StrokeNCT06616831

At-Home taVNS - Stroke Rehab

A study testing Remote Transcutaneous Auricular Vagal Nerve Stimulation Paired with Task-Specific Training in people with Stroke and Stroke, Ischemic, run by Medical University of South Carolina at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Early evidence suggests the benefits of post-stroke motor rehabilitation may be enhanced by applying electrical stimulation to the ear. This study aims to test the new approach of pairing ear stimulation with motor rehabilitation in the home setting in stroke survivors with upper limb motor function deficits. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Stroke, Stroke, Ischemic, Stroke Hemorrhagic
What is being tested?: Remote Transcutaneous Auricular Vagal Nerve Stimulation Paired with Task-Specific Training
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 5 participants
Where: 1 siteUnited States
Study dates: 28 Oct 2024to 26 Mar 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

18-80 years old with an ischemic or hemorrhagic stroke that occurred ≥6 months prior;
Ability to give consent;
Unilateral limb (left or right) weakness with Fugl Meyer-Upper Extremity Scale score of 19-53/60 points which indicates adequate arm/hand use for rehabilitation tasks;
active wrist flexion/extension ≥10° with active abduction/extension of thumb and at least 1 digit ≥10° to further assure ability to participate in rehabilitation tasks;
Passive range of motion in affected shoulder, elbow and wrist within 20 degrees of normal values.

Who cannot join

Other concomitant neurological disorders affecting upper extremity motor function;
Presence of Dysphagia or aspiration difficulties;
Prior injury to vagus nerve;
Pregnancy;
Documented history of dementia before or after stroke;
Documented history of uncontrolled depression or psychiatric disorder either before or after stroke which could affect their ability to participate in the experiment;
Uncontrolled hypertension;
Botox injections within 4 weeks of the first day of rehabilitation therapy.

Trial locations and contacts

1 site in 1 country.

United States1 site

Medical University of South Carolina
Charleston, South Carolina, 29403

Other trials in United States

About this study

Official title: Development of At-Home Transcutaneous Auricular Vagus Nerve Stimulation for Post-Stroke Rehabilitation

Read the detailed description

This study seeks to advance prior research conducted here at MUSC exploring the use of transcutaneous auricular vagus nerve stimulation (taVNS) paired with motor rehabilitation to improve motor function post-stroke. Early evidence from a recently completed NIH-funded, clinical trial suggests that our new approach of delivering electrical stimulation to the ear at the same time as motor rehabilitation double the clinical benefits of motor rehabilitation. These benefits are due in part to a facilitation of neuroplasticity caused by activating the auricular branch of the vagus nerve.

This project takes this approach one step further, moving it into the home in combination with telerehabilitation in order to make this technology more accessible to individuals in rural and remote areas. In order to accomplish this, investigators will a) conduct lab-based testing and validation of the stimulation triggering sensors for at-home use, and b) determine the safety, feasibility, and acceptability of at-home taVNS in five stroke survivors with unilateral upper limb motor deficits.

Investigators hypothesize that our lab-based validation will facilitate an optimized home intervention. Furthermore, investigators hypothesize taVNS will be safe and feasible to self-administer in the at-home setting. Lastly, investigation will help elucidate any challenges that may occur as investigators begin to expand this technology into future larger trials

Conditions: Stroke, Stroke, Ischemic, Stroke Hemorrhagic
Being tested: Remote Transcutaneous Auricular Vagal Nerve Stimulation Paired with Task-Specific Training
Medical subject headings: Stroke, Ischemic Stroke, Hemorrhagic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Remote Transcutaneous Auricular Vagal Nerve Stimulation Paired with Task-Specific TrainingDevice
Each participant will complete 2 weeks, 3 times per week, task-specific training paired with transcutaneous auricular vagal nerve stimulation.

Study groups in NCT06616831
Study group	Role	What they receive
Remote Transcutaneous Auricular Vagal Nerve Stimulation Paired with Task Specific Training	Experimental	Task-specific training (TST) paired with EMG activated Transcutaneous Auricular Vagal Nerve Stimulation (taVNS) three times a week for two weeks in an At-Home setting. Receives: Device: Remote Transcutaneous Auricular Vagal Nerve Stimulation Paired with Task-Specific Training

