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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
Study Summary
This trial tested a device to treat Parkinson's; results showed it had positive effects.
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.Check my eligibility
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.See study design
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Average Nighttime Heart Rate Variability
Beck Anxiety Inventory score
Beck Depression Inventory score
+15 moreTrial 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".
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Who is running the clinical trial?
University of MichiganLead Sponsor
1,798 Previous Clinical Trials
6,378,128 Total Patients Enrolled
Prabesh Kanel, PhDPrincipal InvestigatorUniversity of Michigan
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.I have been diagnosed with anxiety or panic disorder.I have been diagnosed with severe dementia.I am currently taking or not taking medication for dopamine regulation.My Parkinson's Disease is at stage 2 or higher.I am taking medication for ADHD but not on beta-blockers, benzodiazepines, antipsychotics, or stimulants for other conditions.My condition is not due to other disorders similar to Parkinson's.I have psoriasis or a similar skin condition where the study device will be worn.
Research Study Groups:
This trial has the following groups:- Group 1: Parkinson's Disease
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still opportunities to partake in this clinical experiment?
"Indeed, the clinicaltrials.gov website attests to this medical trial's ongoing recruitment efforts which began on August 9th 2023 and were last updated a day later. At present, 10 participants from 1 facility are required for the study."
Answered by AI
How many individuals have signed up to participate in this research investigation?
"Yes, the information available on clinicaltrials.gov verifies that this research project is still open for participant recruitment. It was first published on August 9th 2023 and has been updated as recently as August 10th 2023. The investigators are hoping to find 10 volunteers from a single site."
Answered by AI
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