NCT05623306

SEEG-Guided DBS for OCD

A Double-Blinded, Randomized, Crossover Trial of Stereoencephalography- Guided Multi-Lead 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: Katherine Scangos · Academic / Other
• Sex: All
• Age: 22 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-site, 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 DBS surgery and further optimization of stimulation parameters. Stage 3 will be randomized, crossover treatment, followed by open label treatment.

Conditions

• Obsessive-Compulsive Disorder

Interventions

Type	Name	Description
DEVICE	PMT Stereoencephalography (SEEG)	For Stage 1 of this study, we will be implanting depth electrodes to record stereoencephalography across a network of brain regions.
DEVICE	Vercise Genus™ Deep Brain Stimulation (DBS) System or Percept™ PC Neurostimulation System	For Stages 2 and 3 of this study, we intend to use the DBS system to treat patients with severe symptoms of chronic, treatment-refractory OCD by targeting stimulation to sites that have been determined to have therapeutic benefit during our SEEG Invasive Monitoring phase.

Timeline

• Start date: 2023-04-13
• Primary completion: 2028-03-01
• Completion: 2029-01-01
• First posted: 2022-11-21
• Last updated: 2026-04-06

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study