Post-stroke Pain taVNS

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06456385
• Other study ID #: Pro00137146
• Status: Recruiting
• Phase: N/A
• Start date: June 4, 2024
• Est. completion date: June 3, 2025

Study information

• Verified date: June 2024
• Source: Medical University of South Carolina
• Contact: Xiaolong Peng, PhD
• Phone: 843-792-9502
• Email: pengxi[@]musc.edu
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 3, 2025
• Est. primary completion date: June 3, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain
• Stroke

Intervention

Device:
• 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.
• Sham Auricular Stimulation
The sham auricular stimulation administers electrical stimulation at the ear lobe which has less auricular branch of the vagus nerve.

Locations

Country	Name	City	State
United States	Medical University of South Carolina Institute of Psychiatry	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from baseline pain threshold immediately post-taVNS
Secondary	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).	Change from baseline subjective pain rating immediately post-taVNS