Clinical trial NCT06456385: Post-stroke Pain taVNS
Official title: Investigate the Anti-pain Effect of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) in Patients With Chronic Post-stroke Upper Extremity Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Pain
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2024-06-13
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Thermal Pain Threshold
timeFrame: Change from baseline pain threshold immediately post-taVNS
Secondary outcomes:
measure: Subjective Pain Ratings
timeFrame: Change from baseline subjective pain rating immediately post-taVNS
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina Institute of Psychiatry
state: South Carolina
Study officials:
References: