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NCT Number: NCT06506058

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

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota, Movement Disorders Lab

Minneapolis, Minnesota, 55455, United States

Location status: Recruiting

Location contact

Madison Aasen, MS

CONTACT

[email protected]

612-505-8325

Sommer Amundsen-Huffmaster, PhD

CONTACT

Sommer Amundsen-Huffmaster, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Exclusion criteria

Exclusion criteria

(for all participants):

  • Any musculoskeletal disorder that affects the ability to stand or walk.
  • History of musculoskeletal disorders that significantly affect movement of lower limbs.
  • Uncorrected visual impairment that may affect participation or performance in the study.
  • History of visual and/or vestibular conditions that may affect participation or performance in the study.
  • Meet criteria for dementia with Lewy bodies, Multiple Systems Atrophy, Alzheimer's disease, dementia diagnosis, or other neurodegenerative disorder other than Parkinson's disease.
  • History of seizures, epilepsy, stroke, multiple sclerosis, or traumatic brain injury or other significant neurological disorders that may affect participation or performance in the study.
  • History of muscular conditions of the neck and back, including whiplash.
  • History of surgery on blood vessels, brain, or heart.
  • Unexplained, recurring headaches or concussion within the last six months.
  • Moderate to severe hearing impairment.
  • Subjects who are pregnant
  • 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 the results of the UBACC are inconclusive the individual will be further tested using the MacArthur Competency Assessment Tool for Clinical Research (McCAT-CR).

Additional exclusion criteria for EVS Experiments (Experiments 1 and 2):

  • History of motion sickness (as EVS can exacerbate motion sickness).
  • Intense physical exercise or consumption of alcohol in the 24 hours prior to any experiment that will include EVS testing.
  • Recent history of migraine headaches.
  • Intracranial metallic or magnetic devices.
  • Pacemaker or any implanted device.
  • Implanted deep brain stimulator or other neurosurgeries to treat PD.
  • Use of medications that can cause dizziness.

Additional exclusion criteria for Control Participants:

  • Presence of parkinsonism or cognitive impairment (including dementia or mild cognitive impairment).
  • Active central nervous system, systemic, psychiatric conditions or use of psychoactive medication that would adversely affect cognitive, neuropsychiatric, motor, or autonomic functioning.

Treatment and study plan

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).

Primary outcomes

  1. timing of trunk muscle torque production

    Time frame: one day

    Onset and offset times of the trunk muscle activity, relative to the start of the turn, as measured by electromyography sensors

  2. amplitude of trunk muscle torque production

    Time frame: one day

    Magnitudes of trunk muscle activity during the turn, as measured by electromyography sensors

  3. ground reaction force

    Time frame: up to 3 days

    The forces resulting from the participant pushing into the floor during turns and gait initiation, as measured by force plates under the feet

  4. center of pressure measures of turning and stepping

    Time frame: up to 3 days

    Participants will complete right/left 90 degree turns from standing on a pair of force plates (Kistler)

  5. body segmental angular velocity

    Time frame: one day

    The 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).

  6. motion onset

    Time frame: up to 3 days

    Time 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).

  7. total distance excursion

    Time frame: up to 3 days

    Distance 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).

  8. Movement amplitude

    Time frame: one day

    Size of the movements, as measured by the manipulandum during repetitive movements

  9. speed during the slow and fast epochs

    Time frame: one day

    Speed of the movements, as measured by the manipulandum during repetitive movements

  10. duration of freezing events

    Time frame: one day

    Length of time during which movements are drastically decreased in size or speed nears zero, as measured by the manipulandum during repetitive movements

  11. EVS coherence

    Time frame: up to 2 days

    • 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
    • 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Madison Aasen, MS

CONTACT

[email protected]

612-505-8325

Sommer Amundsen-Huffmaster, PhD

CONTACT

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Jul 17, 2024
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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