๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-06-11

At-home taVNS for Neurorehabilitation in Parkinson's Disease (NCT07536022)

Developing At-home taVNS for Neurorehabilitation in Parkinson's Disease

๐ŸŸข Recruiting Observational / Diagnostic โš™๏ธ Medical Device Protocol Sponsor: Medical University of South Carolina

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Medical University of South Carolina โ€” Charleston, South Carolina

Age range: 40 Years to 85 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (1 Sites)

  • Medical University of South Carolina โ€” Charleston, South Carolina

๐Ÿ“ž Contact the Study Coordinator

Phone: (843) 792-9115

Email: lenchd@musc.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—