Post-stroke Pain taVNS

Medical University of South Carolina (MUSC)

Status: Completed

Conditions: Stroke; Pain

Treatments: Device: Sham Auricular Stimulation; Device: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)

Study type: Interventional

Funder types: Other

Identifiers

NCT06456385

Pro00137146

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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15 participants in 2 patient groups

Auricular Neurostimulation (Active)

Active Comparator group

Description:

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

Treatment:

Device: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)

Auricular Neurostimulation (Sham)

Sham Comparator group

Description:

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

Treatment:

Device: Sham Auricular Stimulation