StrokeNCT06456385
Post-stroke Pain taVNS
A study testing Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) in people with Stroke and Pain, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The purpose of this study is to explore whether a non-invasive form of ear stimulation called transcutaneous auricular vagus nerve stimulation (taVNS) can change the way participants perceive pain. Investigators will recruit up to 20 participants with chronic post-stroke upper extremity pain. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- What is being tested?
- Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 2024to 26 Sep 2024
- 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
- Age 18-80
- Have the capacity and ability to provide one's own consent in English and sign the informed consent document.
- Ischemic or hemorrhagic stroke that occurred at least 6 months prior
- Unilateral stroke lesions in the left hemisphere
- Right upper extremity pain
Who cannot join
- Primary intracerebral hematoma or subarachnoid hemorrhage
- Documented history of dementia
- Documented history of uncontrolled depression or psychiatric disorder
- Uncontrolled hypertension despite treatment, specifically SBP (Systolic Blood Pressure) / DBP (Diastolic Blood Pressure) >=180/100mmHg
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina Institute of Psychiatry
Charleston, South Carolina, 29425
About this study
Official title: Investigate the Anti-pain Effect of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) in Patients With Chronic Post-stroke Upper Extremity Pain
The purpose of this study is to explore whether a non-invasive form of ear stimulation called transcutaneous auricular vagus nerve stimulation (taVNS) can change the way participants perceive pain. Investigators will recruit up to 20 participants with chronic post-stroke upper extremity pain. The goal is to determine if there is a pain reduction after ear stimulation.
Read the detailed description
In this study, investigators main goal is to establish transcutaneous auricular vagus nerve stimulation (taVNS) as an effective non-invasive neuromodulation method for analgesia of post-stroke upper extremity pain. Participants are required to have an ischemic or hemorrhagic stroke that occurred at least 6 months prior and are currently suffering upper extremity pain. Each participant will undergo an in-person visit. Participants will first finish the pain questionnaires and have quantitative sensory testing (QST) conducted to determine baseline pain thresholds. Participants will then receive 30 minutes of taVNS (either active or sham). Upon the completion of the stimulation intervention, participants will then be tested for another QST and pain questionnaires.
Aim 1: Test the safety and feasibility of taVNS in participants with chronic post-stroke upper extremity pain.
Over the last 8 years, investigators have demonstrated that taVNS is safe and feasible in several different populations in our previous studies. Specifically, investigators have demonstrated that taVNS is well tolerated and safe for participants with chronic stroke in our previous clinical trial. In this study, investigators will further verify the safety and feasibility of taVNS in the population with chronic post-stroke upper extremity pain.
Aim 2: Investigate whether taVNS can modulate pain in this population compared to sham.
In this single-visit, double-blinded, sham-controlled pilot trial, investigators will compare changes in post-stroke upper extremity pain scores and pain threshold derived from QST before and after a 30-minute taVNS intervention, as well as between active and sham taVNS. The findings will help investigators understand whether taVNS can modulate pain in this population.
- Being tested
- Transcutaneous Auricular Vagus Nerve Stimulation (taVNS), Sham Auricular Stimulation
- Medical subject headings
- Stroke, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)Device
The intervention applied is called transcutaneous auricular vagus nerve stimulation (taVNS) which administers electrical stimulation at the ear which targets the auricular branch of the vagus nerve.
Sham Auricular StimulationDevice
The sham auricular stimulation administers electrical stimulation at the ear lobe which has less auricular branch of the vagus nerve.
| Study group | Role | What they receive |
|---|---|---|
| Auricular Neurostimulation (Active) | Active comparator | Participants will receive auricular stimulation of both the 15Hz on cymba conchae and 100Hz on tragus. Receives: Device: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) |
| Auricular Neurostimulation (Sham) | Sham comparator | Participants will receive auricular stimulation of 15Hz on their earlobe. Receives: Device: Sham Auricular Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thermal Pain Threshold
Using a quantitative sensory testing paradigm, the investigators will systematically determine information on thermal pain tolerance thresholds (degrees celsius) using a 30 × 30 mm thermode attached to the left forearm of participants.
Measured: assessed during and immediately after the single 30-minute taVNS session, Post 30-minute taVNS reported
Secondary outcomes (1)
Subjective Pain Ratings
Participants will rate their post-stroke upper extremity pain intensity before and after the taVNS using a standard numeric pain rating scale (from minimum 0 to maximum 10, higher scores mean more pain).
Measured: assessed during and immediately after the single 30-minute taVNS session, Post 30-minute taVNS reported
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start4 Jun 2024
- Primary completion26 Sep 2024
- Study completion26 Sep 2024
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
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
- NCT06456385
- Sponsor's protocol ID
- Pro00137146
- Status last verified
- Aug 2025
- First submitted
- 4 Jun 2024
- Last updated
- 22 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Peng X, Cox SS, Baker-Vogel B, Omonije F, Tucker K, Huttig B, Sutton F, Cash N, Wood M, Kautz SA, Badran BW, Borckardt JJ. Transcutaneous Auricular Neurostimulation Modulates Pain Perception in Survivors of Stroke With Chronic Upper-Extremity Pain: A Randomized, Sham-Controlled Pilot Study. Neuromodulation. 2026 Jun;29(4):607-615. doi: 10.1016/j.neurom.2025.12.005. Epub 2026 Jan 16.
