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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00640133 |
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) Device: Sham DBS |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | Controlled Trial of Deep Brain Stimulation for Obsessive-Compulsive Disorder |
Estimated Enrollment: | 30 |
Study Start Date: | March 2008 |
Estimated Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Participants will receive deep brain stimulation.
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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.
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2: Sham Comparator
Participants will receive sham deep brain stimulation for 3 months and then active deep brain stimulation thereafter.
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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.
Device: Sham DBS
Participants will receive sham DBS in the same fashion as the active treatment for 3 months.
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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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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:
Exclusion Criteria:
United States, Florida | |
University of Florida | Recruiting |
Gainesville, Florida, United States, 32610 | |
Contact: Nikki Ricciuti 352-392-8316 nikkir@ufl.edu | |
Principal Investigator: Tanya Murphy, MD | |
Sub-Investigator: Kelly Foote, MD | |
Sub-Investigator: Michael Okun, MD | |
United States, Maryland | |
National Institute of Mental Health | Active, not recruiting |
Bethesda, Maryland, United States, 20892 | |
United States, Massachusetts | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Contact: Johanna Thompson-Hollands 617-726-9281 JTHOMPSON-HOLLANDS@partners.org | |
Principal Investigator: Darin D. Dougherty, MD | |
Sub-Investigator: Emad Eskandar, MD | |
United States, Ohio | |
The Cleveland Clinic | Recruiting |
Cleveland, Ohio, United States, 44195 | |
Contact: Jenna Stump 216-444-2673 stumpj@ccf.org | |
Principal Investigator: Ali Rezai, MD | |
Sub-Investigator: Donald Malone, MD | |
Sub-Investigator: Cynthia Kubu, PhD | |
United States, Rhode Island | |
Butler Hospital | Recruiting |
Providence, Rhode Island, United States, 02906 | |
Contact: Richard Marsland, RN 401-455-6211 rmarsland@butler.org | |
Contact: Cynthia Read, MA cynthia.read@gmail.com | |
Principal Investigator: Benjamin D. Greenberg, MD, PhD | |
Sub-Investigator: Steven A. Rasmussen, MD | |
Sub-Investigator: Gerhard Friehs, MD |
Principal Investigator: | Herbert Ward, MD | University of Florida College of Medicine |
Responsible Party: | University of Florida College of Medicine ( Herbert Ward, MD ) |
Study ID Numbers: | U01 MH076179, DSIR 83-ATSO |
Study First Received: | March 17, 2008 |
Last Updated: | October 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00640133 |
Health Authority: | United States: Food and Drug Administration |
Deep Brain Stimulation Treatment Refractory Ventral Internal Capsule/Ventral Striatum Neurosurgery Neuroimaging |
Anxiety Disorders Mental Disorders Obsessive-Compulsive Disorder |
Pathologic Processes Disease |