Combined Cortical/Subcortical Recording and Stimulation as a Circuit-Oriented Treatment for Obsessive-Compulsive Disorder

NCT03184454 | Active Not Recruiting DMC FDA Device

• 1 other identifier: 2015P000456
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 2

Brief Summary

This study involves the use of the Medtronic PC+S deep brain stimulation for the treatment of intractable OCD.

Conditions

Obsessive Compulsive Disorder

Keywords

OCD; deep brain stimulation; treatment-resistant OCD

Outcome Measures

Primary Outcomes (1)

• Yale-Brown Obsessive-Compulsive Scale (YBOCS)

  The Yale-Brown Obsessive-Compulsive Scale (YBOCS) will be the principal outcome measure for tracking OCD symptoms. We will collect this measure at all clinical visits.

  2 years

Secondary Outcomes (3)

• Montgomery-Asberg Depression Rating Scale (MADRS)

  2 years

• Clinical Global Impressions (CGI) Severity and Change scale

  2 years

• Patient Global Impressions (PGI) scale

  2 years

Study Arms (1)

Medtronic Percept Deep Brain Stimulation

EXPERIMENTAL

Single open label arm. Patients with severe, treatment-refractory obsessive-compulsive disorder (OCD) will receive stimulation in two separate, but related, brain regions, the dorsolateral prefrontal cortex (dlPFC) and the ventral anterior limb of the internal capsule and adjacent ventral striatum (VC/VS) with a novel Medtronic Percept deep brain stimulation (DBS) system.

Device: Medtronic Percept Deep Brain Stimulation

Interventions

Medtronic Percept Deep Brain Stimulation DEVICE

Deep Brain stimulation involves bilateral stereotactic placement of stimulating "leads" into specific brain structures. Leads are attached to permanent subcutaneous wires and battery-powered implantable neurostimulators (INSs). Noninvasive INS programming can achieve a balance between maximal benefit (reduction in disabling OCD symptoms), while minimizing adverse effects (eg sensorimotor effects such as dysarthria or paresthesias; as well as behavioral side effects, e.g., hypomania, insomnia, or increased anxiety).

Medtronic Percept Deep Brain Stimulation

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-5 (SCID-5), judged of disabling severity with a Yale-Brown Obsessive Compulsive Scale (YBOCS) score of at least 28.
• Persistence of severe symptoms and impairment for five or more years despite: i. at least three adequate (≥3 months at the maximum tolerated dose) serotonin transporter inhibitor trials (may use any serotonin or serotonin-norepinephrine inhibitors, but must include a trial of clomipramine) alone or in combination with ii. adequate behavior therapy (≥20 sessions of expert exposure and response prevention; At least 20 sessions of behavioral therapy must be attempted), and iii. augmentation of one of the selective SRIs with a neuroleptic or 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.
• Patient is aware of, able to adhere to, and willing to tolerate the frequency of visits associated with adjustment of the dual-stimulation configuration and/or collection of brain recordings. This will usually mean limitation to patients who live close to the study site.
• Platelet count greater than 125,000 per cubic millimeter and a PT and PTT within normal limits.

You may not qualify if:

• Current or past psychotic disorder.
• Full-scale IQ below 75 on the Wechsler Abbreviated Scale of Intelligence (WAIS) or cognitive impairment that would affect a participant's ability to give informed consent or provide interview or self-report data reliably, as determined by the consent monitor and the site psychiatrist. A questionnaire assessing consent comprehension will be used with all study subjects, to ensure that they understand the key procedures of the study, and its risks and benefits. An independent monitor will administer that questionnaire.
• A clinical history of bipolar mood disorder. We will not exclude substance-induced mania or hypomania.
• In our prior studies, a history of induced hypomanic symptoms did not predict DBS-related hypomania.
• Any current clinically significant neurological disorder or medical illness affecting brain function, other than tic disorders or Tourette syndrome.
• Any clinically significant abnormality on preoperative magnetic resonance imaging (MRI).
• Any labeled DBS contraindication and/or inability to undergo presurgical MRI (cardiac pacemaker, pregnancy, metal in body, severe claustrophobia), infection, coagulopathy, inability to undergo an awake operation, significant cardiac or other medical risk factors for surgery.
• Current or unstably remitted substance abuse, dependence, or a positive urine toxicology screen.
• Pregnancy and women of childbearing age not using effective contraception.
• Unable to adhere to operational and administrative study requirements (in the investigators' judgment).
• Clinical history of severe personality disorder.
• Imminent risk of suicide or an inability to control suicide attempts (in the investigators' judgment).
• History of serious suicidal behavior or one or more interrupted suicide attempts with potential lethality judged to result in serious injury or death.
• Diagnosis of body dysmorphic or hoarding disorder.
• Evidence of dementia or other significant cognitive impairment on neuropsychological evaluation or through cognitive screening (MOCA).

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (2)

Massachusetts General Hospital

Charlestown, Massachusetts, 02129, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55454, United States

Location

Related Publications (1)

• Olsen ST, Basu I, Bilge MT, Kanabar A, Boggess MJ, Rockhill AP, Gosai AK, Hahn E, Peled N, Ennis M, Shiff I, Fairbank-Haynes K, Salvi JD, Cusin C, Deckersbach T, Williams Z, Baker JT, Dougherty DD, Widge AS. Case Report of Dual-Site Neurostimulation and Chronic Recording of Cortico-Striatal Circuitry in a Patient With Treatment Refractory Obsessive Compulsive Disorder. Front Hum Neurosci. 2020 Oct 23;14:569973. doi: 10.3389/fnhum.2020.569973. eCollection 2020.

  PMID: 33192400 DERIVED

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Cristina Cusin, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Psychiatry

Model Details: Cortical and subcortical electrodes

Study Record Dates

• First Submitted: June 9, 2017
• First Posted: June 12, 2017
• Study Start: March 1, 2019
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

US (2)