Could a daily ear-stimulation gadget ease Parkinson's at home?
NCT ID NCT07536022
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether a device that gently stimulates a nerve in the ear (taVNS) can help with Parkinson's symptoms like walking and balance problems. Sixteen adults with Parkinson's will use the device at home for one hour daily over eight weeks. Researchers will check if it's practical, safe, and whether it leads to any improvements in movement, thinking, or mood.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- transcutaneous auricular vagus nerve stimulation (taVNS) device
- What this could lead to
- If it works, this could point toward a convenient, drug-free way to manage Parkinson's symptoms at home.
- What could go wrong
- This is a very small, early feasibility study with only 16 people, so results may not apply widely. The device may cause discomfort or fail to improve symptoms.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 16 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Medical University of South Carolina
RECRUITINGCharleston, South Carolina, 29425, United States
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- Can an inhaled levodopa ease Parkinson's OFF episodes? a study asks patients.