Connectomic Deep Brain Stimulation for Obsessive Compulsive Disorder

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIcahn School of Medicine at Mount Sinai

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Selective focal stimulation of ALIC-pathways

    Device

    DBS will be applied selectively to different electrode contacts/ segments to evaluate clinical, behavioral, and electrocortical responses of specific pathways within the ALIC.

Treatment groups

22 Participants
are divided into 1 treatment group
Group A: Circuit-selective DBSExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Pre-surgical baseline, monthly up to 12 months postoperative

Secondary outcomes

1

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.

Time frame
Pre-surgical baseline, bimonthly up to 12 months postoperative
2

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.

Time frame
Pre-surgical baseline, bimonthly up to 12 months postoperative
3

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.

Time frame
Pre-surgical baseline, bimonthly up to 12 months postoperative
4

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.

Time frame
Baseline: Pre-surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Icahn School of Medicine at Mount Sinai

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator