Deep Brain Stimulation in Treating Patients With Dystonia

This study has been completed.
Sponsor:
Collaborator:
Mount Sinai School of Medicine
Information provided by:
FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:
NCT00004421
First received: October 18, 1999
Last updated: July 21, 2008
Last verified: March 2000
  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 2
Phase 3

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

Resource links provided by NLM:


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
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, see Learn About Clinical Studies.

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
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.

ClinicalTrials.gov Identifier: NCT00004421     History of Changes
Other Study ID Numbers: 199/13315, MTS-FDR001452
Study First Received: October 18, 1999
Last Updated: July 21, 2008
Health Authority: United States: Federal Government

Keywords provided by FDA Office of Orphan Products Development:
dystonia
neurologic and psychiatric disorders
rare disease

Additional relevant MeSH terms:
Dystonia
Dystonic Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases

ClinicalTrials.gov processed this record on September 14, 2014