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

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
University of Minnesota
Study ID
NCT06506058
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • EVS and EEG — DEVICE
    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).

Study Details

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.

Key Dates

Start date
Mar 24, 2025
Status verified
Mar 2026
Primary completion
Dec 1, 2028
Completion
Jan 1, 2029

Study Design

Enrollment
75 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: PD with FOG
    People with Parkinson's disease and freezing of gait: n = 25 in experiments 1 and 2, 20 in experiments 3 and 4. (Up to 90 participants, if each participant only volunteers for one study, however, the investigators anticipate a significant overlap and that most participants will volunteer for multiple experiments).
  • Experimental: PD without FOG
    n = 25 in experiments 1 and 2, 20 in experiments 3 and 4. (Up to 90 participants, as in Group 1.)
  • Active Comparator: Old adults matched controls
    (age- and sex-matched to the group with Parkinson's disease and freezing of gait): n = 25 in experiments 1 and 2, 20 in experiments 3 and 4. (Up to 90 participants, as in Group 1.)
  • Active Comparator: young adults matched controls
    Young adults (age 21-44) n = 25 in experiments 1 and 2, 20 in experiments 3 and 4. (Up to 90 participants, as in Group 1.)

Primary Outcome Measure

timing of trunk muscle torque production [ Time Frame: one day ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Minnesota, Movement Disorders LabMinneapolisMinnesota55455
Madison Aasen, MS
612-505-8325
Sommer Amundsen-Huffmaster, PhD
Sommer Amundsen-Huffmaster, PhD (PRINCIPAL_INVESTIGATOR)

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