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Auricular Vagus Nerve Stimulation Mechanisms for HIV-Associated Peripheral Neuropathy

2026年9月10日 更新者：Marlon Wong、University of Miami

Mechanistic Modulation of HIV-Associated Peripheral Neuropathy in Older Adults Via Auricular Vagus Nerve Stimulation

This study looks at a non-invasive ear stimulation treatment to better understand nerve pain in people living with HIV. The study aims to assess how the body and nervous system respond to this treatment, including changes in heart function and pain signals. The goal is to learn how future treatments for nerve pain may be improved.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

70

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Marlon L Wong, PT, PhD
  • 电话号码：3052842670
  • 邮箱：mwong2@miami.edu

研究联系人备份

学习地点

  • 美国
    • Florida
      • Miami、Florida、美国、33136
        • Christine E Lynn Rehabilitation Center
        • 接触：
        • 首席研究员：
          • Marlon L. Wong, PT, PhD
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Established HIV infection
  • Glove/stocking dysesthesias lasting for ≥3 months
  • HIV-associated peripheral neuropathy (HIV-PN) related symptoms ≥4 (on a scale of 0-10) within the last week
  • Stable medical care (i.e., no changes in Antiretroviral Therapy or pain medication within 2 months of enrollment)
  • Able to read the consent form, demonstrate understanding of study procedures and requirements, and independently provide written informed consent

Exclusion Criteria:

  • Unstable cardiac disease
  • Implanted electronic or magnetic devices (e.g., pacemaker, cochlear implants, medication pumps, and other implanted neurostimulation systems)
  • Head or neck cancer or metastases
  • Recent ear trauma or metal implants in the head
  • History of epilepsy, unprovoked seizure, stroke, brain tumor, significant traumatic brain injury, prior intracranial surgery, or other neurological condition associated with increased seizure risk
  • Active or uncontrolled comorbidities that independently cause neuropathy (e.g., recent chemotherapy, uncontrolled diabetes with documented neuropathic complications)
  • Clinical evidence of non-HIV neuropathy (e.g., neuropathic symptoms predating HIV diagnosis, uncontrolled diabetes)
  • Known allergy to tape/adhesive
  • Ferromagnetic or non-MRI-compatible metal in the head, neck, eye, or cranial region, including aneurysm clips, retained metal fragments, bullets, shrapnel, or other metallic implants not demonstrated to be TMS-compatible.
  • Pregnancy or actively breast feeding

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：Auricular Vagus Nerve (AVNS) Group
Participants in this group will receive 6 sessions of transcutaneous auricular vagus nerve stimulation (AVNS) over 2 weeks. Each stimulation session will last approximately 90 minutes at monophasic pulses.
设备：Transcutaneous Auricular Vagus Nerve Stimulation (AVNS)
Transcutaneous auricular vagus nerve stimulation (taVNS) will be administered at the cymba concha using hydrogel electrodes and a Digitimer DS8R biphasic constant-current stimulator. Participants will receive 90-minute stimulation sessions consisting of monophasic pulses (pulse width: 500 microseconds; frequency: 25 Hz; duty cycle: 50%). Stimulation intensity will be set at 200% of the participant's sensory perception threshold and may be adjusted up to 5 milliamperes (mA) while remaining below the pain threshold.
其他名称：
  • Digitimer DS8R
无干预：Waitlist Control
Participants in this group will not receive an intervention. Participants will be placed on a waitlist to try the intervention and will be assessed pre and post the 2-week waiting period. No stimulation device is provided, and no active treatment or experimental procedure is administered during the 14-day waitlist period.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in Short Interval intraCortical Inhibition (SICI)
大体时间：Baseline (Day 0), Post-trial (Day 14)
Short-interval intracortical inhibition (SICI) will be assessed using paired-pulse transcranial magnetic stimulation (TMS) with a MagPro X100 stimulator. Change in SICI will be calculated as the difference between post-intervention and pre-intervention measurements. Negative values indicate increased intracortical inhibition.
Baseline (Day 0), Post-trial (Day 14)
Change in Root Mean Square of Successive Differences (RMSSD)
大体时间：(Days 1-13), Post-trial (Day 14)
The root mean square of successive differences (RMSSD), will be assessed using a three-lead electrocardiogram (ECG). Change in RMSSD will be calculated as the difference between post-intervention and baseline measurements. Higher RMSSD values indicate greater parasympathetic (vagal) activity and heart rate variability.
(Days 1-13), Post-trial (Day 14)

