Transcutaneous Vibro-Acoustic Therapy in Parkinson Disease

NCT05962476 | Terminated

• 1 other identifier: HUM00231771
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Parkinson Disease

Keywords

transcutaneous vibro-acoustic therapy; anxiety

Outcome Measures

Primary Outcomes (18)

• Average Nighttime Heart Rate Variability

  Average heart rate variability during the night, as measured by Oura ring device (measured in s).

  after 90-120 days of intervention

• Paced Auditory Serial Addition Test score

  A measure of cognitive function that assesses auditory information processing speed and flexibility, scored as the total number correct out of 60. Higher scores indicate better performance.

  after 90-120 days of intervention

• Spielberger State-Trait Anxiety Inventory score

  40-item questionnaire to assess anxiety. Scores range from 40-160 with higher scores indicating greater severity of anxiety.

  after 90-120 days of intervention

• Hamilton Anxiety Scale score

  14-item questionnaire to evaluate severity of anxiety symptoms. Scores range from 0-56, with higher scores indicating greater severity of anxiety.

  after 90-120 days of intervention

• Hamilton Depression Scale score

  17-item questionnaire to assess the severity of depression symptoms. Scores range from 0-61, with higher scores indicating more severe depression.

  after 90-120 days of intervention

• Beck Depression Inventory score

  21-item scale to evaluate the severity of depression symptoms. Scores range from 0-63, with higher scores indicating more severe depression.

  after 90-120 days of intervention

• Beck Anxiety Inventory score

  21-item questionnaire to assess the severity of anxiety. Scores range from 0-63, with higher scores indicating greater anxiety.

  after 90-120 days of intervention

• Geriatric Depression Scale score

  15-item questionnaire scored from 0-15, with greater scores indicating greater severity of depression.

  after 90-120 days of intervention

• Short Activities-specific Balance Confidence Scale score

  16-item scale to assess confidence in balance while performing different tasks. Scores range from 0-100 with greater scores indicating greater confidence.

  after 90-120 days of intervention

• New Freezing of Gait Questionnaire score

  9-item questionnaire evaluating the severity of freezing of gait. Scores range from 0-29, with higher scores indicating more severe freezing of gait.

  after 90-120 days of intervention

• Instrumental Activities of Daily Living Scale score

  8-item questionnaire to assess functional independence. Scores range from 0-8, with higher scores indicating higher functioning.

  after 90-120 days of intervention

• Insomnia Severity Index score

  7-item scale to assess severity of insomnia. Scores range from 0-28, with higher scores indicating greater severity of insomnia.

  after 90-120 days of intervention

• Epworth Sleepiness Scale score

  8-item scale to assess daytime sleepiness. Scores range from 0-24, with higher scores indicating greater daytime sleepiness.

  after 90-120 days of intervention

• Fatigue severity Scale score

  9-item scale to measure the severity of fatigue. Scores range from 9-63, with higher scores indicating greater severity of fatigue.

  after 90-120 days of intervention

• Perceived Stress Scale score

  10-item questionnaire to evaluate perceived levels of stress. Scores range from 0-40, with greater scores indicating greater perceived stress.

  after 90-120 days of intervention

• Short Fall Efficacy Scale International score

  7-item questionnaire to evaluate fear of falling. Scores range from 7-28 with greater scores indicating greater fear of falling.

  after 90-120 days of intervention

• Fatigue Visual Analogue Scale score (Alternate form)

  Scored from 0-100, with higher score indicating greater fatigue.

  after 90-120 days of intervention

• Mayo Sleep Questionnaire Score on item 8

  Item 8 on the Mayo Sleep Questionnaire asks the participant to rate their general level of alertness over the past 3 weeks on a scale from 0 to 10, with 0 indicating they sleep all day and 10 indicating they are fully and normally awake.

  after 90-120 days of intervention

Study Arms (1)

Parkinson's Disease

EXPERIMENTAL

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

Device: Transcutaneous vibro-acoustic device

Interventions

Transcutaneous vibro-acoustic device DEVICE

Wearable device which sends low-frequency sound vibrations through the skin.

Also known as: Apollo Neuro

Parkinson's Disease

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with Parkinson's Disease (Hoehn and Yahr stage 2 or higher)
• Individuals on or off dopaminergic therapy
• Present of anxiety or panic disorder
• Fear of falling
• Understanding of use and care of smart phones and devices

You may not qualify if:

• Presence of significant dementia
• Disorders which may resemble PD, such as dementia with Lewy bodies, vascular dementia, normal pressure hydrocephalus, multiple system atrophy, corticobasal ganglionic degeneration, or toxic causes of parkinsonism.
• Patients with a cardiac pacemaker
• History of brain surgery or placement of a deep brain stimulator
• Psoriasis vulgaris (or other inflammatory skin condition) on or near skin where the vibro-acoustic device and sleep tracking ring will be donned.
• Patients on beta-blockers, benzodiazepines, antipsychotics, and stimulants (except for the treatment of attention deficit disorder/ADHD).
• Pregnancy
• Patients who begin cognitive behavioral therapy or a selective serotonin reuptake inhibitor (SSRI) medication for an anxiety disorder or other psychiatric disorder after the baseline clinical assessment.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

Domino's Farms

Ann Arbor, Michigan, 48105, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Anxiety Disorders

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Mental Disorders

Study Officials

• Prabesh Kanel, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Investigator

Study Record Dates

• First Submitted: June 29, 2023
• First Posted: July 27, 2023
• Study Start: August 9, 2023
• Primary Completion: August 9, 2023
• Study Completion: August 9, 2023
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)