Deep Brain Stimulation in Treating Patients With Dystonia

This study has been completed.

First Received: October 18, 1999 Last Updated: July 21, 2008 History of Changes

Sponsors and Collaborators:	FDA Office of Orphan Products Development Mount Sinai School of Medicine
Information provided by:	FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:	NCT00004421

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	Intervention	Phase
Dystonia	Device: implanted pulse generator	Phase II Phase III

Genetics Home Reference related topics: early-onset primary dystonia familial paroxysmal nonkinesigenic dyskinesia

MedlinePlus related topics: Dystonia

U.S. FDA Resources

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

Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment:	15
Study Start Date:	September 1997

Detailed Description:

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004421

Locations

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

Sponsors and Collaborators

FDA Office of Orphan Products Development

Mount Sinai School of Medicine

Investigators

Study Chair:

Mitchell Francis Brin

Mount Sinai School of Medicine

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
Study First Received:	October 18, 1999
Last Updated:	July 21, 2008
ClinicalTrials.gov Identifier:	NCT00004421 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by FDA Office of Orphan Products Development:

dystonia
neurologic and psychiatric disorders
rare disease

Study placed in the following topic categories:

Dystonic Disorders
Signs and Symptoms
Movement Disorders
Mental Disorders
Rare Diseases

Central Nervous System Diseases
Neurologic Manifestations
Dystonia
Dyskinesias

Additional relevant MeSH terms:

Dystonic Disorders
Signs and Symptoms
Movement Disorders
Nervous System Diseases

Central Nervous System Diseases
Neurologic Manifestations
Dystonia
Dyskinesias

ClinicalTrials.gov processed this record on May 07, 2009