What is the mechanism of action of this treatment?

The most common treatments for Parkinson's Disease (PD) include levodopa, dopamine agonists, MAO-B inhibitors, and amantadine. Levodopa is converted to dopamine in the brain, helping to replenish the diminished levels of this neurotransmitter, which is crucial for motor control. Dopamine agonists mimic dopamine by stimulating dopamine receptors, providing symptomatic relief. MAO-B inhibitors prevent the breakdown of brain dopamine, thereby prolonging its action. Amantadine promotes dopamine release and has anticholinergic effects, which can help manage tremors. These treatments are vital for PD patients as they address the core issue of dopamine deficiency, improving motor function and quality of life. Transcutaneous vibro-acoustic therapy, like the one studied in the Apollo Neuro trial, aims to provide non-pharmacological relief by using vibrations to stimulate sensory pathways, potentially offering an adjunctive benefit in managing PD symptoms.

What side effects are associated with this type of intervention?

Common treatments for Parkinson's Disease include levodopa, cholinesterase inhibitors, and tolcapone. Levodopa can cause nausea, somnolence, dizziness, headache, confusion, hallucinations, and orthostatic hypotension. Cholinesterase inhibitors, such as rivastigmine and donepezil, may lead to worsened tremor, nausea, and vomiting. Tolcapone is associated with liver toxicity and requires regular monitoring. Nonpharmacological approaches like transcutaneous vibro-acoustic therapy are generally well tolerated, with no significant device-related adverse events reported in studies.

What prior FDA approvals exist?

The FDA has approved several treatments for Parkinson's Disease, including pharmacologic options like levodopa, dopamine agonists, MAO-B inhibitors, and COMT inhibitors. Non-pharmacologic treatments such as deep brain stimulation (DBS) have also been approved. While there is limited information on FDA-approved transcutaneous vibro-acoustic therapy devices specifically for PD, the Apollo Neuro device represents an emerging non-invasive approach that aligns with the trend of exploring innovative, non-pharmacologic therapies for symptom management in PD.

What other types of research exist?

Promising novel alternatives to Apollo Neuro for Parkinson's Disease patients include: 1) Deep Brain Stimulation (DBS) targeting the anterior pallidum, which has shown significant improvement in akinetic symptoms. 2) Low-intensity focused ultrasound for neuromodulation, which is being explored for its potential clinical applications. 3) Transcranial magnetic stimulation (TMS), which has shown some efficacy in reducing symptoms in observational studies.

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Behavioural Intervention

Vibro-Acoustic Therapy for Parkinson's Disease

N/A

Recruiting

Led By Prabesh Kanel, PhD

Research Sponsored by University of Michigan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after 90-120 days of intervention

Awards & highlights

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this is an exploratory study using a non-invasive device, side effects are expected to be minimal but could include discomfort where the device touches the skin or possible interference with sleep patterns.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ after 90-120 days of intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~after 90-120 days of intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and after 90-120 days of intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Average Nighttime Heart Rate Variability

Beck Anxiety Inventory score

Beck Depression Inventory score

+15 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Parkinson's DiseaseExperimental Treatment1 Intervention

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

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Parkinson's Disease (PD) include levodopa, dopamine agonists, MAO-B inhibitors, and amantadine. Levodopa is converted to dopamine in the brain, helping to replenish the diminished levels of this neurotransmitter, which is crucial for motor control. Dopamine agonists mimic dopamine by stimulating dopamine receptors, providing symptomatic relief. MAO-B inhibitors prevent the breakdown of brain dopamine, thereby prolonging its action. Amantadine promotes dopamine release and has anticholinergic effects, which can help manage tremors. These treatments are vital for PD patients as they address the core issue of dopamine deficiency, improving motor function and quality of life. Transcutaneous vibro-acoustic therapy, like the one studied in the Apollo Neuro trial, aims to provide non-pharmacological relief by using vibrations to stimulate sensory pathways, potentially offering an adjunctive benefit in managing PD symptoms.

Lesion therapy for Parkinson's disease and other movement disorders: update and controversies.

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Who is running the clinical trial?

University of MichiganLead Sponsor

1,818 Previous Clinical Trials

6,387,608 Total Patients Enrolled

Prabesh Kanel, PhDPrincipal InvestigatorUniversity of Michigan

Media Library

Transcutaneous Vibro-Acoustic Therapy (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05962476 — N/A

Parkinson's Disease Research Study Groups: Parkinson's Disease

Parkinson's Disease Clinical Trial 2023: Transcutaneous Vibro-Acoustic Therapy Highlights & Side Effects. Trial Name: NCT05962476 — N/A

Transcutaneous Vibro-Acoustic Therapy (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05962476 — N/A

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