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NCT04605263 · ClinicalTrials.gov record · last posted 2024-11-29

Deep Brain Stimulation (DBS) of the Pedunculopontine Nucleus (PPN)

Study acronym: PPNGB01
StatusEnrolling by Invitation
PhaseNot applicable
Started2021-11-01
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from the ClinicalTrials.gov record
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 Parkinson's 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.

Amendment record 4 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 4 times since 2020-10-26; most recent amendment 2024-11-26. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

Trial Details
NCT Number NCT04605263
Lead Sponsor St. Joseph's Hospital and Medical Center, Phoenix
Collaborators: Arizona State University
Conditions Parkinson Disease
Enrollment 8 participants
Start Date 2021-11-01
Primary Completion 2026-09-01 (estimated)
Study Completion 2027-09-01 (estimated)
Updated on ClinicalTrials.gov 2024-11-29