Post-stroke Pain taVNS

NCT06456385 | Completed Results FDA Device

• 1 other identifier: Pro00137146
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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. The goal is to determine if there is a pain reduction after ear stimulation.

Conditions

Stroke; Pain

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (1)

• Subjective Pain Ratings

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

Study Arms (2)

Auricular Neurostimulation (Active)

ACTIVE COMPARATOR

Participants will receive auricular stimulation of both the 15Hz on cymba conchae and 100Hz on tragus.

Device: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)

Auricular Neurostimulation (Sham)

SHAM COMPARATOR

Participants will receive auricular stimulation of 15Hz on their earlobe.

Device: Sham Auricular Stimulation

Interventions

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.

Auricular Neurostimulation (Active)

Sham Auricular Stimulation DEVICE

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

Auricular Neurostimulation (Sham)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina Institute of Psychiatry

Charleston, South Carolina, 29425, United States

Location

Related Publications (1)

• 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 Jan 16:S1094-7159(25)01202-4. doi: 10.1016/j.neurom.2025.12.005. Online ahead of print.

  PMID: 41543462 DERIVED

MeSH Terms

Conditions

Stroke; Pain

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

This study was an early proof-of-concept pilot trial designed to establish safety and feasibility for tAN in individuals with chronic PSP. This study has a relatively small sample size, and future studies should be adequately powered to more clearly determine the clinical efficacy of tAN.

Results Point of Contact

• Title: Dr. Xiaolong Peng
• Organization: Medical University of South Carolina

pengxi@musc.edu

8437928642

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: June 13, 2024
• Study Start: June 4, 2024
• Primary Completion: September 26, 2024
• Study Completion: September 26, 2024
• Last Updated: August 22, 2025
• Results First Posted: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)