At-home taVNS for Parkinson's Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
The goal of this clinical trial is to learn if taVNS works to treat symptoms of Parkinson's Disease in adults. It will also learn about the feasibility and preliminary efficacy of taVNS administered at home by the participant.
The main questions it aims to answer are:
1. Is at-home taVNS feasible and effective for treating symptoms of Parkinson's Disease? How often are participants completing the stimulation protocol? What are the side effects of stimulation experienced by participants? How do participants rate the experience of taVNS sessions at home? How do participants' scores on assessments and questionnaires change with taVNS treatments?
2. How does taVNS impact connections between neural networks in the brain of patients with Parkinson's Disease at rest?
Participants will:
* Have a baseline MRI scan to take images of their brain.
* Complete a series of assessments and questionnaires to evaluate their Parkinson's Disease motor symptoms, cognitive and neuropsychiatric symptoms, and other non-motor symptoms.
* Have an initial taVNS session where their threshold to perceive the stimulation will be measured. This value will be used to stimulate each participant at a specific dose relative to their individual perception of stimulation.
* Be trained on how to use the taVNS device and system and have one 1-hour taVNS session where their vitals will be monitored.
* Self-administer 1-hour daily taVNS sessions for 8 weeks at-home, complete tolerability questionnaires, and weekly remote check-ins with study staff.
* After 4-weeks of at-home taVNS, participants will come in-person to repeat the questionnaires and assessments from the first visit.
* Following the 8 weeks of taVNS sessions, participants will repeat the MRI scan, assessments and questionnaires from visit 1.
* Participants will complete questionnaires remotely 1 month following their last taVNS sessions.
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants undergo a baseline MRI scan and complete assessments and questionnaires to evaluate Parkinson's Disease symptoms.
Initial taVNS Session
Participants have an initial taVNS session to measure their threshold for stimulation and are trained on device usage.
At-home taVNS Treatment
Participants self-administer 1-hour daily taVNS sessions for 8 weeks at home, with weekly remote check-ins.
Midpoint Assessment
Participants repeat questionnaires and assessments after 4 weeks of at-home taVNS.
Post-treatment Assessment
Following 8 weeks of taVNS sessions, participants repeat the MRI scan, assessments, and questionnaires.
Follow-up
Participants complete questionnaires remotely 1 month following their last taVNS sessions.
What Are the Treatments Tested in This Trial?
Interventions
- transcutaneous auricular nerve stimulation
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
one in-person taVNS session followed by 8 weeks of at-home taVNS sessions
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medical University of South Carolina
Lead Sponsor
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.