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At-home taVNS for Neurorehabilitation in Parkinson's Disease

NCT07536022 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2026-04-17

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

transcutaneous auricular nerve stimulation

frequency of 25 Hz, pulse width of 500 µs, duty cycle of 60 seconds ON, 30 seconds OFF, for a duration of 1 hour at an intensity of 200% of individualized perceptual threshold.

Sponsors & Collaborators

  • Medical University of South Carolina

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2027-04-30
Completion
2027-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07536022 on ClinicalTrials.gov