Post-stroke Pain taVNS

Not Applicable

Recruiting

• Conditions: Stroke; Pain
• Interventions: Device: Sham Auricular Stimulation; Device: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)

• Registration Number: NCT06456385
• Lead Sponsor: Medical University of South Carolina

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.

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 Timeline

• Status Verified: 2024-06
• Study Start: 2024-06-04
• Study First Submitted: 2024-06-04
• Study First Submitted QC: 2024-06-07
• Last Update Submitted: 2024-06-07
• Study First Posted: 2024-06-13
• Last Update Posted: 2024-06-13
• Primary Completion: 2025-06-03
• Study Completion: 2025-06-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Auricular Neurostimulation (Sham)	Sham Auricular Stimulation	Participants will receive auricular stimulation of 15Hz on their earlobe.
Auricular Neurostimulation (Active)	Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)	Participants will receive auricular stimulation of both the 15Hz on cymba conchae and 100Hz on tragus.

Primary Outcome Measures

Name	Time	Method
Thermal Pain Threshold	Change from baseline pain threshold immediately post-taVNS	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 Outcome Measures

Name	Time	Method
Subjective Pain Ratings	Change from baseline subjective pain rating immediately post-taVNS	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).

Trial Locations

Locations (1)

Medical University of South Carolina Institute of Psychiatry; 🇺🇸 Charleston, South Carolina, United States