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NCT Number: NCT07536022

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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location status: Recruiting

Location contact

Daniel Lench, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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.

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

    Time frame: 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

Secondary outcomes

  1. Change in Spatiotemporal Gait Parameters

    Time frame: Baseline, Week 4, Week 8, and 1-month follow-up

    Change in fear of falling measured using the FES-I questionnaire. Total score range: 16-64, with higher scores indicating greater concern about falling.

Other outcomes

  1. Target Engagement Measured by Resting-State Functional Connectivity MRI

    Time frame: Baseline and Week 8

    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.

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

    Time frame: Baseline, Week 4, and Week 8

    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).

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

    Time frame: Baseline, Week 4, Week 8, and 1-month follow-up

    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.

  4. Change in Non-Motor Symptoms Assessed by the Movement Disorder Society Non-Motor Symptoms Scale (MDS-NMS)

    Time frame: Baseline, Week 4, Week 8, and 1-month follow-up

    Change in non-motor symptom burden measured using the MDS-NMS. Higher scores indicate greater non-motor symptom severity

  5. Change in Cognitive Function Assessed by Neuropsychological Testing

    Time frame: Baseline, Week 4, and Week 8

    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.

  6. Change in Anxiety Symptoms Assessed by the Hamilton Anxiety Rating Scale (HAM-A)

    Time frame: Baseline, Week 4, and Week 8

    Change in anxiety severity measured by the HAM-A. Score range: 0-56, with higher scores indicating greater anxiety severity.

  7. Change in Depressive Symptoms Assessed by the Hamilton Depression Rating Scale (HAM-D)

    Time frame: Baseline, Week 4, and Week 8

    Change in depressive symptom severity measured by the HAM-D. Higher scores indicate greater depressive symptom severity.

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel Lench, PhD

CONTACT

[email protected]

+843-792-9115

Emily Laramie, HBSc

CONTACT

[email protected]

+843-792-3873

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 17, 2026
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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