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Completed

NCT Number: NCT06456385

Post-stroke Pain taVNS

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina Institute of Psychiatry

Charleston, South Carolina, 29425, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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 Stimulation

Device

The sham auricular stimulation administers electrical stimulation at the ear lobe which has less auricular branch of the vagus nerve.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Subjective Pain Ratings

    Time frame: assessed during and immediately after the single 30-minute taVNS session, Post 30-minute taVNS reported

    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).

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Official study title

Investigate the Anti-pain Effect of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) in Patients With Chronic Post-stroke Upper Extremity Pain

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 13, 2024
Registry last updated
Aug 22, 2025

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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