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Dropped Out
Dropout rates will be assessed over the course of the study.
Measured: 2 weeks
Adverse Events
Any side effects or adverse events will be assessed.
Measured: 2 weeks
Mean Participant Compliance With Prescribed At-Home Sessions
Compliance defined as the percentage of prescribed at-home transcutaneous auricular vagus nerve stimulation (taVNS) paired with task-specific training sessions completed by each participant during the 2-week intervention (6 sessions per participant).
Measured: 2 weeks
Feasibility of Independent Completion of At-Home Study Procedures
Feasibility was assessed during each remotely supervised at-home session using a 3-point assistance scale evaluating the participant's ability to independently complete study procedures at home. Ratings were assigned as follows: 1 = no assistance required, 2 = minimal assistance required, and 3 = maximum assistance required. Lower scores indicate greater participant independence and greater feasibility of at-home administration.
Measured: 2 weeks

Secondary outcomes (3)

Percentage of Supervised At-Home Sessions Meeting Prespecified Feasibility Criteria
Feasibility was defined as the proportion of supervised at-home sessions that met both prespecified criteria: (1) completion of greater than 80% of prescribed motor rehabilitation activities and (2) receipt of at least 45 minutes of transcutaneous auricular vagus nerve stimulation during the session.
Measured: 2 weeks
Motor Function- Fugl-Meyer Assessment
Motor function will be assessed in-person at baseline and at the end of the two-week intervention using the Fugl-Meyer Assessment (FMA).
Measured: 2 weeks
Motor Function- Wolf Motor Function
Motor function will be assessed in-person at baseline and at the end of the two-week intervention using the Wolf Motor Function Test.
Measured: 2-weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Oct 202426 Mar 2025

First posted27 Sep 2024
Study start28 Oct 2024
Primary completion26 Mar 2025
Study completion26 Mar 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for StrokeStudies 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: 5 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06616831
Sponsor's protocol ID: Pro00137256
Status last verified: Jul 2026
First submitted: 12 Aug 2024
Last updated: 13 Aug 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Badran BW, Peng X, Baker-Vogel B, Hutchison S, Finetto P, Rishe K, Fortune A, Kitchens E, O'Leary GH, Short A, Finetto C, Woodbury ML, Kautz S. Motor Activated Auricular Vagus Nerve Stimulation as a Potential Neuromodulation Approach for Post-Stroke Motor Rehabilitation: A Pilot Study. Neurorehabil Neural Repair. 2023 Jun;37(6):374-383. doi: 10.1177/15459683231173357. Epub 2023 May 20.
PubMed 37209010

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Development of At-Home Transcutaneous Auricular Vagus Nerve Stimulation for Post-Stroke Rehabilitation
ClinicalTrials.gov ID: NCT06616831
Acronym / sponsor ID: Pro00137256
Conditions: Stroke, Stroke, Ischemic, Stroke Hemorrhagic
Study type: Interventional
Recruitment status: Completed
Enrolment: 5 participants (actual)
Lead sponsor: Medical University of South CarolinaUniversity, hospital or other
Collaborators: National Institute of General Medical Sciences (NIGMS)
Study start: 28 Oct 2024 (actual)
Primary completion: 26 Mar 2025 (actual)
Study completion: 26 Mar 2025 (actual)
First posted: 27 Sep 2024 (actual)
Results: Posted 13 Aug 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Remote Transcutaneous Auricular Vagal Nerve Stimulation Paired with Task Specific Training	Experimental	Device: Remote Transcutaneous Auricular Vagal Nerve Stimulation Paired with Task-Specific TrainingTask-specific training (TST) paired with EMG activated Transcutaneous Auricular Vagal Nerve Stimulation (taVNS) three times a week for two weeks in an At-Home setting.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

18-80 years old with an ischemic or hemorrhagic stroke that occurred ≥6 months prior;
Ability to give consent;
Unilateral limb (left or right) weakness with Fugl Meyer-Upper Extremity Scale score of 19-53/60 points which indicates adequate arm/hand use for rehabilitation tasks;
active wrist flexion/extension ≥10° with active abduction/extension of thumb and at least 1 digit ≥10° to further assure ability to participate in rehabilitation tasks;
Passive range of motion in affected shoulder, elbow and wrist within 20 degrees of normal values.

