Deep Brain Stimulation of the Anterior Cingulate Bundle (ACB) and the Ventral Anterior Limb of the Internal Capsule (vALIC) in Patients With Intractable Obsessive Compulsive Disorder (OCD)

NCT07303946 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 5POMH106435P52
• Study Type: interventional
• Target: 4
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a double blind pilot feasibility study, with a within subject crossover design of DBS of the anterior cingulate bundle(ACB) and the ventral anterior limb of the internal capsule(vALIC) in four patients with intractable OCD. Patients will be screened according to inclusion exclusion criteria listed above, approved by an independent Neuropsychiatric review board and informed consent obtained.

Conditions

Obsessive-Compulsive Disorder

Keywords

deep brain stimulation; intractable OCD

Outcome Measures

Primary Outcomes (6)

• Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)

  The Y-BOCS measures obsessive-compulsive symptom severity on a scale of 0-40. Higher scores indicate higher symptom severity (i.e., worse outcomes).

  At the final visit of Stage 1, which occurs at the end of 12 weeks of active stimulation of the first target.

• Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)

  The Y-BOCS measures obsessive-compulsive symptom severity on a scale of 0-40. Higher scores indicate higher symptom severity (i.e., worse outcomes).

  At the final visit of Stage 2, which occurs at the end of 12 weeks of active stimulation of the second target.

• Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)

  The Y-BOCS measures obsessive-compulsive symptom severity on a scale of 0-40. Higher scores indicate higher symptom severity (i.e., worse outcomes).

  At the final visit of Stage 3, which occurs at the end of 12 weeks of active stimulation of both targets.

• Clinical Global Impression (CGI)

  The CGI measures severity of illness and improvement in symptoms since enrollment. Items are each rated on a scale of 1-7. Higher scores indicate worse outcomes.

  At the final visit of Stage 1, which occurs at the end of 12 weeks of active stimulation of the first target.

• Clinical Global Impression (CGI)

  The CGI measures severity of illness and improvement in symptoms since enrollment. Items are each rated on a scale of 1-7. Higher scores indicate worse outcomes.

  At the final visit of Stage 2, which occurs at the end of 12 weeks of active stimulation of the second target.

• Clinical Global Impression (CGI)

  The CGI measures severity of illness and improvement in symptoms since enrollment. Items are each rated on a scale of 1-7. Higher scores indicate worse outcomes.

  At the final visit of Stage 3, which occurs at the end of 12 weeks of active stimulation of both targets.

Secondary Outcomes (6)

• Global Assessment of Functioning (GAF)

  At the final visit of Stage 1, which occurs at the end of 12 weeks of active stimulation of the first target.

• Global Assessment of Functioning (GAF)

  At the final visit of Stage 2, which occurs at the end of 12 weeks of active stimulation of the second target.

• Global Assessment of Functioning (GAF)

  At the final visit of Stage 3, which occurs at the end of 12 weeks of active stimulation of the both targets.

• Sheehan Disability Scale (SDS)

  At the final visit of Stage 1, which occurs at the end of 12 weeks of active stimulation of the first target.

• Sheehan Disability Scale (SDS)

  At the final visit of Stage 2, which occurs at the end of 12 weeks of active stimulation of the second target.

Study Arms (2)

ACB

EXPERIMENTAL

DBS of the anterior cingulate bundle (ACB)

Device: Medtronic Percept system and 3391 3387 Medtronic DBS electrodes

vALIC arms

EXPERIMENTAL

DBS of the ventral anterior limb of the internal capsule (vALIC)

Device: Medtronic Percept system and 3391 3387 Medtronic DBS electrodes

Interventions

Medtronic Percept system and 3391 3387 Medtronic DBS electrodes DEVICE

Surgical implantation of deep brain stimulation electrodes with stimulation at one of two intracranial targets depending on randomization and crossover status.

ACB; vALIC arms

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• OCD, diagnosed by Structured Clinical Interview for DSM-IV (SCID-IV), judged of disabling severity with a Yale-Brown Obsessive Compulsive Scale (YBOCS) score of at least 30 and a Global Assessment of Functioning (GAF) score of 45 or less.
• Persistence of severe symptoms and impairment for five or more years despite at least three adequate (≥3 months at the maximum tolerated dose) serotonin transporter inhibitor trials (fluoxetine, sertraline, fluvoxamine, paroxetine, citalopram, escitalopram, or clomipramine) alone or in combination with ii. Adequate behavior therapy (≥20 sessions of expert exposure and response prevention), and iii. Augmentation of one of the selective SRIs with clomipramine, a neuroleptic, and clonazepam.
• Age between 21 and 65 years.
• Able to understand and comply with instructions.
• Able to give fully informed, written consent in the judgment of the site Consent Monitor.
• Either drug free or on a stable drug regimen for at least 6 weeks.
• Good general health.
• A family member or significant other, in contact with the patient every 1-3 days, is available and willing to communicate with the research team if the patient's clinical status worsens, and if necessary to accompany patients to study visits.
• The local referring psychiatrist is willing to provide ongoing care during and after the trial

You may not qualify if:

• personal/family history (1st/2nd degree relatives) of schizophrenia or schizoaffective disorder, other primary psychotic disorder, bipolar disorder;
• present PTS;
• present acute suicidality or suicidal ideation;
• personal history of head injury, epilepsy, tic or other neurological disorders, neurodevelopmental (e.g., autism), systemic medical (metabolic, endocrine, chronic inflammatory, vascular, autoimmune) disease from medical records and self-report (all of which may confound interpretation of neuroimaging measures);
• MMSE score \< 24;
• premorbid IQ estimate \< 85;
• visual disturbance (\<20/40 Snellen visual acuity, corrected);
• left/mixed handedness;
• current, or alcohol or illicit substance abuse/dependence in the last 3 months, determined by clinical assessment and urine toxicology;
• contraindications to MRI,: metallic foreign objects, e.g., aneurysm clips/pacemakers, or questionable history of metal fragments, claustrophobia raising the risk of panicking in enclosed spaces;
• positive pregnancy test for women of reproductive age, or women not using medically acceptable birth control throughout the study (barrier and/or oral contraceptives);
• current psychotic symptoms (potential confounding effect on neuroimaging measures; see above);
• an increased risk of seizure, determined by history;
• \) potentially proconvulsant medications (e.g., bupropion, tricyclic antidepressants, first-generation antipsychotics, lithium), and medications reducing cortical excitability (e.g., anticonvulsants, benzodiazepines, atypical antipsychotics).

Sponsors & Collaborators

• Butler Hospital: collaborator
• Rhode Island Hospital: lead
• Brown University: collaborator
• Baylor College of Medicine: collaborator

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Central Study Contacts

Owen Leary, BS

CONTACT

401-444-4362; memory.stimulation@lifespan.org

Darlene Gaudet, MS

CONTACT

401-444-4362; memory.stimulation@lifespan.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2022
• First Posted: December 26, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2031
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share