At-home taVNS for Neurorehabilitation in Parkinson's Disease

Developing At-home taVNS for Neurorehabilitation in Parkinson's Disease

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Parkinson's Disease
• Intervention / Treatment: Device: transcutaneous auricular nerve stimulation

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniel Lench, PhD; Phone Number: +843-792-9115; Email: lenchd@musc.edu
• Study Contact Backup: Name: Emily Laramie, HBSc; Phone Number: +843-792-3873; Email: laramie@musc.edu

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
      • Principal Investigator: Daniel Lench, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: taVNS Stimulation; one in-person taVNS session followed by 8 weeks of at-home taVNS sessions	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Spatiotemporal Gait Parameters	Change in fear of falling measured using the FES-I questionnaire. Total score range: 16-64, with higher scores indicating greater concern about falling.	Baseline, Week 4, Week 8, and 1-month follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target Engagement Measured by Resting-State Functional Connectivity MRI	Change in resting-state functional connectivity between locomotor, cognitive, and limbic networks measured using resting-state functional MRI. Connectivity metrics will be derived from seed-based analyses to assess changes in inter-network and intra-network connectivity.	Baseline and Week 8
Change in Global Severity and Improvement Assessed by the Clinical Global Impression Scales (CGI-S and CGI-I)	Change in clinician-rated global illness severity (CGI-S) and global improvement (CGI-I). CGI-S score range: 1 (Normal) to 7 (Among the most extremely ill). CGI-I score range: 1 (Very much improved) to 7 (Very much worse).	Baseline, Week 4, and Week 8
Change in Freezing of Gait Assessed by the New Freezing of Gait Questionnaire (nFOG-Q)	Change in freezing of gait severity measured by the nFOG-Q. Total score range: 0-28, with higher scores indicating more severe freezing of gait.	Baseline, Week 4, Week 8, and 1-month follow-up
Change in Non-Motor Symptoms Assessed by the Movement Disorder Society Non-Motor Symptoms Scale (MDS-NMS)	Change in non-motor symptom burden measured using the MDS-NMS. Higher scores indicate greater non-motor symptom severity	Baseline, Week 4, Week 8, and 1-month follow-up
Change in Cognitive Function Assessed by Neuropsychological Testing	Change in cognitive performance assessed using standardized neuropsychological tests including the Delis-Kaplan Executive Function System (verbal fluency and switching), Stroop Color-Word Interference Test, Digit Span, and FAS Verbal Fluency Test. Higher test scores indicate better cognitive performance.	Baseline, Week 4, and Week 8
Change in Anxiety Symptoms Assessed by the Hamilton Anxiety Rating Scale (HAM-A)	Change in anxiety severity measured by the HAM-A. Score range: 0-56, with higher scores indicating greater anxiety severity.	Baseline, Week 4, and Week 8
Change in Depressive Symptoms Assessed by the Hamilton Depression Rating Scale (HAM-D)	Change in depressive symptom severity measured by the HAM-D. Higher scores indicate greater depressive symptom severity.	Baseline, Week 4, and Week 8

Collaborators and Investigators

• Sponsor: Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: April 2, 2026
• First Submitted That Met QC Criteria: April 10, 2026
• First Posted (Actual): April 17, 2026

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: gait; Parkinson's Disease; transcutaneous auricular vagus nerve stimulation; non-invasive brain stimulation; motor symptoms; taVNS; parkinsons; parkinson's; transcutaneous vagus nerve stimulation
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease
• Other Study ID Numbers: Pro00149153

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Information about participants (including their identifiable private information and/or any identifiable biospecimens) may have all of their identifiers removed and used for future research studies or distributed to other researchers for future research without additional informed consent from participants or their legally authorized representative. This is documented in the informed consent form.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes