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

NCT ID: NCT06506058

Last Updated: 2025-03-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-24
• Study Completion Date: 2029-01-01

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 Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

EVS and EEG

Intervention Type: 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).

PD without FOG

n = 25 in experiments 1 and 2, 20 in experiments 3 and 4. (Up to 90 participants, as in Group 1.)

Group Type: EXPERIMENTAL

EVS and EEG

Intervention Type: 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).

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.)

Group Type: ACTIVE_COMPARATOR

EVS and EEG

Intervention Type: 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).

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.)

Group Type: ACTIVE_COMPARATOR

EVS and EEG

Intervention Type: 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).

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).

Intervention Type: DEVICE

Eligibility Criteria

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

• 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).

• 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.

• 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sommer Huffmaster, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota, Movement Disorders Lab

Minneapolis, Minnesota, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Madison Aasen, MS

Role: CONTACT

aasen056@umn.edu

612-505-8325

Sommer Amundsen-Huffmaster, PhD

Role: CONTACT

Facility Contacts

Madison Aasen, MS

Role: primary

aasen056@umn.edu

612-505-8325

Sommer Amundsen-Huffmaster, PhD

Role: backup

Other Identifiers

NEUR-2024-33325

Identifier Type: -

Identifier Source: org_study_id