Deep Brain Stimulation for Treatment-Resistant Obsessive Compulsive Disorder - Full Text View

Purpose

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	Intervention
Obsessive-Compulsive Disorder	Procedure: Deep Brain Stimulation

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Pilot Study of DBS for Treatment-Refractory OCD

Resource links provided by NLM:

MedlinePlus related topics: Obsessive-Compulsive Disorder

U.S. FDA Resources

Further study details as provided by University of Florida:

Primary Outcome Measures:

Obsessive-compulsive scales, depression scales, neuropsychological evaluations, and survey [ Time Frame: Measured pre- and post-intervention ] [ Designated as safety issue: Yes ]

Enrollment:	6
Study Start Date:	January 2001
Study Completion Date:	July 2009
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

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.

Eligibility

Ages Eligible for Study:	23 Years to 65 Years
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00057603

Locations

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

Principal Investigator:

Herbert Ward, MD

University of Florida

More Information

No publications provided by University of Florida

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Vora AK, Ward H, Foote KD, Goodman WK, Okun MS. Rebound symptoms following battery depletion in the NIH OCD DBS cohort: clinical and reimbursement issues. Brain Stimul. 2012 Oct;5(4):599-604. doi: 10.1016/j.brs.2011.10.004. Epub 2011 Nov 4.

Goodman WK, Foote KD, Greenberg BD, Ricciuti N, Bauer R, Ward H, Shapira NA, Wu SS, Hill CL, Rasmussen SA, Okun MS. Deep brain stimulation for intractable obsessive compulsive disorder: pilot study using a blinded, staggered-onset design. Biol Psychiatry. 2010 Mar 15;67(6):535-42. Epub 2010 Feb 8.

Responsible Party:	University of Florida
ClinicalTrials.gov Identifier:	NCT00057603 History of Changes
Other Study ID Numbers:	R21 MH64161, R21MH064161, DATR A5-ETMA
Study First Received:	April 4, 2003
Last Updated:	November 8, 2011
Health Authority:	United States: Federal Government United States: Institutional Review Board

Additional relevant MeSH terms:

Obsessive-Compulsive Disorder
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013