Clinical trial NCT06848205: Percept Transitions in FOG and PD
Official title: Basal Ganglia Contributions to Transitions in Freezing of Gait and Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Freezing of Gait
Parkinson Disease
Keywords: FOG
PD
Freezing of Gait
Parkinson disease
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2025-02-26
Enrollment: 36
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In the second experiment: we will compare LFPs during the successful movement transitions vs. freezing-events during a FOG provocation course in people with FOG only.
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

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.

Primary outcomes:
measure: Quantification of the anticipatory postural adjustments magnitudes (cm)
timeFrame: During the intervention
measure: Quantification of the anticipatory postural adjustments duration (sec)
timeFrame: During the intervention
measure: Step characteristics of the first two steps, length (cm)
timeFrame: During the intervention
measure: Step characteristics of the first two steps, width (cm)
timeFrame: During the intervention
measure: Step characteristics of the first two steps, duration (sec)
timeFrame: During the intervention
measure: The coherence magnitudes between the cortex and globus pallidus (dB)
timeFrame: During the intervention
measure: The coherence magnitudes between the cortex and EMG (dB)
timeFrame: During the intervention
measure: The coherence magnitudes between the globus pallidus and EMG (dB)
timeFrame: During the intervention
measure: Number of freezing episodes
timeFrame: During the intervention
measure: Rapid Alternating Movements of Wrist Pronation/Supination (degrees)
timeFrame: During the intervention
measure: Rapid Alternating Movements of Supination or Ankle plantar/dorsi-flexion (degrees)
timeFrame: During the intervention
measure: Peak power of local field potential oscillations (dB)
timeFrame: During the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota, Movement Disorders Lab
state: Minnesota
Study officials:
References: