At-home taVNS for Parkinson's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study explores the feasibility and preliminary efficacy of delivering taVNS to adults with idiopathic Parkinson's disease at home. Participants will have baseline MRI and complete motor, cognitive, and neuropsychiatric assessments to measure changes with taVNS. The trial looks at how often participants can complete the stimulation protocol, any side effects, and user experience, as well as changes in neural networks at rest.

Why it matters

Who can join: the full rules

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

Where it's running

• Medical University of South Carolina
  Charleston, South Carolina, United States Recruiting

Study contacts

• Study coordinator: Daniel Lench, PhD
• Email: lenchd@musc.edu
• Phone: +843-792-9115

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.