Deep Brain Stimulation in Treating Patients With Dystonia

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. Identifier: NCT00004421
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : March 25, 2015
Information provided by:
FDA Office of Orphan Products Development

Brief Summary:

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 or disease Intervention/treatment Phase
Dystonia Device: implanted pulse generator Phase 2 Phase 3

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.

Completion date provided represents the completion date of the grant per OOPD records

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Primary Purpose: Treatment
Official Title: Phase II/III Study of Deep Brain Stimulation in Patients With Dystonia
Study Start Date : September 1997
Study Completion Date : September 2000

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dystonia

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


--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

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 identifier (NCT number): NCT00004421

United States, New York
Mount Sinai Medical Center, NY
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Study Chair: Mitchell Francis Brin Icahn School of Medicine at Mount Sinai

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. Identifier: NCT00004421     History of Changes
Other Study ID Numbers: 199/13315
First Posted: October 19, 1999    Key Record Dates
Last Update Posted: March 25, 2015
Last Verified: March 2000

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

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