Trial record 1 of 16 for:    obsessive-compulsive disorder AND deep-brain stimulation
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Effectiveness of Deep Brain Stimulation for Treating People With Treatment Resistant Obsessive-Compulsive Disorder

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Butler Hospital
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Dr. Benjamin Greenberg, Butler Hospital
ClinicalTrials.gov Identifier:
NCT00640133
First received: March 17, 2008
Last updated: June 6, 2014
Last verified: June 2014
  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.


Condition Intervention Phase
Obsessive-Compulsive Disorder
Device: Deep brain stimulation (DBS)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Controlled Trial of Deep Brain Stimulation for Obsessive-Compulsive Disorder

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, monthly for 4 months, then every 3 months for 9 months, and then every 6 months for up to 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life (Quality of Life Enjoyment and Satisfaction Questionnaire), depression severity (Montgomery-Asberg Depression Rating Scale), anxiety (Hamilton Anxiety Rating Scale), and neuropsychological battery [ Time Frame: Measured at baseline, monthly for 4 months, then every 3 months for 9 months, and then every 6 months for up to 4 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: March 2008
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active DBS
Participants will receive deep brain stimulation.
Device: Deep brain stimulation (DBS)
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. After a post-operative rest, some participants will receive immediate DBS treatment; others will receive DBS treatment after a delay of several months. Afterwards, all participants will receive open-label long-term DBS.
Other Names:
  • Activa Deep Brain Stimulation System (Medtronic, Inc.)
  • Implantable Neurostimulator (INS)
Sham Comparator: Sham DBS
Participants will receive sham deep brain stimulation for several months and then active deep brain stimulation thereafter.
Device: Deep brain stimulation (DBS)
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. After a post-operative rest, some participants will receive immediate DBS treatment; others will receive DBS treatment after a delay of several months. Afterwards, all participants will receive open-label long-term DBS.
Other Names:
  • Activa Deep Brain Stimulation System (Medtronic, Inc.)
  • Implantable Neurostimulator (INS)

Detailed Description:

Obsessive-compulsive disorder (OCD) is a chronic and debilitating illness that affects between 2% and 3% of adults in 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 use 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 effectiveness of DBS in treating people with severe and otherwise treatment-resistant OCD.

Study participation through follow-up will last 4 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 3- to 4-day series of initial tests and examinations that will include a physical and neurological examination; blood and urine screening tests; an electrocardiogram (EKG); an electroencephalography (EEG); and detailed psychological testing, including tests of perception, learning, and memory. The EEGs may be performed again after surgery to measure potential changes in brain electrical activity due to DBS.

On the day of the surgery, participants will take a low dose of anxiety medication, have a metal frame fixed to their heads for support during surgery, and undergo a magnetic resonance imaging (MRI) scan to determine where to place the stimulating wires. After being injected with a local anesthetic, participants will undergo the first part of the operation, which will involve the implantation of neurostimulators in the ventral caudate/ventral striatum brain region. For the second part of the operation, after participants are administered general anesthesia, they will have the implantable neurostimulators (INSs) placed in their chests and the connecting wires to the brain placed under their skin. The entire surgical procedure will take 3 to 4 hours, with a 1- to 2-day post-operative hospital stay for recovery. During the post-operative stay, participants will undergo x-rays and a computed tomography (CT) scan of the head.

Two to 3 weeks after surgery, participants will be divided randomly into either a group that receives DBS immediately or a group that first receives sham DBS and then active DBS after 3 months. The level of stimulation will be adjusted individually and on the basis of each participant's response to the stimulation. Participants will complete rating forms, a clinical evaluation, and a check of the stimulators every month for the first 3 months, then at least every 3 months for the rest of the year, and then every 6 months for the remaining years of the study. On the Year 1 visit, participants will repeat the baseline detailed psychological testing. Periodically throughout the 4-year study, staff will contact participants by phone to ask about OCD symptoms, mood, anxiety, and possible side effects. Also throughout the study, participants will need to have the INSs replaced every 5 to 16 months on average.

Participants will also be invited to participate in a related study that involves positron emission tomography (PET) scanning to determine how the stimulation changes activity in the brain. Participation in the separate PET study is optional and will not affect current study participation.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Obsessive-compulsive disorder (OCD), diagnosed by Structured Clinical Interview for DSM-IV (SCID-IV)
  • Presence of disabling severity, as assessed by a Yale-Brown Obsessive Compulsive Scale (YBOCS) score of at least 30
  • Impaired functioning, indicated by a Global Assessment of Functioning (GAF) score of 45 or less
  • Documented highly treatment refractory illness; the documentation must demonstrate persistence of severe symptoms and impairment for 5 or more years despite at least three first-line and two second-line treatments, as follows:

    1. at least three adequate trials of, or documented intolerance to, different serotonin transporter inhibitors (e.g., fluoxetine, sertraline, fluvoxamine, paroxetine, citalopram, escitalopram, clomipramine) for at least 3 months at the maximum tolerated dose. These trials may include any of the agents above, but must include an adequate course of clomipramine, either alone or in combination with a more selective serotonin transporter inhibitor;
    2. augmentation of one of the selective serotonin transporter inhibitors with clomipramine, and a neuroleptic (each for at least 2 weeks); and
    3. adequate behavior therapy (more than 20 sessions of exposure and response prevention by a therapist with substantial expertise in OCD treatment as determined by the investigators) with at least one of these trials and tried in combination with medication therapy
  • Either drug free or on a stable drug regimen for at least 6 weeks before study entry
  • General good overall health
  • If possible, has a family member or significant other who sees the participant regularly, can communicate with the study team as needed, and, if necessary, can attend study visits
  • Local referring psychiatrist willing to provide ongoing care during and after the trial, to work closely with the research team, and to agree that the study psychiatrist will prescribe medications during the 3-month masked phase
  • Platelet count greater than 125,000 per cubic millimeter and a prothrombin time and partial thromboplastin time within normal limits

