3390/medicina59111991
2. Best practices for clinical trials of deep brain stimulation for neuropsychiatric indications.
   Tremblay-McGaw AG, Hamlat EJ, Becker NC, Astudillo Maya DA, et al · · 2025 · cited 1× · PMID 40309667 · DOI 10.3389/fnhum.2025.1572972