Vibro-Acoustic Therapy for Parkinson's Disease

Overseen By Jacqueline Caswell

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Must not be taking: Beta-blockers, Benzodiazepines, Antipsychotics, Stimulants

Disqualifiers: Dementia, Cardiac pacemaker, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12-17 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to assist people with Parkinson's disease using a device that generates sound vibrations. The goal is to determine if transcutaneous vibro-acoustic therapy can improve sleep and reduce anxiety or fear of falling. Participants will use the device at night for about 3-4 months. The trial seeks individuals diagnosed with Parkinson's who experience anxiety or panic and can operate smartphones and other devices. As an unphased trial, it provides a unique opportunity to contribute to innovative research that could enhance the quality of life for Parkinson's patients.

Will I have to stop taking my current medications?

The trial excludes patients who are taking beta-blockers, benzodiazepines, antipsychotics, and stimulants (except for ADHD treatment). If you are on these medications, you may need to stop taking them to participate.

What prior data suggests that this vibro-acoustic therapy device is safe for people with Parkinson's disease?

In a previous study, early results suggested that vibro-acoustic therapy, which uses sound waves to improve movement symptoms, is generally safe. This therapy has been used before without major safety concerns. However, more research is needed to fully understand its effects. This trial is in an early stage, still exploring the therapy's effectiveness and safety. Prospective participants should consult their doctor to consider potential benefits and risks based on personal health needs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Transcutaneous Vibro-Acoustic Therapy for Parkinson's Disease because it offers a unique, non-invasive approach by using sound waves and vibrations to potentially improve symptoms. Unlike standard treatments like medication or deep brain stimulation, this method focuses on enhancing sleep and relaxation through the Apollo Neuro setting "Sleep and Renew," which might support better neurological health overnight. This therapy's innovative use of vibro-acoustic stimulation could provide a complementary option for managing Parkinson's, potentially improving quality of life without the side effects associated with medication.

What evidence suggests that this vibro-acoustic therapy is effective for Parkinson's disease?

Research suggests that vibration therapy, similar to sound-based therapy, might help reduce movement problems like stiffness and shaking in people with Parkinson's disease. Some studies have shown that sound stimulation can also improve these movement issues, making it a possible non-invasive treatment. Although evidence for improving balance and mobility with whole-body vibration remains inconclusive, there are hopeful signs. These findings suggest that using sound and vibration therapy on the skin, such as the Transcutaneous Vibro-Acoustic Therapy tested in this trial, could effectively address some symptoms of Parkinson's disease. ^{2 3 4 6 7}

Who Is on the Research Team?

Prabesh Kanel, PhD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for people with Parkinson's Disease at stage 2 or higher, who may or may not be on dopaminergic therapy. Participants should be able to use smart devices and have a fear of falling or anxiety disorders. It excludes those with certain skin conditions, on specific medications like beta-blockers, pregnant women, individuals with brain surgery history or pacemakers, and those diagnosed with dementia.

Inclusion Criteria

Fear of falling

Understanding of use and care of smart phones and devices

I have been diagnosed with anxiety or panic disorder.

Exclusion Criteria

Pregnancy

I have had brain surgery or a deep brain stimulator placed.

I started CBT or SSRI medication for anxiety or another psychiatric condition after my initial assessment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the vibro-acoustic device for 90-120 days, 6 hours at night on the Apollo Neuro setting 'Sleep and Renew'

12-17 weeks

Follow-up

Participants are monitored for changes in anxiety, nighttime heart rate variability, and fear of falling after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Transcutaneous Vibro-Acoustic Therapy

Trial Overview The study tests a vibro-acoustic therapy device called Apollo Neuro on individuals with Parkinson's Disease to see if it can improve their condition. This small pilot study will explore the potential benefits of this non-invasive treatment option.

How Is the Trial Designed?

Group I: Parkinson's Disease Experimental Treatment 1 Intervention

Participants will use the vibro-acoustic device 90-120 days for 6 hours at night on the Apollo Neuro setting "Sleep and Renew".

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Published Research Related to This Trial

Vibrotactile Feedback (VF) using a portable device did not significantly improve conversational vocal intensity in real-life settings for individuals with Parkinson's disease, based on a study involving 8 participants over 4 weeks.

There was no notable difference in vocal intensity between VF combined with Lee Silverman Voice Treatment (LSVT LOUD®) and VF alone, indicating that both treatments may have limited effectiveness in enhancing vocal intensity for these individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conversational Vocal Intensity in Parkinson's Disease: Treatment and Environmental Comparisons. Konnai, R., Van Harn, M., Silbergleit, A.[2023]

A new non-invasive treatment called vibrotactile coordinated reset (vCR) aims to improve motor and non-motor symptoms in Parkinson's disease (PD) patients by delivering gentle vibrations to the fingertips, with a 7-month study involving 30 participants to assess its efficacy.

The study will measure the effects of vCR on motor abilities using the Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) and other evaluations, with the goal of providing evidence for FDA clearance of this innovative therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Efficacy and Dosing of Vibrotactile Coordinated Reset Stimulation in Motor and Non-motor Symptoms of Parkinson's Disease: A Study Protocol. Pfeifer, KJ., Cook, AJ., Yankulova, JK., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05962476

Transcutaneous Vibro-Acoustic Therapy in Parkinson ... The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

2. trialx.com trialx.com/clinical-trials/listings/270694/transcutaneous-vibro-acoustic-therapy-in-parkinson-disease/

Transcutaneous Vibro-Acoustic Therapy in Parkinson ... Small exploratory pilot study to assess effects of a transcutaneous vibro-acoustic therapy device (Apollo Neuro) in people with Parkinson's disease (PD).

3. withpower.com withpower.com/trial/phase-parkinson-disease-6-2023-8ba77

Vibro-Acoustic Therapy for Parkinson's Disease Research suggests that vibration therapy, which is similar to vibro-acoustic therapy, may help improve motor symptoms like rigidity and tremor in Parkinson's ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10196363/

Binaural acoustic stimulation in patients with Parkinson's ... Acoustic stimulation can improve motor symptoms in Parkinson's disease (PD) and might therefore represent a potential non-invasive treatment option.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4100042/

The Effects of Whole Body Vibration on Mobility and Balance ... Overall, these investigations show some evidence for improving balance and mobility outcomes, but the effects are inconclusive. One condition where WBV may ...

6. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT05962476

Transcutaneous Vibro-Acoustic Therapy in Parkinson ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

7. frontiersin.org frontiersin.org/journals/physiology/articles/10.3389/fphys.2025.1693907/pdf

Transcutaneous auricular vagus nerve stimulation in ... Outcomes were extracted and narratively organized into three domains: safety, stimulation parameters, and efficacy. This narrative review was ...