Exclusion Criteria:

  • Current or past psychotic disorder
  • Full-scale IQ below 75 on the Wechsler Abbreviated Scale of Intelligence (WASI), 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 clinical history of bipolar mood disorder
  • Any current clinically significant neurological disorder or medical illness affecting brain function, other than a tic disorder
  • Any clinically significant abnormality on preoperative MRI
  • Any labeled DBS contraindication, inability to undergo presurgical MRI (e.g., cardiac pacemaker, pregnancy, metal in body, severe claustrophobia), infection, coagulopathy, inability to undergo an awake operation, significant cardiac risk factors, or other medical risk factors for surgery
  • Current or unstable remitted substance abuse or dependence
  • Positive urine toxicology screen for substance abuse
  • Pregnant and/or woman of childbearing age not using effective forms of birth control
  • Clinical history of severe personality disorder
  • An inability to control suicide attempts, imminent risk of suicide in the investigator's judgment, or a history of serious suicidal behavior, which is defined using the Columbia-Suicide Severity Rating Scale (C-SSRS) as either (1) one or more actual suicide attempts in the 3 years before study entry with the lethality rated at 3 or higher, or (2) one or more interrupted suicide attempts with a potential lethality judged to result in serious injury or death
  • Current diagnosis of body dysmorphic disorder
  • Evidence of dementia of other significant cognitive impairment on neuropsychological evaluation
  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: NCT00640133

Contacts
Contact: Roberta McMahon 401-455-6366 rmcmahon@butler.org

Locations
United States, California
Kaiser Permanente Redwood City Hospital Recruiting
Redwood City, California, United States, 94063
Contact: William Wong, MD    650-299-4737    William.T.Wong@kp.org   
Principal Investigator: William Wong, MD         
Sub-Investigator: Mark Sedrak, MD         
United States, District of Columbia
George Washington University Hospital Recruiting
Washington, District of Columbia, United States, 20037
Contact: Stacy Tam-Siu    202-741-2602    stam@mfa.gwu.edu   
Contact: Francesa Copeland    202-741-2602    Fcopeland@mfa.gwu.edu   
Principal Investigator: Don Shields, MD         
Sub-Investigator: Fuad Issa, MD         
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32610
Contact: Dana Mason    352-273-8540    dmason@ufl.edu   
Principal Investigator: Herbert Ward, MD         
Sub-Investigator: Kelly Foote, MD         
Sub-Investigator: Michael Okun, MD         
United States, Illinois
University of Chicago Not yet recruiting
Chicago, Illinois, United States, 60637
Contact: Jon Grant, MD    773-702-9066    jongrant@uchicago.edu   
Principal Investigator: Jon Grant, MD         
Sub-Investigator: Peter Warnke, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Andrew Corse    617-643-5129    acorse@partners.org   
Principal Investigator: Darin D. Dougherty, MD         
Sub-Investigator: Emad Eskandar, MD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Cindy Stoppel    507-284-5914    stoppel.cynthia@mayo.edu   
Principal Investigator: Kendall Lee, MD, PhD         
Sub-Investigator: Osama Abulseoud, MD         
United States, New York
Mount Sinai School of Medicine Recruiting
New York, New York, United States, 10029
Contact: Sam Zhang    212-241-3154    samuel.zhang@mssm.edu   
Principal Investigator: Wayne Goodman, MD         
Sub-Investigator: Brian Kopell, MD         
United States, North Carolina
Wake Forest Baptist Medical Center Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: James Kimball, MD    336-716-9702    jkimball@wakehealth.edu   
Principal Investigator: James Kimball, MD         
Sub-Investigator: Stephen Tatter, MD         
Sub-Investigator: Ihtsham Haq, MD         
United States, Ohio
The Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Adrienna Easterling    216-445-2378    wintera@ccf.org   
Principal Investigator: Donald Malone, MD         
Sub-Investigator: Cynthia Kubu, PhD         
Sub-Investigator: Andre Machado, MD, PhD         
United States, Rhode Island
Butler Hospital Recruiting
Providence, Rhode Island, United States, 02906
Contact: Roberta McMahon    401-455-6366    rmcmahon@butler.org   
Contact: Richard Marsland, RN       rmarsland@gmail.com   
Principal Investigator: Benjamin D. Greenberg, MD, PhD         
Sub-Investigator: Steven A. Rasmussen, MD         
Sponsors and Collaborators
Butler Hospital
Investigators
Principal Investigator: Benjamin D. Greenberg, MD, PhD Butler Hospital/Brown University
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Benjamin Greenberg, Associate Professor, Butler Hospital
ClinicalTrials.gov Identifier: NCT00640133     History of Changes
Other Study ID Numbers: U01 MH076179, U01MH076179, DSIR 83-ATSO
Study First Received: March 17, 2008
Last Updated: June 6, 2014
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:
Obsessive-Compulsive Disorder
Compulsive Personality Disorder
Anxiety Disorders
Mental Disorders
Personality Disorders

ClinicalTrials.gov processed this record on July 28, 2014