Stereo-encephalography-guided multi-lead deep brain stimulation for treatment-refractory obsessive compulsive disorder - study design and individualized surgical targeting approach.

INTRODUCTION

Treatment-refractory obsessive-compulsive disorder (trOCD) is a complex network disorder that may require personalized treatment strategies due to disease heterogeneity. A multi-site, multi-stage, double-blinded, randomized crossover clinical trial is underway, using stereo electroencephalography (sEEG) to guide selection of multi-nodal targets for deep brain stimulation (DBS) for trOCD.

OBJECTIVES

To describe the clinical trial design, emphasizing personalized surgical targeting strategies that ensure the feasibility and precision of sEEG electrode placement, and enable adequate sampling of relevant targets in trOCD for network evaluation and modulation.

METHODS

Adults with severe trOCD (Yale-Brown Obsessive Compulsive Scale ≥ 28) who meet eligibility criteria are enrolled in this three-stage clinical trial ( NCT05623306 ). Stage 1 involves SEEG electrode implantation in trOCD implicated regions and inpatient evaluation. Individualized probabilistic-tractography-guided target refinement is performed for surgical planning. Multimodal recordings are taken while participants stay in the psychiatric monitoring unit for 12 days. In stage 2, up to four permanent DBS electrodes are implanted followed by stimulation optimization. Stage 3 is the randomized, double blinded cross over phase.

EXPECTED OUTCOMES: Safety, feasibility and preliminary efficacy will be assessed in this ongoing study. We anticipate that the use of sEEG to guide selection of multi-nodal targets for DBS will be safe, feasible and result in clinically meaningful improvements in symptom severity and functional impairment in trOCD.

DISCUSSION: We present the clinical protocol of sEEG-guided investigation of brain networks involved in trOCD and describe our tractography-guided surgical targeting strategy designed to optimize individualized network engagement and neuromodulation.