Trial record 2 of 18 for:    deep brain stimulation OCD

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

This study has been completed.
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Dr. Benjamin Greenberg, Butler Hospital
ClinicalTrials.gov Identifier:
NCT01061983
First received: February 2, 2010
Last updated: February 21, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Obsessive-Compulsive Disorder
Device: Medtronic Activa Deep Brain Stimulation
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Electrical Stimulation of the Internal Capsule for Intractable OCD

Resource links provided by NLM:


Further study details as provided by Butler Hospital:

Primary Outcome Measures:
  • Obsessive-compulsive disorder (OCD) severity (Yale-Brown Obsessive-Compulsive Scale) [ Time Frame: Measured at baseline, then monthly for nine months, then every three months during the open continuation phase ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Depression severity (Hamilton Depression Scale), Anxiety (Hamilton Anxiety Scale), and neuropsychological battery. [ Time Frame: At baseline, monthly for 9 months, then every 3 months for the continuation of the open phase. ] [ Designated as safety issue: No ]

Enrollment: 5
Study Start Date: January 2001
Study Completion Date: October 2012
Primary Completion Date: April 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Deep Brain Stimulation
Participants will receive deep brain stimulation.
Device: Medtronic Activa Deep Brain Stimulation
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.
Other Names:
  • Deep Brain Stimulation (DBS)
  • Activa System
  • Medtronic Activa Deep Brain Stimulation Therapy System

Detailed Description:

Obsessive-compulsive disorder (OCD) is a chronic and debilitating illness that affects between 2% and 3% of the adult population of the United States. People with OCD often experience persistent unwanted thoughts and carry out ritual-like behaviors to rid themselves of these obsessive thoughts. Additionally, OCD symptoms are usually tied with feelings of intense anxiety and functional impairment, making it important for people with OCD to seek effective treatment. Although there are currently many treatment options for OCD, including psychotherapy and medications such as serotonin reuptake inhibitors, between 40% and 60%of people with OCD only partially respond, or do not respond at all, to these treatment methods. Given the large percentage of people who do not respond to aggressive conventional treatments, alternative options are necessary for people with treatment-resistant OCD. Deep brain stimulation (DBS) is a procedure that involves the se of thin wires to carry electric current to parts of the brain associated with producing OCD symptoms. DBS has been effectively and safely used to treat movement disorders, such as Parkinson's disease, and may be beneficial in reducing OCD symptom severity. This study will evaluate the safety and efficacy of DBS in treating people with severe and treatment-resistant OCD.

Study participation through follow-up will last up to 2 years. Participants will be allowed to remain on any pre-surgical medications or behavioral therapy programs throughout the study. Before surgery, all participants will undergo a series of initial tests and examinations that will include psychiatric, medical, and neuropsychological histories and examinations.

Implantation of the devices will be performed at a single session. The leads that are inserted into the anterior limb of each internal capsule, will be implanted under local anesthesia. On the day of the surgery, participants will have a metal frame fixed to their heads for support during surgery, and magnetic resonance imagining (MRI) will be used to determine the exact placement of the wires. An extension wire will pass from the scalp area to the subclavicular region and connect each electrode to a subcutaneous implanted pulse generator (IPG), which will be implanted under general anesthesia. After placement of the DBS system, the patient will be admitted to the hospital for overnight observation for possible complications. Postoperative evaluation will consist of physical and neurological examinations, postoperative CBC, electrolyte panel, x-rays of the head, neck, and chest, a standard shunt series to ensure the integrity of connections, and a head CT scan to monitor for possible postoperative intracranial hemorrhage.

Surgical implantation will be followed by a three-week period with no stimulation, and then an intensive five-day preliminary outpatient stimulation trial, followed by longer-term outpatient stimulation. All patients will follow the same sequence of test conditions. The initial DBS testing will be open, followed by three blocks of testing in which the patients and investigators administering rating scales will not be informed of the stimulation condition. These three blocks will in general be three months long, but may be longer or shorter depending on the stability of any clinical improvement, and the possible emergence of symptom worsening. The remainder of the the study, up to the two-year study endpoint, will consist of a continuation phase of active open stimulation.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01061983

Locations
United States, Rhode Island
Butler Hospital
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
Butler Hospital
Medtronic
Investigators
Principal Investigator: Benjamin D Greenberg, MD, PhD Butler Hospital/Brown University
  More Information

Publications:
Responsible Party: Dr. Benjamin Greenberg, Chief of Outpatient Services, Associate Professor of Psychiatry, Butler Hospital
ClinicalTrials.gov Identifier: NCT01061983     History of Changes
Other Study ID Numbers: 000204
Study First Received: February 2, 2010
Last Updated: February 21, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Butler Hospital:
Deep brain stimulation
Treatment refractory
Ventral internal capsule/ventral striatum
Neurosurgery
Neuroimaging

Additional relevant MeSH terms:
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Disease
Personality Disorders
Mental Disorders
Anxiety Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014