ClinicalTrials.gov Identifier: NCT06347978

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.

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.

The purpose of this study is to determine if personalized deep brain stimulation (DBS) based upon invasive brain mapping is safe and can lead to better outcomes.

The information we obtain in this study will be used to better understand the parts of the brain involved in Obsessive Compulsive Disorder (OCD).

We are looking for a total of 10 adult patients with treatment-refractory OCD. This study will be conducted in three stages, including implantation of SEEG depth electrodes for brain mapping, placement of the DBS system, and a randomized, shamcontrolled crossover trial, followed by open label treatment.

Please email [email protected] if you are interested in participating or have any questions about the study.

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