About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years of age or older
Primary psychiatric diagnosis of Obsessive-Compulsive Disorder (OCD, per DSM-5 criteria)
Meets FDA Humanitarian Device Exemption (HDE) criteria for indication
Has elected to receive clinically indicated DBS for OCD with a directional system outside of this research study, as determined by treating clinician(s) and per current clinical practice
Disqualifiers
Ineligible or unwilling to receive ALIC DBS for OCD
Contraindications for general anesthesia, neurosurgery, or an MRI scan
Neurological disorder or other significant brain pathology, such as moderate / marked cerebral atrophy, stroke, tumor, epilepsy, or previous neurosurgical procedures (excluding cingulotomy, which may be permitted if not contraindicated in the opinion of implanting neurosurgeon)
Unstable medical illness, chronic immunosuppression, and/or considerably reduced life-expectancy
Trial design
Single group
Treatments tested in this trial
Selective focal stimulation of ALIC-pathways
DeviceDBS will be applied selectively to different electrode contacts/ segments to evaluate clinical, behavioral, and electrocortical responses of specific pathways within the ALIC.
Treatment groups
Trial outcomes
Primary outcomes
Change in Yale Brown Obsessive Compulsive Scale (Y-BOCS)
This scale measures change in OCD symptom severity. Full scale from from 0 - 40 with higher score indicating more severe symptoms.
Secondary outcomes
Investment Task
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.
Reversal Task
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.
Stop Signal Task
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.
Tractography pathway activation models (Diffusion-weighted-imaging)
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.
Sponsors and contacts
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Icahn School of Medicine at Mount Sinai
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator