Parkinson's DiseaseNCT07536022
At-home taVNS for Neurorehabilitation in Parkinson's Disease
A study testing transcutaneous auricular nerve stimulation in people with Parkinson's Disease, run by Medical University of South Carolina at 1 site in United States.
Trial 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: 1. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- transcutaneous auricular nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Daniel Lench, PhD
About this study
Official title: 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:
Read more
- 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?
- 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.
- Conditions
- Parkinson's Disease
- Being tested
- transcutaneous auricular nerve stimulation
- Keywords
- Parkinson's Disease, parkinsons, parkinson's, taVNS, transcutaneous vagus nerve stimulation, non-invasive brain stimulation, transcutaneous auricular vagus nerve stimulation, gait, motor symptoms
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous auricular nerve stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| taVNS Stimulation | Experimental | one in-person taVNS session followed by 8 weeks of at-home taVNS sessions Receives: Device: transcutaneous auricular nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Baseline, Week 4, and Week 8
Secondary outcomes (1)
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.
Measured: Baseline, Week 4, Week 8, and 1-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start1 Jun 2026
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07536022
- Sponsor's protocol ID
- Pro00149153
- Status last verified
- Jun 2026
- First submitted
- 2 Apr 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing At-home taVNS for Neurorehabilitation in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07536022
- Acronym / sponsor ID
- Pro00149153
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 17 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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?
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| taVNS Stimulation | Experimental | Device: transcutaneous auricular nerve stimulationone in-person taVNS session followed by 8 weeks of at-home taVNS sessions |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcutaneous auricular nerve stimulationfrequency 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. | Device | taVNS Stimulation |
Primary outcome
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.
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
1 secondary outcome
Change in Spatiotemporal Gait Parameters
Time frame: Baseline, Week 4, Week 8, and 1-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcutaneous auricular nerve stimulation in people with Parkinson's Disease, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel Lench, PhD (+843-792-9115, lenchd@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to At-Home Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) (time frame: Baseline to end of 8-week at-home taVNS intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.