PubMed 41543462
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigate the Anti-pain Effect of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) in Patients With Chronic Post-stroke Upper Extremity Pain
- ClinicalTrials.gov ID
- NCT06456385
- Acronym / sponsor ID
- Pro00137146
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 4 Jun 2024 (actual)
- Primary completion
- 26 Sep 2024 (actual)
- Study completion
- 26 Sep 2024 (actual)
- First posted
- 13 Jun 2024 (actual)
- Results
- Posted 22 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to explore whether a non-invasive form of ear stimulation called transcutaneous auricular vagus nerve stimulation (taVNS) can change the way participants perceive pain. Investigators will recruit up to 20 participants with chronic post-stroke upper extremity pain. The goal is to determine if there is a pain reduction after ear stimulation.
Detailed description
In this study, investigators main goal is to establish transcutaneous auricular vagus nerve stimulation (taVNS) as an effective non-invasive neuromodulation method for analgesia of post-stroke upper extremity pain. Participants are required to have an ischemic or hemorrhagic stroke that occurred at least 6 months prior and are currently suffering upper extremity pain. Each participant will undergo an in-person visit. Participants will first finish the pain questionnaires and have quantitative sensory testing (QST) conducted to determine baseline pain thresholds. Participants will then receive 30 minutes of taVNS (either active or sham). Upon the completion of the stimulation intervention, participants will then be tested for another QST and pain questionnaires.
Aim 1: Test the safety and feasibility of taVNS in participants with chronic post-stroke upper extremity pain.
Over the last 8 years, investigators have demonstrated that taVNS is safe and feasible in several different populations in our previous studies. Specifically, investigators have demonstrated that taVNS is well tolerated and safe for participants with chronic stroke in our previous clinical trial. In this study, investigators will further verify the safety and feasibility of taVNS in the population with chronic post-stroke upper extremity pain.
Aim 2: Investigate whether taVNS can modulate pain in this population compared to sham.
In this single-visit, double-blinded, sham-controlled pilot trial, investigators will compare changes in post-stroke upper extremity pain scores and pain threshold derived from QST before and after a 30-minute taVNS intervention, as well as between active and sham taVNS. The findings will help investigators understand whether taVNS can modulate pain in this population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Auricular Neurostimulation (Active) | Active comparator | Device: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)Participants will receive auricular stimulation of both the 15Hz on cymba conchae and 100Hz on tragus. |
| Auricular Neurostimulation (Sham) | Sham comparator | Device: Sham Auricular StimulationParticipants will receive auricular stimulation of 15Hz on their earlobe. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-80
- Have the capacity and ability to provide one's own consent in English and sign the informed consent document.
- Ischemic or hemorrhagic stroke that occurred at least 6 months prior
- Unilateral stroke lesions in the left hemisphere
- Right upper extremity pain
Key exclusion criteria (5 listed)
- Primary intracerebral hematoma or subarachnoid hemorrhage
- Documented history of dementia
- Documented history of uncontrolled depression or psychiatric disorder
- Uncontrolled hypertension despite treatment, specifically SBP (Systolic Blood Pressure) / DBP (Diastolic Blood Pressure) >=180/100mmHg
- Pregnancy
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 Vagus Nerve Stimulation (taVNS)The intervention applied is called transcutaneous auricular vagus nerve stimulation (taVNS) which administers electrical stimulation at the ear which targets the auricular branch of the vagus nerve. | Device | Auricular Neurostimulation (Active) |
| Sham Auricular StimulationThe sham auricular stimulation administers electrical stimulation at the ear lobe which has less auricular branch of the vagus nerve. | Device | Auricular Neurostimulation (Sham) |
Primary outcome
Thermal Pain Threshold
Time frame: assessed during and immediately after the single 30-minute taVNS session, Post 30-minute taVNS reported
Using a quantitative sensory testing paradigm, the investigators will systematically determine information on thermal pain tolerance thresholds (degrees celsius) using a 30 × 30 mm thermode attached to the left forearm of participants.
1 secondary outcome
Subjective Pain Ratings
Time frame: assessed during and immediately after the single 30-minute taVNS session, Post 30-minute taVNS reported
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41543462Peng X, Cox SS, Baker-Vogel B, Omonije F, Tucker K, Huttig B, Sutton F, Cash N, Wood M, Kautz SA, Badran BW, Borckardt JJ. Transcutaneous Auricular Neurostimulation Modulates Pain Perception in Survivors of Stroke With Chronic Upper-Extremity Pain: A Randomized, Sham-Controlled Pilot Study. Neuromodulation. 2026 Jun;29(4):607-615. doi: 10.1016/j.neurom.2025.12.005. Epub 2026 Jan 16.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Vagus Nerve Stimulation (taVNS) in people with Stroke and Pain, 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 5 inclusion and 5 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 22 Aug 2025. 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. Some participants in this study may receive a placebo. 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 22 Aug 2025). 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?
Thermal Pain Threshold (time frame: assessed during and immediately after the single 30-minute taVNS session, Post 30-minute taVNS reported). 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 NCT06456385, 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 22 Aug 2025.