Electrical Stimulation of the Internal Capsule for Intractable Obsessive-compulsive Disorder (OCD)

Completed · Phase 2

Conditions studied: Obsessive-Compulsive Disorder

In brief

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.

Key facts

Study ID

NCT01061983

Run by

Butler Hospital

People needed

5

Starts

2001-01-01

Expected to finish

2012-10-01

Last updated by the study team

2013-02-25

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Butler Hospital — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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