Stroke, Pain
Conditions
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.
Interventions
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.
DEVICESham Auricular Stimulation
The sham auricular stimulation administers electrical stimulation at the ear lobe which has less auricular branch of the vagus nerve.
Sponsors
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Thermal Pain Threshold | assessed during and immediately after the single 30-minute taVNS session, Post 30-minute taVNS reported | 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
| Measure | Time frame | Description |
|---|---|---|
| Subjective Pain Ratings | assessed during and immediately after the single 30-minute taVNS session, Post 30-minute taVNS reported | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Auricular Neurostimulation (Active) Participants will receive auricular stimulation of both the 15Hz on cymba conchae and 100Hz on tragus. | 7 |
| Auricular Neurostimulation (Sham) Participants will receive auricular stimulation of 15Hz on their earlobe. | 8 |
| Total | 15 |
Baseline characteristics
| Characteristic | Auricular Neurostimulation (Active) | Auricular Neurostimulation (Sham) | Total |
|---|---|---|---|
| Age, Continuous | 51.43 year STANDARD_DEVIATION 9.88 | 61.38 year STANDARD_DEVIATION 8.43 | 56.73 year STANDARD_DEVIATION 10.79 |
| QST Thermal Pain Threshold | 40.59 Celsius STANDARD_DEVIATION 4.51 | 43.01 Celsius STANDARD_DEVIATION 2.44 | 41.8 Celsius STANDARD_DEVIATION 3.75 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 3 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 5 Participants | 6 Participants |
| Sex: Female, Male Female | 6 Participants | 4 Participants | 10 Participants |
| Sex: Female, Male Male | 1 Participants | 4 Participants | 5 Participants |
| Subject Pain Rating | 4.57 scale 0-10 STANDARD_DEVIATION 2.23 | 4.14 scale 0-10 STANDARD_DEVIATION 2.61 | 4.36 scale 0-10 STANDARD_DEVIATION 2.34 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 8 |
| other Total, other adverse events | 0 / 7 | 0 / 8 |
| serious Total, serious adverse events | 0 / 7 | 0 / 8 |
Outcome results
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.
Time frame: assessed during and immediately after the single 30-minute taVNS session, Post 30-minute taVNS reported
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Auricular Neurostimulation (Active) | Thermal Pain Threshold | 41.84 Celsius | Standard Deviation 5.14 |
| Auricular Neurostimulation (Sham) | Thermal Pain Threshold | 42.51 Celsius | Standard Deviation 2.66 |
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).
Time frame: assessed during and immediately after the single 30-minute taVNS session, Post 30-minute taVNS reported
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Auricular Neurostimulation (Active) | Subjective Pain Ratings | 4.00 Scale 0-10 | Standard Deviation 2.45 |
| Auricular Neurostimulation (Sham) | Subjective Pain Ratings | 3.57 Scale 0-10 | Standard Deviation 2.3 |