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