Ignite Creation Date:
2024-05-06 @ 3:21 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04605263
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-11-22
First Post:
2020-08-31
Brief Title:
Deep Brain Stimulation DBS of the Pedunculopontine Nucleus PPN
Sponsor:
St Josephs Hospital and Medical Center Phoenix
Organization:
St Josephs Hospital and Medical Center Phoenix
Study Overview
Official Title:
Effects of Deep Brain Stimulation DBS of the Pedunculopontine Nucleus PPN on Gait Postural Stability Freezing of Gait FOG and Falls
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PPNGB01
Brief Summary:
This is a mechanistic study to determine the differential effects of the dopaminergic and cholinergic systems on attention gait and balance The primary goal of the study is to evaluate the relative effects of pedunculopontine nucleus PPN and subthalamic nucleus STN Deep Brain Stimulation DBS on these features in persons with Parkinsons Disease PD who are eligible for DBS for improvement of their motor symptoms and exhibit gait instability with falls Patients will be enrolled and implanted with bilateral electrodes in one of the approved DBS locations subthalamic nucleus STN but additionally electrodes will be inserted into the experimental target namely the PPN bilaterally
Detailed Description:
This is a prospective single-center randomized controlled trial designed to estimate the potential clinical benefit and associated risks of deep brain stimulation of the of the PPN and STN in patients with PD that are candidates for DBS for improvement of their motor symptoms and exhibit gait instability with falls Patients will be enrolled and implanted with additional bilateral electrodes in the PPN Each subject will be randomized 11 to one of the following sequences Bilateral STNPPN stimulation or Bilateral STN stimulation alone The addition of a bilateral STN stimulation only group allows for the research of potential micro-lesioning effects of the PPN which might affect features of interest even in the absence of PPN stimulation
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