Patient-specific, Effective, and Rational Functional Connectivity Targeting for DBS in OCD

NCT03244852 | Withdrawn DMC

• 1 other identifier: 2017P000882
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to improve patient-specific anatomical targeting of the 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 (4)

• Yale-Brown Obsessive-Compulsive Scale (YBOCS)

  Yale-Brown Obsessive-Compulsive Scale (YBOCS) will be the principal outcome measure to correlate OCD symptoms severity.

  6 months

• Yale-Brown Obsessive-Compulsive Scale (YBOCS) and Neural Correlates (1)

  Clinical improvement (change in YBOCS from baseline) will be correlated with the degree of postoperative capture of OFC fibers in the VTA of the active DBS contact

  6 months

• Yale-Brown Obsessive-Compulsive Scale (YBOCS) and Neural Correlates (2)

  Clinical improvement (change in YBOCS from baseline) will be correlated with overlap of the volume of tissue activated (VTA) with the identified ventral striatum voxels of maximal preoperative connectivity to the OFC.

  6 months

• Yale-Brown Obsessive-Compulsive Scale (YBOCS) and Neural Correlates (3)

  Clinical improvement (change in YBOCS from baseline) will be correlated with changes in regional glucose metabolism in the OFC, caudate, and thalamus.

  6 months

Study Arms (1)

OCD Patients with Deep Brain Stimulators

Patients with deep brain stimulation for intractable obsessive compulsive disorder (OCD)

Eligibility Criteria

• Age: 21 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be 11 patients with DSM-5-defined OCD of disabling severity, refractory to prolonged treatment trials with conventional medication and behavioral therapy, who would therefore otherwise be candidates for psychiatric neurosurgery.

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 64 years.
• Able to understand and comply with instructions.
• Able to give fully informed, written consent.
• Approved to be implanted with a DBS device for OCD.

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.
• 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 disorder.
• Evidence of dementia or other significant cognitive impairment on neuropsychological evaluation
• Past or present diagnosis of hoarding disorder.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Charlestown, Massachusetts, 02129, United States

Location

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: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry

Study Record Dates

• First Submitted: June 26, 2017
• First Posted: August 10, 2017
• Study Start: September 15, 2017
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)