NCT06347978

Personalized DBS for OCD Guided by Stereoencephalography Mapping

A Double-Blinded, Randomized, Crossover Trial of Stereoencephalography- Guided Four-Lead Personalized Deep Brain Stimulation for Treatment-Refractory Obsessive Compulsive Disorder (SEEG-Guided DBS for OCD)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Andrew Moses Lee, MD, PhD · Academic / Other
• Sex: All
• Age: 22 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a double-blinded, randomized, crossover study design for SEEG-guided 4-lead DBS for treatment-refractory OCD, followed by open label stimulation for an additional 6 months. The study will be conducted in 3 stages: Stage 1 will consist of SEEG brain mapping and optimization of stimulation parameters. Stage 2 will consist of 4-lead DBS surgery with bilateral IPGs and further optimization of stimulation parameters. Stage 3 will be randomized, crossover treatment, followed by open label treatment.

Detailed description

The study consists of 3 stages. In Stage 1, the investigators will implant SEEG depth electrodes into various components of the CSTC OCD circuit such as the OFC, ACC, VC/VS, BNST, and amSTN. The investigators will perform extensive stimulation mapping to identify anatomical sites and stimulation parameters that improve symptoms. The investigators also intend to record abnormal local field potential (LFP) activity during periods of varying intensities of spontaneous and provoked OCD symptom severity and will determine if therapeutic stimulation can normalize abnormal neural activity associated with OCD symptoms. In Stage 2, the investigators will use the information obtained during the SEEG Invasive Monitoring phase (Stage 1) to inform the placement of 4 DBS leads using the Medtronic Percept Implantable Pulse Generator system. DBS leads will be targeted to regions identified, in Stage 1, as being associated with symptomatic improvement and OCD-related neural activity. During this phase, the investigators will perform DBS programming to systematically change stimulation parameters to find parameters that optimally relieve patients' OCD symptoms. In Stage 3, the investigators will then carry out a randomized, controlled, crossover trial to assess the safety, feasibility, and initial efficacy of our SEEG-guided DBS approach for treatment-refractory OCD.

Conditions

• Obsessive-Compulsive Disorder
• OCD

Interventions

Type	Name	Description
DEVICE	Deep Brain Stimulation	Subjects will be randomized to either ON-OFF (Stimulation-Sham) or OFF-ON (Sham-Stimulation) arms. Patients in the ON-OFF arm will first be treated for up to 12 weeks with the parameters identified during the DBS optimization phase until the washout period. Patients in the OFF-ON will have their devices turned off and will not have their device switched on (activated) until the crossover point. After completion of the first phase of the trial, patients will undergo another washout phase until they are within 20% of their pre-treatment Y-BOCS II score or 4 weeks have passed, whichever comes first. The purpose of the washout is to eliminate any residual effect of stimulation in the ON group. Patients will then be advanced to the crossover phase. The participants who were initially randomized to the ON-OFF arm will be moved onto the sham (OFF) period, and the participants who were initially randomized to the OFF-ON group will be moved onto stimulation (ON) period for up to 12 weeks.

Timeline

• Start date: 2024-05-24
• Primary completion: 2028-05-01
• Completion: 2028-05-01
• First posted: 2024-04-04
• Last updated: 2025-04-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study