Key exclusion criteria (8 listed)

Other concomitant neurological disorders affecting upper extremity motor function;
Presence of Dysphagia or aspiration difficulties;
Prior injury to vagus nerve;
Pregnancy;
Documented history of dementia before or after stroke;

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
Remote Transcutaneous Auricular Vagal Nerve Stimulation Paired with Task-Specific TrainingEach participant will complete 2 weeks, 3 times per week, task-specific training paired with transcutaneous auricular vagal nerve stimulation.	Device	Remote Transcutaneous Auricular Vagal Nerve Stimulation Paired with Task Specific Training

Primary outcome

Number of Participants Dropped Out
Time frame: 2 weeks
Dropout rates will be assessed over the course of the study.
Adverse Events
Time frame: 2 weeks
Any side effects or adverse events will be assessed.
Mean Participant Compliance With Prescribed At-Home Sessions
Time frame: 2 weeks
Compliance defined as the percentage of prescribed at-home transcutaneous auricular vagus nerve stimulation (taVNS) paired with task-specific training sessions completed by each participant during the 2-week intervention (6 sessions per participant).
Feasibility of Independent Completion of At-Home Study Procedures
Time frame: 2 weeks
Feasibility was assessed during each remotely supervised at-home session using a 3-point assistance scale evaluating the participant's ability to independently complete study procedures at home. Ratings were assigned as follows: 1 = no assistance required, 2 = minimal assistance required, and 3 = maximum assistance required. Lower scores indicate greater participant independence and greater feasibility of at-home administration.

3 secondary outcomes

Percentage of Supervised At-Home Sessions Meeting Prespecified Feasibility Criteria
Time frame: 2 weeks
Motor Function- Fugl-Meyer Assessment
Time frame: 2 weeks
Motor Function- Wolf Motor Function
Time frame: 2-weeks

Results and safety

Results posted to the registry on 13 Aug 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Remote Transcutaneous Auricular Vagal Nerve Stimulation Paired With Task Specific Training	5	5

Primary outcome: Number of Participants Dropped Out

Time frame: 2 weeks. Count of participants. Unit: Participants

Measure	Remote Transcutaneous Auricular Vagal Nerve Stimulation Paired With Task Specific Training n = 5
Value	0

Primary outcome: Adverse Events

Time frame: 2 weeks. Number. Unit: Adverse Events or side effects noted

Measure	Remote Transcutaneous Auricular Vagal Nerve Stimulation Paired With Task Specific Training n = 5
Value	0

Primary outcome: Mean Participant Compliance With Prescribed At-Home Sessions

Time frame: 2 weeks. Mean (Standard Deviation). Unit: percentage

Measure	Remote Transcutaneous Auricular Vagal Nerve Stimulation Paired With Task Specific Training n = 5
Value	100 (0)

Population analysed: At least 45 minutes of stimulation+therapy was completed per participant during virtual visits with study members and compliance was confirmed.

Primary outcome: Feasibility of Independent Completion of At-Home Study Procedures

Time frame: 2 weeks. Mean (Standard Deviation). Unit: scores on a scale

Measure	Remote Transcutaneous Auricular Vagal Nerve Stimulation Paired With Task Specific Training n = 5
Virtual Visit 1	1.6 (0.89)
Virtual Visit 2	1.2 (0.45)
Virtual Visit 3	0.45 (1.2)
Virtual Visit 4	1 (0)
Virtual Visit 5	1 (0)
Virtual Visit 6	1 (0)

Population analysed: Participants were evaluated during each supervised at-home session using a 3-point assistance scale. Scores were assigned as follows: 1 = no assistance required, 2 = minimal assistance required, and 3 = maximum assistance required to complete study procedures. Lower scores indicate greater participant independence and feasibility of at-home administration.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 2-weeks of study procedures.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Remote Transcutaneous Auricular Vagal Nerve Stimulation Paired With Task Specific Training	0 of 5 (0%)	0 of 5 (0%)	0 of 5

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 37209010Badran BW, Peng X, Baker-Vogel B, Hutchison S, Finetto P, Rishe K, Fortune A, Kitchens E, O'Leary GH, Short A, Finetto C, Woodbury ML, Kautz S. Motor Activated Auricular Vagus Nerve Stimulation as a Potential Neuromodulation Approach for Post-Stroke Motor Rehabilitation: A Pilot Study. Neurorehabil Neural Repair. 2023 Jun;37(6):374-383. doi: 10.1177/15459683231173357. Epub 2023 May 20.
Individual participant dataSharing planned: No

Related trials for Stroke

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Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Recruiting
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Not yet recruiting
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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. This study is not recruiting at the moment.

Bashar Badran, PhD principal investigator

Medical University of South Carolina

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 8 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: finished, as of the sponsor's last update on 13 Aug 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?

Yes. Results are posted in the registry (first posted 13 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Dropped Out (time frame: 2 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06616831, which also lists 1 linked publication.

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 13 Aug 2026.