Connectomic Deep Brain Stimulation for Obsessive Compulsive Disorder
- Conditions
- Obsessive Compulsive Disorder (OCD)
- Interventions
- Device: Selective focal stimulation of ALIC-pathways
- Registration Number
- NCT05160129
- Lead Sponsor
- Icahn School of Medicine at Mount Sinai
- Brief Summary
Deep brain stimulation (DBS) is an effective treatment for people suffering from severe obsessive-compulsive disorder (OCD) whose symptoms have failed to improve after years and multiple methods of intervention. An effective DBS target for OCD is the anterior limb of the internal capsule (ALIC) brain region. On average 60% of all OCD patients have a clinically significant response to ALIC DBS. However, ALIC DBS may become even more effective with the ability to predict which specific ALIC connections in the brain need to be stimulated for each individual OCD patient. This study therefore investigates personalized stimulation to the ALIC that allows for precise modulation of brain circuits associated with individual OCD symptoms. The study aims to specify the ideal anatomical target for ALIC DBS for maximum therapeutic benefit in each patient.
- Detailed Description
To improve DBS for severe OCD, the anatomical specificity with which stimulation is delivered must be enhanced. In this study, patients will receive personalized and circuit specific stimulation to five target ALIC pathways based on pre-surgery brain scan analysis where patient-specific blueprints are created and used to determine implant location. Stimulation to the ALIC is delivered by directional segmented electrodes which are designed to deliver precise activation of circuits of interest and minimize excess tissue activation that can cause side effects. In this study, ALIC DBS will target white matter pathways, each having different cortical projections that affect different behavioral outputs, instead of traditional targeting. Each of these chosen pathways have been shown to be involved in the effects of ALIC DBS for OCD, but the results vary between studies.
The current study involves routine implantation of bilateral DBS leads into the ALIC brain region, which are connected to an internal pulse generator (IPG) device that is implanted under the skin near the collar bone and controls stimulation delivery. Before surgery, patients will receive a high definition 7T MRI brain scan to carefully plan the personalized lead implantation. Following surgery, patients will receive routine clinical visits for optimizing the DBS parameters and monitoring of clinical effects. As part of this study, patients will participate in EEG recordings at stimulation initiation and after 6 and 12 months. In addition, patients will complete behavioral paradigm testing bimonthly during stimulation of circuit-specific DBS contacts.
The goal of this study is to create a blueprint map of the brain that characterizes pathways that are found in effective treatment of OCD. This will be done by determining which pathways are activated by stimulation in different locations in ALIC and linking these locations with changes in task performance. This will allow for specification of the ideal anatomical target for DBS for OCD for maximum therapeutic benefit.
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 20
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Circuit-selective DBS Selective focal stimulation of ALIC-pathways People suffering from severe obsessive-compulsive disorder (OCD)
- Primary Outcome Measures
Name Time Method Change in Yale Brown Obsessive Compulsive Scale (Y-BOCS) Pre-surgical baseline, monthly up to 12 months postoperative This scale measures change in OCD symptom severity. Full scale from from 0 - 40 with higher score indicating more severe symptoms.
- Secondary Outcome Measures
Name Time Method Reversal Task Pre-surgical baseline, bimonthly up to 12 months postoperative This computational reversal task provides a measure of cognitive flexibility under conditions of uncertainty.
Computational computer tasks: These behavioral tasks provide a measure of reward valuation, cognitive flexibility under conditions of uncertainty, and a measure of inhibitory control.Change in Beck Depression Inventory (BDI) Pre-surgical baseline, monthly up to 12 months postoperative This scale indicates the presence and severity of depressive symptoms. Full scale from 0 to 63 , with higher score indicating more severe depression.
Tractography pathway activation models (Diffusion-weighted-imaging) Baseline: Pre-surgery Data collected from MRI scans will be used to measure structural connectivity in the brain (i.e., white matter pathways) that is used for surgical planning.
Deep brain stimulation evoked potentials (EEG) postoperative months 0, 6, 12 Evoked potentials provide a measure of electrophysiological, effective connectivity in the brain. Alpha, beta, theta, gamma and delta bandwidths will be assessed.
Change in Beck Anxiety Inventory (BAI) Pre-surgical baseline, monthly up to 12 months postoperative This scale measures severity of anxiety symptoms. Full scale from 0 to 63, with higher score indicating more severe anxiety.
Investment Task Pre-surgical baseline, bimonthly up to 12 months postoperative This computational investment task provides a measure of reward valuation by measuring decision making related to different reward conditions.
Computational computer tasks: These behavioral tasks provide a measure of reward valuation, cognitive flexibility under conditions of uncertainty, and a measure of inhibitory control.Change in Young Mania Rating Scale (YMRS) Pre-surgical baseline, monthly up to 12 months postoperative This scale measures the presence and severity of mania. Full scale from 0 - 60, with higher scores indicating more severe mania.
Stop Signal Task Pre-surgical baseline, bimonthly up to 12 months postoperative This computational stop signal task provides a measure of inhibitory control by assessing stop-signal reaction time.
Computational computer tasks: These behavioral tasks provide a measure of reward valuation, cognitive flexibility under conditions of uncertainty, and a measure of inhibitory control.Change in Barratt Impulsiveness Scale (BIS-11) Pre-surgical baseline, monthly up to 12 months postoperative This is a clinical measure of impulsivity. Full scale from 30 -120, with a higher score indicating greater impulsivity.
Change in Columbia-Suicide Severity Rating Scale (C-SSRS) Pre-surgical baseline, monthly up to 12 months postoperative This scale measures risk of suicide on multiple dimensions, scored by answering "yes or no" questions where answers of "yes" may indicate risk. Full range from 0 to 9, with higher score indicating higher intensity suicidal ideation.
Trial Locations
- Locations (1)
Mount Sinai West
🇺🇸New York, New York, United States