次要结果测量

结果测量
措施说明
大体时间
Change in Neuropathic Pain Symptom Severity (NPSI)
大体时间：Baseline (Day 0), post-trial (Day 14)
Neuropathic pain symptom severity will be assessed using the Neuropathic Pain Symptom Inventory (NPSI), a patient-reported questionnaire that evaluates 10 neuropathic pain symptoms on an 11-point numeric scale ranging from 0 (no symptom) to 10 (worst symptom severity imaginable). The NPSI also includes 2 items assessing the duration of ongoing pain and the frequency of pain attacks. Higher scores indicate greater neuropathic pain symptom severity.
Baseline (Day 0), post-trial (Day 14)
Change in Neuropathic Symptom Intensity (Numeric Rating Scale)
大体时间：Baseline (Day 0), pre/post each treatment session (Days 1-13), post-trial (Day 14), and at follow up (Day 45)
Neuropathic symptom intensity will be assessed using the 0-10 Numeric Rating Scale (NRS). Participants will rate the average severity of HIV-associated peripheral neuropathy symptoms from 0 (not bothersome) to 10 (worst imaginable). Higher scores indicate greater symptom intensity.
Baseline (Day 0), pre/post each treatment session (Days 1-13), post-trial (Day 14), and at follow up (Day 45)
Change in Serum Neurofilament Light Chain (NfL)
大体时间：Baseline (Day 0), Post-trial (Day 14)
Serum neurofilament light chain (NfL) will be measured from non-fasted venous blood samples. NfL concentrations (pg/mL) will be quantified using enzyme-linked immunosorbent assay (ELISA). Change in NfL will be calculated as the difference between post-intervention and baseline serum concentrations. Higher concentrations indicate greater neuroaxonal injury.
Baseline (Day 0), Post-trial (Day 14)
Change in Serum Interleukin-1 Beta (IL-1β)
大体时间：Baseline (Day 0), Post-trial (Day 14)
Serum interleukin-1 beta (IL-1β) will be measured from non-fasted venous blood samples. IL-1β concentrations (pg/mL) will be quantified using enzyme-linked immunosorbent assay (ELISA). Change in IL-1β will be calculated as the difference between post-intervention and baseline serum concentrations. Higher concentrations indicate greater systemic inflammation.
Baseline (Day 0), Post-trial (Day 14)
Change in Serum Tumor Necrosis Factor-Alpha (TNF-α)
大体时间：Baseline (Day 0), Post-trial (Day 14)
Serum Tumor Necrosis Factor-Alpha (TNF-α) will be measured from non-fasted venous blood samples. TNF-α concentrations (pg/mL) will be quantified using enzyme-linked immunosorbent assay (ELISA). Change in TNF-α will be calculated as the difference between post-intervention and baseline serum concentrations. Higher concentrations indicate greater systemic inflammation.
Baseline (Day 0), Post-trial (Day 14)
Change in Wind-Up Ratio (WUR)
大体时间：Baseline (Day 0), Pre/post each treatment session (Days 1-13), Post-trial (Day 14)
Wind-up ratio (WUR), will be assessed using responses to repeated pinprick stimuli. Change in WUR will be calculated as the difference between post-intervention and baseline measurements. Lower WUR values indicate reduced temporal summation and decreased central sensitization.
Baseline (Day 0), Pre/post each treatment session (Days 1-13), Post-trial (Day 14)
Change in Conditioned Pain Modulation (CPM)
大体时间：Baseline (Day 0), Post-trial (Day 14)
Conditioned pain modulation (CPM), will be assessed using a cold pressor conditioning stimulus (1 to 4°C for 60 seconds) and pressure pain threshold (PPT) testing on the forearm. The CPM effect will be calculated as the percent change in PPT from before to after the conditioning stimulus (%ΔPPT). Higher CPM values indicate greater endogenous pain inhibition.
Baseline (Day 0), Post-trial (Day 14)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of Miami

调查人员

  • 首席研究员：Marlon L. Wong, PT, PhD、University of Miami

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年11月1日

初级完成 (估计的)

2028年8月30日

研究完成 (估计的)

2028年9月30日

研究注册日期

首次提交

2026年9月10日

首先提交符合 QC 标准的

2026年9月10日

首次发布 (实际的)

2026年9月16日

研究记录更新

最后更新发布 (实际的)

2026年9月16日

上次提交的符合 QC 标准的更新

2026年9月10日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 20260653
  • 1R21NS149935-01 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

De-identified participant-level clinical, physiological, biomarker, and patient-reported outcome data underlying published study findings.

IPD 共享时间框架

By publication of primary study findings or no later than the end of the award period

IPD 共享访问标准

The study protocol, statistical analysis plan, informed consent form template, and analytic code will be made available upon publication of the primary results or study completion, consistent with the approved NIH Data Management and Sharing Plan. Materials will be shared through appropriate repositories and/or institutional platforms in accordance with participant privacy protections and applicable policies.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会
  • 分析代码

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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