Percept Transitions in FOG and PD

Official title

Basal Ganglia Contributions to Transitions in Freezing of Gait and Parkinson's Disease

Overview

The purpose of this research is to examine the possible causes and signs of freezing of gait (FOG) secondary to Parkinson's disease (PD). To achieve this, the study will use the novel (on-label and FDA-approved) local field potential (LFP) measuring capability of the Medtronic Percept™ deep brain stimulation (DBS) system to compare oscillatory activity in people who have Parkinson's disease, with and without freezing of gait (FOG). This will be conducted as three separate experiments, participants may volunteer for one or more experiments: Experiment 1: The first experiment will compare LFPs during gait initiation with and without a cue, in people with (PD+FOG) and without FOG (PD-FOG). Experiment 2: The second experiment will compare LFPs during the successful movement transitions vs. freezing-events during a FOG provocation course in people with FOG. Experiment 3: The third experiment will compare LFPs during rapid alternating movements of the wrist and/or foot, in people with and without FOG

Detailed description

The purpose of this research is to examine the underlying pathophysiology and biomarkers of freezing of gait (FOG) and cueing-evoked improvements. This protocol will use the novel (on-label, FDA-approved) local field potential (LFP)-measuring capability of the Medtronic Percept™ deep brain stimulation (DBS) system to compare oscillatory activity in people who have Parkinson's disease (PD), with and without freezing of gait (FOG). This will be conducted as three separate experiments, participants may volunteer for one or more experiments:

Experiment 1: The first experiment will compare LFPs during gait initiation with and without a cue, in people with (PD+FOG) and without FOG (PD-FOG).

Experiment 2: In the second experiment, the investigators will compare LFPs during the successful movement transitions vs. freezing-events during a FOG provocation course in people with FOG.

Experiment 3: In the third experiment, the investigators will compare LFPs during rapid alternating movements of the wrist and/or foot, in people with and without FOG.

Interventions

• Other OFF Parkinson's Medication(s)
  Participants will be asked to withhold Parkinson's medications 12 hours prior to their testing visit (if extended-release Parkinson's medications are taken by the participant, they will be asked to withhold these for 24 hours prior to their testing visit).
• Other OFF Deep Brain Stimulation
  Participants will have their deep brain stimulation turned off at the beginning of their testing visit.

Primary outcome measures

• Quantification of the anticipatory postural adjustments magnitudes (cm) [Time frame: During the intervention]
• Quantification of the anticipatory postural adjustments duration (sec) [Time frame: During the intervention]
• Step characteristics of the first two steps, length (cm) [Time frame: During the intervention]
• Step characteristics of the first two steps, width (cm) [Time frame: During the intervention]
• Step characteristics of the first two steps, duration (sec) [Time frame: During the intervention]
• The coherence magnitudes between the cortex and globus pallidus (dB) [Time frame: During the intervention]
• The coherence magnitudes between the cortex and EMG (dB) [Time frame: During the intervention]
• The coherence magnitudes between the globus pallidus and EMG (dB) [Time frame: During the intervention]
• Number of freezing episodes [Time frame: During the intervention]
• Rapid Alternating Movements of Wrist Pronation/Supination (degrees) [Time frame: During the intervention]

Eligibility criteria

Inclusion criteria

• Diagnosis of idiopathic PD.
• Age 21-75 (see Inclusion of Individuals across the Lifespan for justification of age range).
• Able to ambulate independently without the use of an assistive device (e.g. cane) for 50 meters.
• Implanted Medtronic Percept TM Device.
• At least 3 months since the initial activation of the neurostimulator.
• Undervalued, under-represented, or disenfranchised social group may be included.
• Active members of the military (service members), DoD personnel (including civilian employees) may be included.
• Individual or group that is disadvantaged in the distribution of social goods and services such as income, housing, or healthcare may be included.

Exclusion criteria

• Meet criteria for dementia with Lewy bodies, Multiple Systems Atrophy, Alzheimer's disease, or other neurodegenerative disorder.
• History of seizures or other significant neurological disorders that may affect participation or performance in the study.
• History of musculoskeletal disorders that significantly affect walking or movement of limb(s) that would affect the participation in the experimental task (Participants will be excluded from that task, but may participate in other tasks, for example, may be excluded from Experiment 1 if the disorder affects walking, but may still participate in Experiment 3).
• History of muscular conditions of the neck and back, including whiplash that would affect walking experiments.
• History of visual and/or vestibular conditions that may affect participation or performance in the study.
• Reduced capacity to consent. This will be assessed using a 2-stage process. Initially, participants will be tested using the University of California, San Diego, Brief Assessment of Capacity to Consent (UBACC). If concerns are raised from the UBACC test, the individual will be further tested using the MacArthur Competency Assessment Tool.
• Pregnant people.
• Post-operative complications or adverse effects (e.g. ON stimulation dystonia) that affect patient safety or confound the experiment.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Basic science

Study locations

United States · 1 center

• University of Minnesota, Movement Disorders Lab — Minneapolis

Identifiers

NCT: NCT06848205 · NEUR-2024-33357 · STUDY00023279

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