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At-home taVNS for Parkinson's Disease

This study is testing a device called transcutaneous auricular nerve stimulation (taVNS) for people with Parkinson's Disease. Researchers want to see if using taVNS at home can help with Parkinson's symptoms, especially issues with walking, balance, and gait. They will also look at how easy it is for people to use the device at home and if there are any side effects. The study aims to enroll 16 participants between 40 and 85 years old who have been diagnosed with Parkinson's Disease and have specific walking or balance difficulties. Success will be measured by how well participants stick to the taVNS treatment and by changes in their Parkinson's motor symptoms over 8 weeks.

Study design
This is an interventional study planning to enroll 16 participants. The study will investigate the effects of transcutaneous auricular nerve stimulation (taVNS).
What's involved
You would use the taVNS device at home for 1 hour per day. Your Parkinson's motor symptoms will be assessed at the start, at week 4, and at week 8.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints are measured up to the end of the 8-week at-home taVNS intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07536022

At-home taVNS for Neurorehabilitation in Parkinson's Disease

Recruiting
NAAges 40–85InterventionalTreatment
Medical University of South Carolina
~16 participants
Updated 2026-06-15 on ClinicalTrials.gov
What's tested:transcutaneous auricular nerve stimulation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Adherence to At-Home Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)
Measured over Baseline to end of 8-week at-home taVNS intervention
+1 more outcome measured

Conditions

Parkinson's Disease

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NCT07536022

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Medical University of South Carolina

    Charleston, South Carolinano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Daniel Lench, PhD
[email protected]
+843-792-9115
Email the study team

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Eligibility criteria

Inclusion

Issues with walking, balance, and gait as determined by a movement disorders neurologist (a score of equal to or greater than 1 on MDS-UPDRS items 2.12 (walking and balance), and 3.10 (gait))
Diagnosis of idiopathic Parkinson's Disease based on UK Brain Bank diagnostic criteria
Hoehn and Yahr Stage 2-4 as determined by a movement disorders neurologist
Stable on dopaminergic medications over the past 30 days prior to enrollment in the study

Exclusion

A history of taVNS in the last 6 months
A history of brain surgery, traumatic brain injury or stroke
Diagnosis of a nervous system disorder besides PD, alcohol or substance use disorder, or unstable cardiovascular conditions
History of myocardial infarction or arrhythmia, bradycardia
A history of other significant gait impairment unrelated to PD (e.g. orthopedic deformities)
Inability to complete gait/ motor assessments (without assistance or assistance devices)
Ear trauma, facial pain, anatomical abnormalities or other barriers preventing earpiece fit
Failure to meet all criteria on a standardized MRI/taVNS safety screening: This includes, but is not limited to, the presence of claustrophobia, implanted electronic devices that are not 3T MRI compatible (e.g., pacemakers), metallic objects or fragments (e.g., bullets), and non-removable hair clips or piercings.
Individuals with a diagnosis of cognitive impairment (MoCA \< 24) that would make them unable to understand and follow study instructions or to consent for themselves.
Pregnancy
Visual hallucinations or other psychotic symptoms, other than mild visual hallucinations secondary to PD medications, not requiring treatment, or well controlled on stable doses of quetiapine or pimavenserin.
Individuals with a history of seizure(s)
Inability to perform at-home taVNS procedures safely and properly (either alone or with the aid of a caregiver)
Uncorrected visual or hearing impairments that would impact performance on cognitive tests or ability to follow study procedures
Use of B-Blockers, dopamine blocking agent (other than quetiapine or pimavenserin in stable doses), antiarrhythmic medication, acetylcholine esterase inhibitor (study doctor will consider if on stable doses), midodrine, fludrocortisone, droxidopa, or anticholinergic drugs

What this trial measures

  • Adherence to At-Home Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)Baseline to end of 8-week at-home taVNS intervention

    Adherence defined as the percentage of prescribed daily taVNS sessions completed over the 8-week intervention period, measured using automated device usage logs from the Sparrow Link Hub and mobile application.

  • Change in Parkinson's Disease Motor Symptoms Assessed by the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS III)Baseline, Week 4, and Week 8

    Change in motor symptom severity measured using the MDS-UPDRS Part III. Total score range: 0-132, with higher scores indicating worse motor impairment