Deep Brain Stimulation in Treating Patients With Dystonia

Sponsor

Icahn School of Medicine at Mount Sinai (Other)

Overall Status

Completed

CT.gov ID

NCT00004421

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 1997

Study Completion Date :

Sep 1, 2000

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Mount Sinai Medical Center, NY	New York	New York	United States	10029

Sponsors and Collaborators

Icahn School of Medicine at Mount Sinai

Investigators

Study Chair: Mitchell Francis Brin, Icahn School of Medicine at Mount Sinai

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00004421

Other Study ID Numbers:

199/13315
MTS-FDR001452

First Posted:

Oct 19, 1999

Last Update Posted:

Mar 25, 2015

Last Verified:

Mar 1, 2000

Keywords provided by , ,

dystonia

neurologic and psychiatric disorders

rare disease

Additional relevant MeSH terms:

Dystonia

Dystonic Disorders

Study Results

No Results Posted as of Mar 25, 2015