Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Deep Brain Stimulation for Treatment-Resistant Obsessive Compulsive Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00057603
Recruitment Status : Completed
First Posted : April 8, 2003
Last Update Posted : November 9, 2011
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of Florida

Brief Summary:
This study will evaluate the use of Deep Brain Stimulation (DBS) to reduce symptom severity and enhance the quality of life for patients with treatment-resistant obsessive compulsive disorder (OCD).

Condition or disease Intervention/treatment Phase
Obsessive-Compulsive Disorder Procedure: Deep Brain Stimulation Not Applicable

Detailed Description:

Despite advances in pharmacological and behavioral therapies for OCD, a substantial number of patients fail to improve significantly following years of conventional and experimental interventions. For some patients, stereotactic neurosurgery is the only promising option available. Although this procedure has relatively few side effects in the majority of OCD patients and may lead to enduring benefits, its effects on brain tissue and function are irreversible. Bilateral deep brain stimulation (DBS) is an adjustable and partially reversible procedure that may be a more effective treatment for patients with OCD. This study will determine the effectiveness, safety, and tolerability of DBS in patients with treatment-refractory OCD.

Participants receive DBS treatment for 30 months. Obsessive Compulsive scales, depression scales, neuropsychological evaluations, and surveys are used to assess participants.

Participants are monitored for 2 years after DBS treatment.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of DBS for Treatment-Refractory OCD
Study Start Date : January 2001
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Deep Brain Stimulation
Participants receive deep brain stimulation treatment for 30 months.
Procedure: Deep Brain Stimulation
Deep brain stimulation sends electrical signals to specific parts of the brain, which block the impulses that cause neurological dysfunction.




Primary Outcome Measures :
  1. Obsessive-compulsive scales, depression scales, neuropsychological evaluations, and survey [ Time Frame: Measured pre- and post-intervention ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   23 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Intractable, malignant, and treatment refractory OCD that has caused substantial suffering and a reduction in the patient's psychosocial functioning for > 5 years
  • Poor prognosis without neurosurgical intervention
  • Failed an adequate trial of clomipramine and at least two of the following selective serotonin reuptake inhibitors (SSRIs): fluoxetine, fluvoxamine, citalopram, sertraline, and paroxetine. Additionally, patients must have failed augmentation treatment with at least one of the above drugs for 1 month with at least two of the following: clonazepam, haloperidol, risperidone, olanzapine, and gabapentin.
  • Willingness to undergo augmentation treatment with a low-dose neuroleptic if tics are present prior to surgery
  • Failed an adequate trial of cognitive behavioral therapy/exposure response prevention while taking clomipramine and an SSRI

Exclusion Criteria:

  • Current or lifetime Axis I diagnosis that substantially complicates function, treatment, or the subject's ability to comply with study procedures, or may lead to serious adverse events such as overdose, attempted suicide, or other potentially threatening behaviors
  • Diagnosis and/or treatment for depression within the past year. Patients with a more distant history of depression will not be excluded.
  • Previous neurosurgical procedure or AXIS III diagnosis of brain pathology
  • Implants that contain electrical circuitry, generate electrical signals, and/or have metal parts
  • Nonremovable body jewelry
  • Anticoagulants or other medications that would put patients at risk for surgery-related complications
  • Diathermy for physical therapy
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00057603


Locations
Layout table for location information
United States, Florida
University of Florida College of Medicine
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
National Institute of Mental Health (NIMH)
Investigators
Layout table for investigator information
Principal Investigator: Herbert Ward, MD University of Florida
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00057603    
Other Study ID Numbers: R21MH064161 ( U.S. NIH Grant/Contract )
R21MH064161 ( U.S. NIH Grant/Contract )
DATR A5-ETMA
First Posted: April 8, 2003    Key Record Dates
Last Update Posted: November 9, 2011
Last Verified: November 2011
Additional relevant MeSH terms:
Layout table for MeSH terms
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Personality Disorders
Mental Disorders
Anxiety Disorders