Ignite Creation Date:
2024-05-06 @ 7:24 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06008717
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-11
First Post:
2022-12-23
Brief Title:
Double-Blind Clinical Trial of Subthalamic Nucleus Deep Brain Stimulation in Early-Stage Parkinsons Disease
Sponsor:
Mallory Hacker
Organization:
Vanderbilt University Medical Center
Study Overview
Official Title:
A Prospective Randomized Feasibility Clinical Trial Evaluating Bilateral Stimulation of the Dorsolateral Region of the Subthalamic Nucleus Receiving Hyperdirect M1SMA Input in Subjects With Early-Stage Parkinsons Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
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:
The goal of this trial is to evaluate the preliminary safety and efficacy of programming to maximize stimulation of the dorsolateral region of the subthalamic nucleus STN receiving primary motor M1 and supplementary motor area SMA but not pre-SMA input deep brain stimulation DBS in patients with early-stage Parkinsons disease PD
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None