Clinical Trial: Deep Brain Stimulation in Treating Patients With Dystonia


	Home	\|	Search	\|	Browse	\|	Resources	\|	Help	\|	What's New	\|	About

Deep Brain Stimulation in Treating Patients With Dystonia

This study is currently recruiting patients.

Sponsored by:	FDA Office of Orphan Products Development Mount Sinai Medical Center
Information provided by:	FDA Office of Orphan Products Development

Purpose

RATIONALE: Dystonia is a disorder in which the muscles that control voluntary movements are persistently or intermittently contracted (not relaxed). Deep brain stimulation is provided by a small, battery operated implant placed under the skin of the chest that delivers low voltage electrical pulses through a wire under the skin that is connected to a specific area of the brain. Deep brain stimulation may help lessen the symptoms of dystonia. PURPOSE: Phase II/III trial to study the effectiveness of deep brain stimulation in treating patients who have dystonia.

Condition	Treatment or Intervention	Phase
Dystonia	Device: implanted pulse generator	Phase II Phase III

MedlinePlus related topics: Dystonia

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II/III Study of Deep Brain Stimulation in Patients With Dystonia

Further Study Details:

Expected Total Enrollment: 15

Study start: September 1997

PROTOCOL OUTLINE: Patients undergo surgery to implant a brain stimulation system consisting of an implanted pulse generator (IPG) in the chest and a wire lead in the globus pallidum internal. After the lead has been implanted, the brain stimulation system is tested. Patients are examined at 1, 3, 6, 9, and 12 months after surgery. A double blinded evaluation, during which the IPG is either off or on, is carried out at 3 and 6 months. Patients are followed every 3 months as long as the brain stimulation system remains in place.

Eligibility

Ages Eligible for Study: 18 Years - 75 Years, Genders Eligible for Study: Both

Criteria

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Idiopathic or secondary cervical, segmental, or generalized dystonia not adequately controlled with traditional pharmacotherapy and/or botulinum toxin --Prior/Concurrent Therapy-- All medical therapy must be stable within the past month Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: No prior destructive neurosurgical procedure Other: At least 3 months since prior botulinum toxin injections --Patient Characteristics-- Age: 18 to 75 Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Cardiovascular: No demand cardiac pacemaker Other: No history of substance abuse

Location and Contact Information

New York
Mount Sinai Medical Center, NY, New York, New York, 10029, United States; Recruiting

Mitchell Francis Brin 212-241-5607

Study chairs or principal investigators

Mitchell Francis Brin, Study Chair, Mount Sinai Medical Center

More Information

Publications

Brin MF, Germano I, Danisi FO, et al.: Deep brain stimulation (DBS) of pallidum in intractable dystonia. Movement Disorders 13(suppl 2): 274, 1998.

Germano IM, Villalobos H, Weisz, et al.: Image-guided computer-assisted technology as adjuvant for placement of deep brain stimulators. Movement Disorders 13(suppl 2): 264, 1998.

Study ID Numbers: 199/13315; MTS-FDR001452
Record last reviewed: March 2000
Record first received: October 18, 1999
ClinicalTrials.gov Identifier: NCT00004421
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-11-09

U.S. National Library of Medicine, Contact NLM Customer Service

National Institutes of Health, Department of Health & Human Services