Early Feasibility Study of Sensing-enabled Ventral Capsule Deep Brain Stimulation in 10 Participants with Intractable...

To address the limitations of current trial-and-error programming strategies in deep brain stimulation (DBS) for refractory obsessive-compulsive disorder (OCD), we implanted patients with sensing-capable DBS devices to identify neural biomarkers that could provide objective feedback to the clinician about therapeutic efficacy.

We conducted an early feasibility study in 10 patients with severe, treatment-resistant OCD. All subjects received bilateral DBS leads targeting the ventral internal capsule (VC) and the second half of the cohort also received strip electrodes over the bilateral orbitofrontal cortex for recording only. All leads were connected to investigational, bidirectional DBS devices. After implantation, participants returned for scheduled programming visits to determine optimal stimulation parameters (Phase 1). In Phase 2, patients completed a course of exposure and response prevention (ERP) psychotherapy, and in Phase 3, patients underwent a double-blind discontinuation of DBS to test true vs. sham response. Phase 4 was an open-label follow-up. We administered standardized symptom scales throughout the study and used non-parametric repeated-measures analyses to analyze neuropsychological data.

All patients elected to resume stimulation after a discontinuation phase. At the end of the study, the mean reduction in the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) was 22 points or 60% across all patients with 8 patients demonstrating full response ( > 35% decrease in Y-BOCS). All participants also experienced reduced depression severity.

In patients with refractory OCD, we demonstrate excellent clinical response to VC DBS. We show feasibility of recording neural data both at home and in the clinic on board bidirectional DBS devices.