At-home taVNS for Neurorehabilitation in Parkinson's Disease

NCT07536022 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: Pro00149153
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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:

• 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

Parkinson's Disease

Keywords

Parkinson's Disease; parkinsons; parkinson's; taVNS; transcutaneous vagus nerve stimulation; non-invasive brain stimulation; transcutaneous auricular vagus nerve stimulation; gait; motor symptoms

Outcome Measures

Primary Outcomes (2)

• Adherence to At-Home Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)

  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.

  Baseline to end of 8-week at-home taVNS intervention

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

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

  Baseline, Week 4, and Week 8

Secondary Outcomes (1)

• Change in Spatiotemporal Gait Parameters

  Baseline, Week 4, Week 8, and 1-month follow-up

Other Outcomes (7)

• Target Engagement Measured by Resting-State Functional Connectivity MRI

  Baseline and Week 8

• Change in Global Severity and Improvement Assessed by the Clinical Global Impression Scales (CGI-S and CGI-I)

  Baseline, Week 4, and Week 8

• Change in Freezing of Gait Assessed by the New Freezing of Gait Questionnaire (nFOG-Q)

  Baseline, Week 4, Week 8, and 1-month follow-up

Study Arms (1)

taVNS Stimulation

EXPERIMENTAL

one in-person taVNS session followed by 8 weeks of at-home taVNS sessions

Device: transcutaneous auricular nerve stimulation

Interventions

transcutaneous auricular nerve stimulation DEVICE

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.

taVNS Stimulation

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

Daniel Lench, PhD

CONTACT

+843-792-9115; lenchd@musc.edu

Emily Laramie, HBSc

CONTACT

+843-792-3873; laramie@musc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: April 17, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

US (1)