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Vestibular and Cortical Contributions to Transitions in Freezing of Gait in Parkinson's Disease

Vestibular and Cortical Contributions to Transitions in Freezing of Gait in Parkinson's Disease

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06506058
Enrollment
75
Registered
2024-07-17
Start date
2025-03-24
Completion date
2029-01-01
Last updated
2026-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

Brief summary

Currently, there is a lack of comprehensive knowledge about the role of vestibulospinal drive and cortical activity during self-initiated movement transitions in older adults and people with PD (both with and without FOG). This set of experiments has two primary purposes: to (1) understand the pathological neurophysiology underlying freezing of gait (FOG) during movement transitions and FOG-inducing movements and (2) identify neurological biomarkers associated with FOG and FOG-inducing movements. To achieve this, the investigators will assess vestibular activity using the noninvasive neuromodulation technique of electrical vestibular stimulation (EVS, Experiments 1 and 2) and assess cortical activity by recording via electroencephalography (EEG, Experiments 3 and 4, no stimulation included). These experiments will investigate the vestibular (EVS Experiments) and cortical (EEG experiments) contributions to movement transitions during standing, walking, turning, and changing movement rates. Upon completion of this project, the investigators expect to provide a new understanding of key neural systems (vestibular and cortical) involved in the pathogenesis of movement impairment and freezing episodes during movement transitions including gait initiation, turning, and changing movement rates, in people with PD. An increased understanding of the temporal dynamics of systems involved in FOG and FOG-inducing movements could later guide the development and delivery of novel interventions (e.g. closed-loop deep brain stimulation \[DBS\] or non-invasive brain stimulation) to decrease the incidence and severity of FOG episodes, reducing fall risk and morbidity.

Interventions

DEVICEEVS and EEG

The participant can choose to participate in one or more of the following experiments. (Any two of these visits will be separated by at least one week.) Experiment 1: EVS during gait initiation (forward stepping, 2 visits) Experiment 2: EVS during turning (1 visit) Experiment 3: EEG during gait initiation (forward stepping, 1 visit) Experiment 4: EEG during RAMS (1 visit) vestibular activity will be assessed using the noninvasive neuromodulation technique of electrical vestibular stimulation (EVS, Experiments 1 and 2) and cortical activity will be assessed by recording via electroencephalography (EEG, Experiments 3 and 4, no stimulation included).

Sponsors

University of Minnesota
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)

Intervention model description

The study will use a cross-sectional design to examine the effects of group (PD with FOG vs. PD without FOG vs. matched controls; older adults vs. younger adults)

Eligibility

Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

Participants with Parkinson's disease (with and without Freezing of Gait) * Diagnosis of idiopathic PD. * Age 40-80 years. * Able to ambulate independently without the use of an assistive device (e.g. cane) for 50 meters. Healthy Older Adults (Control participants) * Age 40-80 years (this group will be age- and sex-matched to the PD and FOG group). * Able to ambulate independently without the use of an assistive device (cane or walker). * Normal capacity to perform complex activities of daily living independently based on informant or physician report. Healthy Young Adults * Age 21-44 years (this group will be sex-matched to the PD and FOG group) * Able to ambulate independently without the use of an assistive device (cane or walker)

Design outcomes

Primary

MeasureTime frameDescription
Movement amplitudeone daySize of the movements, as measured by the manipulandum during repetitive movements
speed during the slow and fast epochsone daySpeed of the movements, as measured by the manipulandum during repetitive movements
duration of freezing eventsone dayLength of time during which movements are drastically decreased in size or speed nears zero, as measured by the manipulandum during repetitive movements
timing of trunk muscle torque productionone dayOnset and offset times of the trunk muscle activity, relative to the start of the turn, as measured by electromyography sensors
amplitude of trunk muscle torque productionone dayMagnitudes of trunk muscle activity during the turn, as measured by electromyography sensors
ground reaction forceup to 3 daysThe forces resulting from the participant pushing into the floor during turns and gait initiation, as measured by force plates under the feet
center of pressure measures of turning and steppingup to 3 daysParticipants will complete right/left 90 degree turns from standing on a pair of force plates (Kistler)
body segmental angular velocityone dayThe speed at which different body parts (e.g., head, thoracic spine, etc.) rotate during a turn, as measured by 24 reflective markers at various bony landmarks on the head, trunk, pelvis, and lower extremities, used to capture the whole-body kinematic motion via optical motion capture various bony landmarks on their head, trunk, pelvis, and lower extremities to capture whole-body kinematic motion via optical motion capture (Simi Motion).
motion onsetup to 3 daysTime of initial movement of the body, as measured by 24 reflective markers at various bony landmarks on the head, trunk, pelvis, and lower extremities, used to capture the whole-body kinematic motion via optical motion capture various bony landmarks on their head, trunk, pelvis, and lower extremities to capture whole-body kinematic motion via optical motion capture (Simi Motion).
total distance excursionup to 3 daysDistance moved, as measured by 24 reflective markers at various bony landmarks on the head, trunk, pelvis, and lower extremities, used to capture the whole-body kinematic motion via optical motion capture various bony landmarks on their head, trunk, pelvis, and lower extremities to capture whole-body kinematic motion via optical motion capture (Simi Motion).
EVS coherenceup to 2 days1. A measure of the correlation between electrically evoked vestibular stimulation and the subsequent motor responses in the trunk and leg muscles prior to initiation of forward stepping or turning 2. Coherence between trunk or leg muscle activation and EVS, coherence between ground reaction forces and EVS electrically evoked vestibular stimulation and the subsequent motor responses in the trunk and leg muscles prior to initiation of forward stepping coherence between trunk/leg muscle activation and EVS, coherence between ground reaction forces and EVS.

Countries

United States

Contacts

CONTACTMadison Aasen, MS
aasen056@umn.edu612-505-8325
CONTACTSommer Amundsen-Huffmaster, PhD
PRINCIPAL_INVESTIGATORSommer Huffmaster, PhD

University of Minnesota

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026