Udall Project 2: Pallidal DBS LFP Study (NCT05656586)

Udall Project 2: Pallidal Deep Brain Stimulation LFP Study

Overview

Udall Project 2: Pallidal Deep Brain Stimulation LFP Study

Overview

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](/diseases/parkinsons-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](/mechanisms/neural-oscillations-parkinsons) (LFPs) recorded from implanted DBS electrodes correlate with motor symptoms [1](https://clinicaltrials.gov/study/NCT05656586).

Trial Details

| 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 |

Background

The Udall Centers of Excellence

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:

• Neural circuit dysfunction in PD
• Biomarker development for disease progression
• Novel therapeutic approaches including adaptive DBS
• Mechanisms of levodopa-resistant motor signs

Why Pallidal DBS?

[Globus pallidus internus](/cell-types/globus-pallidus) (GPi) DBS is an established treatment for Parkinson's disease, particularly effective for:

• Levodopa-induced dyskinesias
• Motor fluctuations
• Tremor, rigidity, and bradykinesia

Local Field Potentials as Biomarkers

LFPs represent aggregated neural activity recorded from electrodes in the brain. In Parkinson's disease:

• Beta oscillations (13-35 Hz) are elevated and correlate with rigidity and bradykinesia
• Alpha oscillations (8-12 Hz) may be suppressed during movement
• Pathological synchronization disrupts normal motor circuit function

Study Design

Objectives

The primary aims of Udall Project 2 are:

Assessment Battery

The study employs multiple assessment modalities:

Motor Assessments

• Quantitative testing of rigidity using servo-controlled ankle manipulandum
• Gait analysis using computerized walkway
• Standardized clinical ratings (MDS-UPDRS)

Neural Recordings

• In-clinic LFP recordings using Medtronic Percept system
• At-home LFP capture during standardized daily gait assessments
• Event-triggered recordings following freezing of gait or falls

Real-World Monitoring

• mPower smartphone app for continuous activity tracking
• Gait parameters derived from wearable devices
• Time and distance traveled from home

Outcome Measures

Primary Outcomes

| 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 |

Secondary Outcomes

| 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 |

Eligibility Criteria

Inclusion Criteria

• Receiving DBS therapy in the [globus pallidus](/cell-types/globus-pallidus) for treatment of PD
• Implanted with Medtronic Percept DBS system
• At least 3 months since initial activation of the neurostimulator
• For "At Home" experiment: participants with DBS settings that are sensing compatible

Exclusion Criteria

• History of musculoskeletal disorders significantly affecting motor task performance
• History of dementia or cognitive impairment
• Other significant medical conditions affecting participation

Significance for Parkinson's Disease

Understanding Levodopa-Resistant Signs

Many Parkinson's disease patients develop motor signs that no longer respond well to levodopa:

• Gait freezing: Sudden inability to initiate movement
• Postural instability: Balance and fall risk
• Speech dysfunction: Hypophonia, dysarthria
• Axial bradykinesia: Progressive slowing of axial movements

Toward Adaptive DBS

By correlating LFP biomarkers with motor symptoms, this research supports development of:

• Closed-loop DBS: Stimulation adjusted based on real-time neural activity
• Personalized programming: Optimizing DBS parameters for individual patients
• Remote monitoring: Using patient-activated recordings for clinical decision-making

Real-World Biomarkers

The study's focus on home-based LFP recordings and wearable device integration represents an important step toward:

• Continuous disease monitoring
• Early detection of progression
• Timely intervention before symptoms worsen

Related Pages

• [Parkinson's Disease](/diseases/parkinsons-disease)
• [Deep Brain Stimulation](/treatments/deep-brain-stimulation)
• [Globus Pallidus](/cell-types/globus-pallidus)
• [Subthalamic Nucleus](/cell-types/subthalamic-nucleus)
• [Adaptive Neurostimulation](/therapeutics/adaptive-deep-brain-stimulation)
• [Neural Oscillations in Parkinson's Disease](/mechanisms/neural-oscillations-parkinsons)
• [Levodopa-Resistant Motor Signs](/mechanisms/levodopa-resistant-motor-signs)
• [mPower Parkinson's Study](/clinical-trials/mpower-parkinson-study)

External Links

• [ClinicalTrials.gov - NCT05656586](https://clinicaltrials.gov/study/NCT05656586)
• [Udall Centers of Excellence - Parkinson's Foundation](https://www.parkinson.org/Research/Udall-Centers)
• [Medtronic Percept DBS System](https://www.medtronic.com/us-en/parkinsons-disease/percept-pc.html)
• [University of Minnesota Parkinson's Disease Research](https://med.umn.edu/)

References