At-home taVNS for Neurorehabilitation in Parkinson's Disease

April 10, 2026 updated by: Medical University of South Carolina

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Daniel Lench, PhD
  • Phone Number: +843-792-9115
  • Email: lenchd@musc.edu

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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)
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
Baseline, Week 4, and Week 8

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, Week 4, Week 8, and 1-month follow-up

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline and Week 8
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).
Baseline, Week 4, and Week 8
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.
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)
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
Baseline, Week 4, Week 8, and 1-month follow-up
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.
Baseline, Week 4, and Week 8
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.
Baseline, Week 4, and Week 8
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.
Baseline, Week 4, and Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University of South Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 2, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 17, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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