NCT01061983

Brief Summary

This study will evaluate the safety and effectiveness of deep brain stimulation in treating people with severe and otherwise treatment-resistant obsessive-compulsive disorder. We also expect to determine how DBS affects brain activity in brain circuits strongly implicated in OCD, and how such effects may relate to symptom change. This treatment study therefore also permits a unique and crucial test of current neuroanatomical models of both OCD pathogenesis and mechanisms underlying the response to treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2001

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2001

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2004

Completed
5.8 years until next milestone

First Submitted

Initial submission to the registry

February 2, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 4, 2010

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

February 25, 2013

Status Verified

February 1, 2013

Enrollment Period

3.2 years

First QC Date

February 2, 2010

Last Update Submit

February 21, 2013

Conditions

Obsessive-Compulsive Disorder

Keywords

Deep brain stimulationTreatment refractoryVentral internal capsule/ventral striatumNeurosurgeryNeuroimaging

Outcome Measures

Primary Outcomes (1)

  • Obsessive-compulsive disorder (OCD) severity (Yale-Brown Obsessive-Compulsive Scale)

    Measured at baseline, then monthly for nine months, then every three months during the open continuation phase

Secondary Outcomes (1)

  • Depression severity (Hamilton Depression Scale), Anxiety (Hamilton Anxiety Scale), and neuropsychological battery.

    At baseline, monthly for 9 months, then every 3 months for the continuation of the open phase.

Study Arms (1)

Deep Brain Stimulation

EXPERIMENTAL

Participants will receive deep brain stimulation.

Device: Medtronic Activa Deep Brain Stimulation

Interventions

Medtronic Activa Deep Brain StimulationDEVICE

In DBS, thin wires are used to carry electric current to the parts of the brain involved in OCD symptoms. These wires are implanted surgically and are attached to battery operated stimulators usually implanted in the chest. The study doctor will adjust the settings of the electrical stimulation to optimize treatment for each participant.

Also known as: Deep Brain Stimulation (DBS), Activa System, Medtronic Activa Deep Brain Stimulation Therapy System
Deep Brain Stimulation

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • OCD, diagnosed by Structural Clinical Interview for DSM-IV (SCID-IV), judged to be of disabling severity with a Yale-Brown Obsessive-Compulsive Scale (YBOCS) score of 28 and a Global Assessment of Function (GAF) score of 45 or less.
  • Persistence of this level of impairment for a minimum of five years despite adequate trials of or intolerance to 3 or 4 selective serotonin transporter inhibitors including fluoxetine, sertraline, fluvoxamine, paroxetine and clomipramine alone and in combination with behavior therapy, and augmentation of one of the selective SRIs with clomipramine, a neuroleptic, and clonazepam.
  • Age of at least eighteen years, and no more than 55 years.
  • Able to understand and comply with instructions.
  • Written informed consent.
  • Either drug free or on a stable drug regime for at least 6 weeks.
  • Good general health.

You may not qualify if:

  • Current or past psychotic disorder.
  • Any clinically significant neurological disorder or medical illness affecting brain function, other than motor tics or Gilles de la Tourette syndrome.
  • Any clinically significant abnormality on preoperative magnetic resonance imaging (MRI).
  • Any surgical contraindications to undergoing DBS, including labeled contraindications for DBS and/or inability to undergo presurgical MRI (cardiac pacemaker, pregnancy, metal in body, severe claustrophobia), infection, coagulopathy, inability to undergo awake operation, significant cardiac or other medical risk factors for surgery.
  • Current or unstably remitted substance abuse disorder.
  • Pregnancy and women of childbearing age not using effective contraception.
  • History of body dysmorphic disorder.
  • History of severe personality disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

Related Publications (3)

  • Greenberg BD, Gabriels LA, Malone DA Jr, Rezai AR, Friehs GM, Okun MS, Shapira NA, Foote KD, Cosyns PR, Kubu CS, Malloy PF, Salloway SP, Giftakis JE, Rise MT, Machado AG, Baker KB, Stypulkowski PH, Goodman WK, Rasmussen SA, Nuttin BJ. Deep brain stimulation of the ventral internal capsule/ventral striatum for obsessive-compulsive disorder: worldwide experience. Mol Psychiatry. 2010 Jan;15(1):64-79. doi: 10.1038/mp.2008.55. Epub 2008 May 20.

    PMID: 18490925RESULT

  • Greenberg BD, Malone DA, Friehs GM, Rezai AR, Kubu CS, Malloy PF, Salloway SP, Okun MS, Goodman WK, Rasmussen SA. Three-year outcomes in deep brain stimulation for highly resistant obsessive-compulsive disorder. Neuropsychopharmacology. 2006 Nov;31(11):2384-93. doi: 10.1038/sj.npp.1301165. Epub 2006 Jul 19.

    PMID: 16855529RESULT

  • Rauch SL, Dougherty DD, Malone D, Rezai A, Friehs G, Fischman AJ, Alpert NM, Haber SN, Stypulkowski PH, Rise MT, Rasmussen SA, Greenberg BD. A functional neuroimaging investigation of deep brain stimulation in patients with obsessive-compulsive disorder. J Neurosurg. 2006 Apr;104(4):558-65. doi: 10.3171/jns.2006.104.4.558.

    PMID: 16619660RESULT

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsSurgical Procedures, Operative

Study Officials

  • Benjamin D Greenberg, MD, PhD

    Butler Hospital/Brown University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Outpatient Services, Associate Professor of Psychiatry

Study Record Dates

First Submitted

February 2, 2010

First Posted

February 4, 2010

Study Start

January 1, 2001

Primary Completion

April 1, 2004

Study Completion

October 1, 2012

Last Updated

February 25, 2013

Record last verified: 2013-02

Locations

US(1)