Electrical Vestibular Stimulation for Parkinson's Disease

Overseen By Sommer Amundsen-Huffmaster, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Must not be taking: Psychoactive, Dizziness-inducing

Disqualifiers: Musculoskeletal disorders, Neurodegenerative disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes participants using medications that can cause dizziness. It's best to discuss your specific medications with the trial team.

Is Electrical Vestibular Stimulation safe for humans?

Electrical Vestibular Stimulation (EVS) is considered to have a favorable safety profile, meaning it is generally safe for humans, as it is non-invasive and can be administered at home. ^{1 2 3 4 5}

How does Electrical Vestibular Stimulation differ from other treatments for Parkinson's Disease?

Electrical Vestibular Stimulation (EVS) is unique because it is a non-invasive treatment that uses electrical currents to stimulate the vestibular system, which can influence brain activity and improve motor and non-motor symptoms in Parkinson's Disease. Unlike traditional medications, EVS can be administered at home and has a favorable safety profile, making it a promising complementary therapy. ^{1 3 6 7 8}

What data supports the effectiveness of the treatment Electrical Vestibular Stimulation (EVS) for Parkinson's Disease?

Research suggests that Electrical Vestibular Stimulation (EVS) can improve brain connectivity and reduce symptoms in Parkinson's Disease. Studies have shown that similar vestibular stimulation methods can help with both movement and non-movement symptoms in Parkinson's patients. ^{1 2 3 5 6}

Who Is on the Research Team?

Sommer Huffmaster, PhD

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for adults aged 40-80 with Parkinson's Disease (PD), both with and without Freezing of Gait (FOG). They must be able to walk independently. It also includes healthy older adults matched by age and sex, as well as young adults aged 21-44, who can all ambulate without assistance and manage daily activities.

Inclusion Criteria

I am between 40 and 80 years old.

I can walk 50 meters without help or a device.

I have Parkinson's disease, with or without difficulty walking.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Vestibular Activity Assessment

Participants undergo electrical vestibular stimulation (EVS) to assess vestibular contributions to movement transitions

up to 3 days

Multiple visits (in-person)

Cortical Activity Assessment

Participants undergo electroencephalography (EEG) to assess cortical contributions to movement transitions

up to 3 days

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after assessments

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Electrical Vestibular Stimulation (EVS)
• Electroencephalography (EEG)

Trial Overview The study tests how the vestibular system and brain activity contribute to movement issues in PD. It uses electrical vestibular stimulation (EVS) to stimulate balance responses and electroencephalography (EEG) to record brain activity during movements like standing, walking, turning, or changing pace.

How Is the Trial Designed?

Group I: PD without FOG Experimental Treatment 1 Intervention

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

Group II: PD with FOG Experimental Treatment 1 Intervention

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 III: Old adults matched controls Active Control 1 Intervention

(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 IV: young adults matched controls Active Control 1 Intervention

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.)

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Citations

1. England pubmed.ncbi.nlm.nih.gov

Caloric and galvanic vestibular stimulation for the treatment of Parkinson's disease: rationale and prospects. [2021]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Ocular torsion responses to electrical vestibular stimulation in vestibular schwannoma. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Galvanic Vestibular Stimulation (GVS) effects on impaired interhemispheric connectivity in Parkinson's Disease. [2020]

4. Netherlands pubmed.ncbi.nlm.nih.gov

A durable gain in motor and non-motor symptoms of Parkinson's Disease following repeated caloric vestibular stimulation: A single-case study. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Effectiveness of electrical vestibular nerve stimulation on the range of motion in patients with Parkinson's disease. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Caloric vestibular stimulation for the management of motor and non-motor symptoms in parkinson's disease: Intention-to-treat data. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Current perspectives on galvanic vestibular stimulation in the treatment of Parkinson's disease. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Abnormal Phase Coupling in Parkinson's Disease and Normalization Effects of Subthreshold Vestibular Stimulation. [2020]