NCT00004421

Deep Brain Stimulation in Treating Patients With Dystonia

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

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

Conditions

• Dystonia

Interventions

Type	Name	Description
DEVICE	implanted pulse generator

Timeline

• Start date: 1997-09-01
• Completion: 2000-09-01
• First posted: 1999-10-19
• Last updated: 2015-03-25

Locations

1 site across 1 country: United States