Recruiting

Observational Study

Sponsor:

University of Minnesota

Code:

NCT06506058

Conditions

Parkinson Disease

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Accepted

Interventions

EVS and EEG

Study Details

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.

Conditions

Parkinson Disease

Study ID

NCT06506058

Start date

Mar 24, 2025

Status verified date

Mar, 2026

Completion date

Jan 1, 2029

Anticipated

Primary completion date

Dec 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

75 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

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.)

Interventions

EVS 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).

Primary outcome measure

  • timing of trunk muscle torque production [ Time Frame: one day ]
  • amplitude of trunk muscle torque production [ Time Frame: one day ]
  • ground reaction force [ Time Frame: up to 3 days ]
  • center of pressure measures of turning and stepping [ Time Frame: up to 3 days ]
  • body segmental angular velocity [ Time Frame: one day ]
  • motion onset [ Time Frame: up to 3 days ]
  • total distance excursion [ Time Frame: up to 3 days ]
  • Movement amplitude [ Time Frame: one day ]
  • speed during the slow and fast epochs [ Time Frame: one day ]
  • duration of freezing events [ Time Frame: one day ]
  • EVS coherence [ Time Frame: up to 2 days ]

Central Contacts and Locations

Central contacts

Locations

University of Minnesota, Movement Disorders Lab

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Principal Investigator:

Sommer Amundsen-Huffmaster, PhD

More Information

Sponsor

University of Minnesota

Last update posted

Mar 19, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Minnesota on 2026-03-19.