Wong Marlon L, Widerström-Noga Eva, Bolanos Jessica L, Gonzalez Gabriel, Penedo Frank J, Hosein Peter J, Tovin Melissa M, Gonzalez Juan P, McTeague Lisa M
Department of Physical Therapy, Miller School of Medicine, University of Miami, Miami, FL, United States.
The Miami Project to Cure Paralysis, University of Miami, Miami, FL, United States.
Front Pain Res (Lausanne). 2025 Jan 17;5:1516196. doi: 10.3389/fpain.2024.1516196. eCollection 2024.
Peripheral neuropathy (PN) is the most common neurodegenerative disorder, and the primary causes are chemotherapy-induced peripheral neuropathy (CIPN) and diabetic neuropathy (DN). Transcutaneous auricular vagus nerve stimulation (taVNS) is a promising non-pharmacological and non-invasive intervention that targets key pathways involved with PN. However, research is needed to determine the feasibility, acceptability, and effects of taVNS in people with PN. It is also critical that this research on taVNS include the perspectives of Black and Hispanic/Latino patients, who are often underrepresented in research.
This research was comprised of two consecutive studies: a survey and a pilot randomized sham-controlled trial (RCT). The survey assessed symptom burden, management strategies, and interest in taVNS among CIPN patients. The pilot RCT evaluated the feasibility, acceptability, and preliminary effects of taVNS in Black and Hispanic/Latino patients with CIPN or diabetic neuropathy. Participants were recruited from the University of Miami medical system, with culturally sensitive approaches to enhance minority participation.
The survey included 62 respondents, 78% Black or Hispanic/Latino, revealing high symptom burden and significant interest in taVNS (82% expressed moderate to high interest). The pilot RCT enrolled 28 participants, achieving a 42% recruitment rate and 86% retention. taVNS was well tolerated, with no significant adverse effects. Preliminary data indicated a decrease in neuropathic symptoms and an increased heart rate variability (HRV) during active taVNS, suggesting autonomic modulation. Tingling sensation and pain decreased by median values of 2.0 and 1.5, respectively. Additionally, the median values for standard deviation of the RR interval increased from 34.9 (CI = 21.6-44.8) at baseline to 44.8 (CI = 26.5-50.3) during intervention. Exit interviews highlighted positive participant experiences and identified potential barriers, such as protocol length and distrust in medical research.
The findings underscore the need for novel CIPN treatments and demonstrate the feasibility of conducting taVNS research in historically underrepresented populations. High interest in taVNS and successful recruitment and retention rates suggest that culturally sensitive approaches can enhance minority participation in clinical trials. These findings will be used to develop a large clinical trial to determine the efficacy of repeated taVNS in a diverse cohort.
https://clinicaltrials.gov, identifier (NCT05896202).
周围神经病变（PN）是最常见的神经退行性疾病，其主要病因是化疗引起的周围神经病变（CIPN）和糖尿病性神经病变（DN）。经皮耳迷走神经刺激（taVNS）是一种有前景的非药物、非侵入性干预措施，针对与PN相关的关键通路。然而，需要开展研究以确定taVNS在PN患者中的可行性、可接受性和效果。同样至关重要的是，这项关于taVNS的研究应纳入黑人和西班牙裔/拉丁裔患者的观点，他们在研究中往往代表性不足。
本研究由两项连续的研究组成：一项调查和一项试点随机假对照试验（RCT）。该调查评估了CIPN患者的症状负担、管理策略以及对taVNS的兴趣。试点RCT评估了taVNS在患有CIPN或糖尿病性神经病变的黑人和西班牙裔/拉丁裔患者中的可行性、可接受性和初步效果。参与者从迈阿密大学医疗系统招募，采用具有文化敏感性的方法以提高少数群体的参与度。
该调查包括62名受访者，其中78%为黑人和西班牙裔/拉丁裔，结果显示症状负担较重且对taVNS兴趣浓厚（82%表示有中度至高兴趣）。试点RCT招募了28名参与者，招募率为42%，保留率为86%。taVNS耐受性良好，无明显不良反应。初步数据表明，在进行活跃的taVNS期间，神经病变症状有所减轻，心率变异性（HRV）增加，提示自主神经调节。刺痛感和疼痛的中位数分别下降了2.0和1.5。此外，RR间期标准差的中位数从基线时的34.9（CI = 21.6 - 44.8）增加到干预期间的4,4.8（CI = 26.5 - 50.3）。退出访谈突出了参与者的积极体验，并确定了潜在障碍，如方案时长和对医学研究的不信任。
研究结果强调了新型CIPN治疗方法的必要性，并证明了在历史上代表性不足的人群中开展taVNS研究的可行性。对taVNS的高度兴趣以及成功的招募和保留率表明，具有文化敏感性的方法可以提高少数群体参与临床试验的程度。这些研究结果将用于开展一项大型临床试验，以确定重复taVNS在不同队列中的疗效。
