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)

This dual-site, double-blinded, randomized, sham-controlled, crossover study is to assess the safety, feasibility, and preliminary efficacy of SEEG-guided multi-lead DBS in 10 participants suffering from severe symptoms of chronic, treatment-refractory OCD. Stage 1: Invasive SEEG Monitoring and Recovery Goal: To perform stimulation mapping studies and SEEG recordings, that aid in the identification of candidate DBS targets, and to optimize stimulation parameters To identify stimulation sites that lead to improvement in symptoms of OCD and related symptoms To identify neural activity patterns, that correlate with OCD symptoms, by performing SEEG recordings across regions implicated in OCD during spontaneous and provoked conditions Stage 2: SEEG-guided DBS Implantation and Optimization of DBS Programming Goal: To use data collected from the SEEG monitoring stage to guide DBS targeting and the design of putative stimulation parameters To implant DBS electrodes in the optimal targets identified during the SEEG Intracranial Monitoring phase To perform DBS programming, in which stimulation parameters are systematically changed in different nodes of the frontostriatal network, to optimally relieve OCD symptoms by entraining the most relevant circuit Stage 3: Randomized Sham-controlled Crossover Trial Goal: To assess the feasibility, safety, and preliminary efficacy of SEEG-guided multi-lead DBS Feasibility: To assess feasibility of an SEEG-guided 4-lead DBS approach to treating chronic, severe, treatment-refractory OCD Safety: To monitor the rate of severe adverse events in comparison to comparable DBS studies in OCD Preliminary Efficacy: To assess the change in OCD severity, as measured by the difference in Y-BOCS II score, with active stimulation compared with sham stimulation Clinical Measures Y-BOCS II: OCD severity will be assessed utilizing this scale at two baseline visits. Y-BOCS II will be utilized as our primary outcome variable in stage 3 to assess the efficacy of our SEEG-guided 4-lead DBS paradigm. It is a commonly used, well-validated instrument chosen because of its frequent use in measuring changes in OCD severity in clinical trials. Secondary measures to characterize response to 4-lead DBS include the following well-validated scales: Y-BOCS I, Obsessive-Compulsive Inventory (OCI), Montgomery and Asberg Depression Rating Scale (MADRS), Structured Hamilton-A, Visual Analogue Scales (OCD, Depression, Anxiety, Energy), PGIC, Global Assessment of Functioning Scale (GAF), and CGI-I. Other clinical measures include the following scales: C-SSRS, Modified Scale for Suicidal Ideation (MSSI), YMRS, Generalized Anxiety Disorder-7 (GAD-7), MINI+SCID (Structured Clinical Interview for DSM Disorders), SCID-II, and AIMS. Efficacy Stage 3: The primary efficacy outcome measure is the change in Y-BOCS II scores measured using a general linear model with repeated measures where Y-BOCS II is the dependent variable and period order and treatment (sham/active stimulation) as the independent variables to examine the effect of DBS therapy on OCD. We will also evaluate the significance of the interaction between the period effect and treatment to examine if the period effect is modified by treatment. As our secondary outcome, we will assess the proportion of subjects who are responders based on 35% reduction of baseline Y-BOCS I and II scores. A Statistical Analysis Plan will include a comprehensive description of the statistical methods and reports to be included in the final study report. Results, per patient, will be described using standard summary statistics, including evaluating outcomes at each visit and assessing changes from baseline before and after invasive surgeries and stimulation.

You may be eligible for this study if you meet the following criteria:

• Conditions:
  Medical Research
• Age: Between 22 Years - 75 Years
• Gender: All