Personalized deep brain stimulation of the anterior limb of the internal capsule for OCD
Connectomic Deep Brain Stimulation for Obsessive Compulsive Disorder
This study tests whether tailoring deep brain stimulation to each person's specific ALIC brain connections can help adults with severe, treatment‑resistant OCD.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05160129 on ClinicalTrials.gov |
What this trial studies
Participants undergo high‑resolution (7T) MRI to create patient‑specific connectomic blueprints that guide implantation location in the anterior limb of the internal capsule (ALIC). Bilateral directional segmented DBS leads are implanted and connected to an internal pulse generator to enable focused stimulation of five predefined ALIC white‑matter pathways. Stimulation settings are optimized in routine clinical visits to target circuits linked to each patient's symptoms while minimizing off‑target activation. EEG recordings are collected at stimulation initiation and during follow‑up to monitor circuit effects and clinical response.
Who should consider this trial
Good fit: Adults (18+) with primary DSM‑5 OCD who meet the FDA HDE criteria for ALIC DBS, have a minimum five‑year history of treatment‑refractory OCD (including failure of multiple SSRIs), and have elected to receive directional ALIC DBS are the intended candidates.
Not a fit: Patients with less severe or non‑treatment‑resistant OCD, those who are not surgical candidates, or those unwilling/unable to undergo preoperative 7T MRI and follow‑up visits are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could increase symptom relief by directing stimulation to the specific ALIC pathways most relevant to each patient's OCD.
How similar studies have performed: Previous ALIC DBS studies report roughly a 60% average clinical response, but individualized connectomic targeting is a newer approach with promising but not yet definitive evidence of improved outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
All participants will receive ALIC DBS for OCD. DBS received a Humanitarian Device Exemption (HDE) in 2009 with an indication for bilateral stimulation of the ALIC as an adjunctive treatment to medications and as an alternative to anterior capsulotomy for treatment of chronic, severe, treatment-refractory OCD in adult patients who have failed at least three SSRIs. Additionally, more stringent criteria have been selected for defining treatment-resistance in this protocol, as indicated below. INCLUSION CRITERIA: * 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 * Minimum of a five-year history of treatment-refractory OCD with substantial functional impairment * Failure of an adequate trial of at least three of the following SSRIs: Fluoxetine, Fluvoxamine, Citalopram, Escitalopram, Sertraline, Paroxetine * Failure of an adequate trial of clomipramine * Failure of an adequate trial of one or more of the aforementioned antidepressants in combination with at least one of the following augmentation agents: Haloperidol, Risperidone, Olanzapine, Quetiapine, Ziprasidone, Aripiprazole * Failure of an adequate trial of Cognitive Behavioral Therapy (CBT), defined as 25 hours of documented exposure and response prevention (ERP) by an expert therapist * Minimum score of 25 on the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) at preoperative baseline * Ability to undergo preoperative MRI * English proficiency * Capacity to provide written informed consent * Willing and able to comply with all device operation and study-related procedures EXCLUSION CRITERIA: * 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 * Conditions requiring anticoagulant therapy which cannot be discontinued for the perioperative period, as required * Conditions requiring certain regular MRI scans or diathermy * Currently implanted with a cardiac pacemaker / defibrillator or other implanted electrical device which may interfere with DBS stimulator or the function of which may be impacted by its implantation, in the opinion of evaluating neurosurgeon * Other primary Axis I disorder or history of psychosis, such as schizophrenia, psychosis in the context of depressive or manic episode. * Current or past history within the 6 months prior to DBS implantation of substance abuse or dependence (excluding nicotine and caffeine) * Active suicidal ideation with intent, suicide attempt within the last six months, more than three suicide attempts within the last two years, or serious suicide risk as determined by the study psychiatrists * Axis II disorders which, in the opinion of the study psychiatrist, may increases the risk of DBS to participants or cause study non-compliance * Patients who lack the capacity to for proper device usage and maintenance, in the opinion of the research team * Women who are pregnant
Where this trial is running
New York, New York
- Mount Sinai West — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Martijn Figee — Icahn School of Medicine and Mount Sinai
- Study coordinator: Abby Kiros
- Email: abigeal.kiros@mssm.edu
- Phone: 212-523-8279
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.