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

Trial Summary

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 data supports the effectiveness of the treatment Transcutaneous 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 disease. A study using whole-body sound wave vibration showed improvements in motor control and functional outcomes, indicating potential benefits of this non-drug treatment. ^{1 2 3 4 5}

Is Vibro-Acoustic Therapy safe for humans?

Preliminary studies suggest that vibro-acoustic therapy, which uses sound waves to improve motor symptoms, is generally safe for humans. However, more research is needed to confirm its long-term safety. ^{1 2 3 6 7}

How does Vibro-Acoustic Therapy differ from other treatments for Parkinson's Disease?

Vibro-Acoustic Therapy is unique because it uses sound waves to deliver vibrations through the body, potentially improving motor symptoms like tremors and rigidity without medication. This non-drug approach may work by enhancing brain function and motor control, offering a complementary option to traditional drug treatments. ^{1 2 5 8 9}

What is the purpose of this trial?

This trial is testing a device that uses vibrations and sound waves on the skin to help people with Parkinson's disease. The goal is to see if it can reduce anxiety, improve nighttime heart rate, and lessen fear of falling.

Research Team

Prabesh Kanel, PhD

Principal Investigator

University of Michigan

Eligibility Criteria

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

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

Pregnancy

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

An Overview of Acoustic-Based Interventions to Improve Motor Symptoms in Parkinson's Disease. [2020]

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

Short-term effects of vibration therapy on motor impairments in Parkinson's disease. [2009]

3. 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]

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

Conversational Vocal Intensity in Parkinson's Disease: Treatment and Environmental Comparisons. [2023]

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

Focused Ultrasound: An Emerging Therapeutic Modality for Neurologic Disease. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Neuroprotective Effect of Low-Intensity Pulsed Ultrasound on the Mouse MPTP/MPP+ Model of Dopaminergic Neuron Injury. [2021]

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

The reduction in treatment efficiency at high acoustic powers during MR-guided transcranial focused ultrasound thalamotomy for Essential Tremor. [2019]

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

Sonogenetic-Based Neuromodulation for the Amelioration of Parkinson's Disease. [2021]

9. Switzerland 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. [2023]