This observational clinical trial (NCT05656586), known as Udall Project 2 Aim 2A&C, investigates the mechanisms and effects of pallidal deep brain stimulation on levodopa-resistant motor signs in Parkinson's disease. The study is conducted by the University of Minnesota as part of the national Udall Center of Excellence program, focusing on understanding how local field potentials (LFPs) recorded from implanted DBS electrodes correlate with motor symptoms 1.
| Parameter | Value |
|---|---|
| NCT Number | NCT05656586 |
| Official Title | Mechanisms and Effects of Pallidal Deep Brain Stimulation on Levodopa Resistant Motor Signs in Parkinson's Disease; Udall Project 2 Aim 2A&C |
| Status | Recruiting |
| Study Type | Observational |
| Sponsor | University of Minnesota |
| Start Date | January 1, 2023 |
| Primary Completion | March 1, 2027 |
| Completion Date | March 1, 2028 |
| Location | Minneapolis, Minnesota, United States |
The Udall Center of Excellence program, established by the National Institute of Neurological Disorders and Stroke (NINDS), supports multidisciplinary research centers focused on understanding the causes and mechanisms of Parkinson's disease. The University of Minnesota Udall Center conducts research on:
Globus pallidus internus (GPi) DBS is an established treatment for Parkinson's disease, particularly effective for:
Unlike subthalamic nucleus (STN) DBS, GPi stimulation may preserve more cognitive function and have fewer side effects related to speech and gait.
LFPs represent aggregated neural activity recorded from electrodes in the brain. In Parkinson's disease:
The Medtronic Percept DBS system can record LFPs from the implanted electrodes, enabling research into biomarker-driven adaptive stimulation 2.
The primary aims of Udall Project 2 are:
The study employs multiple assessment modalities:
| Measure | Description | Timeframe |
|---|---|---|
| Peak negative power | Ankle rigidity assessment using servo-controlled manipulandum | 30 days |
| Stride length | Spatial parameters of overground gait | 30 days |
| Alpha power during gait | LFP recordings during standardized daily gait assessments | 30 days |
| Cadence | Temporal parameters of gait | 30 days |
| Measure | Description | Timeframe |
|---|---|---|
| Gait speed | Steady-state gait velocity | 30 days |
| Time away from home | Activity monitoring via mPower app | 30 days |
| Distance traveled | GPS-derived mobility metrics | 30 days |
| LFP after freezing of gait | Alpha power following freezing episodes | 30 days |
| Peak LFP oscillation power | Daytime alpha and beta power spectral density | 30 days |
| Stride time variability | Gait timing consistency | 30 days |
| Step length variability | Spatial gait consistency | 30 days |
Many Parkinson's disease patients develop motor signs that no longer respond well to levodopa:
This study aims to characterize the neural correlates of these treatment-resistant signs.
By correlating LFP biomarkers with motor symptoms, this research supports development of:
The study's focus on home-based LFP recordings and wearable device integration represents an important step toward: