Parkinson DiseaseNCT06506058
Vestibular and Cortical Contributions to Transitions in Freezing of Gait in Parkinson's Disease
A study testing EVS and EEG in people with Parkinson Disease, run by University of Minnesota at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- EVS and EEG
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2025to 1 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
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- 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)
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sommer Amundsen-Huffmaster, PhD contact
United States1 site, 1 recruiting
- Recruiting
University of Minnesota, Movement Disorders Lab
Minneapolis, Minnesota, 55455
Madison Aasen, MS, 612-505-8325, aasen056@umn.edu
Sommer Amundsen-Huffmaster, PhD
About this study
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
- Being tested
- EVS and EEG
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVS and EEGDevice
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 group | Role | What they receive |
|---|---|---|
| PD with FOG | Experimental | 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). Receives: Device: EVS and EEG |
| PD without FOG | Experimental | n = 25 in experiments 1 and 2, 20 in experiments 3 and 4. (Up to 90 participants, as in Group 1.) Receives: Device: EVS and EEG |
| Old adults matched controls | Active comparator | (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.) Receives: Device: EVS and EEG |
| young adults matched controls | Active comparator | 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.) Receives: Device: EVS and EEG |
What is being measured
The primary outcome is the main question the study is designed to answer.
timing of trunk muscle torque production
Onset and offset times of the trunk muscle activity, relative to the start of the turn, as measured by electromyography sensors
Measured: one day
amplitude of trunk muscle torque production
Magnitudes of trunk muscle activity during the turn, as measured by electromyography sensors
Measured: one day
ground reaction force
The forces resulting from the participant pushing into the floor during turns and gait initiation, as measured by force plates under the feet
Measured: up to 3 days
center of pressure measures of turning and stepping
Participants will complete right/left 90 degree turns from standing on a pair of force plates (Kistler)
Measured: up to 3 days
body segmental angular velocity
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).
Measured: one day
motion onset
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).
Measured: up to 3 days
total distance excursion
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).
Measured: up to 3 days
Movement amplitude
Size of the movements, as measured by the manipulandum during repetitive movements
Measured: one day
speed during the slow and fast epochs
Speed of the movements, as measured by the manipulandum during repetitive movements
Measured: one day
duration of freezing events
Length of time during which movements are drastically decreased in size or speed nears zero, as measured by the manipulandum during repetitive movements
Measured: one day
EVS coherence
- 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.
Measured: up to 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start24 Mar 2025
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sommer Huffmaster, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06506058
- Sponsor's protocol ID
- NEUR-2024-33325
- Status last verified
- Mar 2026
- First submitted
- 13 Jun 2024
- Last updated
- 19 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vestibular and Cortical Contributions to Transitions in Freezing of Gait in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06506058
- Acronym / sponsor ID
- NEUR-2024-33325
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 24 Mar 2025 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 17 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- 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)
| Arm | Type | Receives |
|---|---|---|
| PD with FOG | Experimental | Device: EVS and EEGPeople 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). |
| PD without FOG | Experimental | Device: EVS and EEGn = 25 in experiments 1 and 2, 20 in experiments 3 and 4. (Up to 90 participants, as in Group 1.) |
| Old adults matched controls | Active comparator | Device: EVS and EEG(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.) |
| young adults matched controls | Active comparator | Device: EVS and EEGYoung 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.) |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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).
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EVS and EEGThe 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). | Device | Old adults matched controls, PD with FOG, PD without FOG, young adults matched controls |
Primary outcome
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
amplitude of trunk muscle torque production
Time frame: one day
Magnitudes of trunk muscle activity during the turn, as measured by electromyography sensors
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
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)
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).
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).
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).
Movement amplitude
Time frame: one day
Size of the movements, as measured by the manipulandum during repetitive movements
speed during the slow and fast epochs
Time frame: one day
Speed of the movements, as measured by the manipulandum during repetitive movements
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
EVS coherence
Time frame: up to 2 days
1. 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sommer Amundsen-Huffmaster, PhD contact
Sommer Huffmaster, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EVS and EEG in people with Parkinson Disease, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Madison Aasen, MS (612-505-8325, aasen056@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
timing of trunk muscle torque production (time frame: one day). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.