Investigate the Anti-pain Effect of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) in Patients With Chronic Post-stroke Upper Extremity Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Thermal Pain Threshold
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Thermal Pain Threshold
时间窗: 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.
次要结局
- Subjective Pain Ratings(assessed during and immediately after the single 30-minute taVNS session, Post 30-minute taVNS reported)