Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004421
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
1999-10-18
Brief Title:
Deep Brain Stimulation in Treating Patients With Dystonia
Sponsor:
Icahn School of Medicine at Mount Sinai
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
Phase IIIII Study of Deep Brain Stimulation in Patients With Dystonia
Status:
COMPLETED
Status Verified Date:
2000-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 IIIII trial to study the effectiveness of deep brain stimulation in treating patients who have dystonia
PURPOSE Phase IIIII 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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MTS-FDR001452 | None | None | None |