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?

This trial examines how certain brain systems affect movement problems in people with Parkinson's disease, particularly those experiencing "freezing of gait" (when individuals feel stuck and can't move their feet). Researchers will use electrical vestibular stimulation (EVS), a gentle electrical signal to the balance system in the ears, to study its role in movement transitions like starting to walk, turning, or changing speeds. They will also record brain activity with electroencephalography (EEG) to understand what occurs in the brain during these movements. This trial includes people with Parkinson's who can walk short distances without assistance and sometimes feel like their feet are stuck, as well as healthy adults who can walk independently. The goal is to discover new ways to reduce these movement issues in the future. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could lead to innovative treatments for movement issues.

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.

What prior data suggests that electrical vestibular stimulation is safe for people with Parkinson's disease?

Research has shown that electrical vestibular stimulation (EVS) has been explored for its effects on Parkinson's disease. In these studies, EVS has shown promise in reducing movement problems in people with Parkinson's.

Safety information indicates that EVS is generally well-tolerated, with most people experiencing no major side effects. The treatment has been used to improve motor functions, and participants have not experienced significant negative effects. This suggests it might be a safe option for those considering joining trials related to Parkinson's disease.

These findings are based on current research, and joining a study always involves some level of risk. It's important to talk to a healthcare provider to understand what participating in a trial means. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Electrical Vestibular Stimulation (EVS) for Parkinson's Disease because it offers a novel, non-invasive way to potentially improve symptoms, especially for those experiencing freezing of gait (FOG). Unlike standard treatments like Levodopa or deep brain stimulation, which focus on dopamine levels or brain activity, EVS targets the vestibular system, which is involved in balance and spatial orientation. This unique approach might help alleviate motor symptoms without the side effects associated with traditional medications. Additionally, using Electroencephalography (EEG) alongside EVS allows researchers to monitor brain activity in real-time, offering insights into how EVS impacts the neural pathways involved in Parkinson's.

What evidence suggests that electrical vestibular stimulation is effective for Parkinson's disease?

This trial will evaluate the effects of Electrical Vestibular Stimulation (EVS) on various groups, including those with Parkinson's disease (PD) with and without freezing of gait (FOG), as well as matched control groups. Research has shown that EVS can enhance movement in people with PD. In earlier studies, patients experienced quicker reaction times and improved movement after receiving EVS. Another study suggested that EVS might also aid thinking and memory by slowing brain changes related to PD. Additionally, EVS has positively affected blood pressure, potentially improving overall health. Overall, EVS presents a promising non-invasive option for enhancing both movement and cognition in people with PD. ^{1 6 7 8 9}

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. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36209355/

Effectiveness of electrical vestibular nerve stimulation on ... The study results confirm the improvement of motor activities of patients with PD followed by vestibular stimulation.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36103719/

Effectiveness of electrical vestibular nerve stimulation as ... Results: There was a significant improvement in both auditory and visual reaction time of right and left-hand responses. Also, significant ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04450550

Study Details | NCT04450550 | Electrical Vestibular Nerve ... So long term vestibular stimulation may be effective in enhancing cognition by reducing the cognitive, neurodegenerative, neuroinflammatory changes and ...

4. ajmsjournal.info ajmsjournal.info/index.php/AJMS/article/download/4384/3627/18360

Immediate effect of electrical vestibular stimulation on ... Conclusion: The study results support that a single session of electrical vestibular stimulation has beneficial effects on blood pressure and ...

5. mdpi.com mdpi.com/2075-4426/14/9/933

A Novel Device-Aided Non-Invasive Therapeutic Option Therapeutic non-invasive vestibular stimulation is a relatively modern concept that may potentially improve a broad range of motor and nonmotor symptoms of PD.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11432959/

Vestibular Neurostimulation for Parkinson's Disease: A Novel ... Here, we review previous studies supporting the therapeutic potential of vestibular stimulation for the treatment of PD and discuss ongoing clinical trials and ...

7. withpower.com withpower.com/trial/phase-parkinson-disease-8-2024-96b18

Electrical Vestibular Stimulation for Parkinson's Disease Trial Overview The study tests how the vestibular system and brain activity contribute to movement issues in PD. It uses electrical vestibular stimulation (EVS) ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0306452224003683

Galvanic vestibular stimulation modulates EEG markers of ... We recently showed that vestibular stimulation can produce a long-lasting alleviation of motor features in Parkinson's disease.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12109273/

Individualising Galvanic Vestibular Stimulation Further ... These findings suggest that GVS can yield significant motor improvements in individuals with PD. Furthermore, individualised optimisation of ...