Mechanistic Modulation of HIV-Associated Peripheral Neuropathy in Older Adults Via Auricular Vagus Nerve Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in Short Interval intraCortical Inhibition (SICI)
研究概览
简要总结
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Transcutaneous Auricular Vagus Nerve Stimulation (AVNS) (Device)
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.
结局指标
主要结局
Change in Short Interval intraCortical Inhibition (SICI)
时间窗: 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.
Change in Root Mean Square of Successive Differences (RMSSD)
时间窗: (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.
次要结局
- Change in Neuropathic Pain Symptom Severity (NPSI)(Baseline (Day 0), post-trial (Day 14))
- Change in Neuropathic Symptom Intensity (Numeric Rating Scale)(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)(Baseline (Day 0), Post-trial (Day 14))
- Change in Serum Interleukin-1 Beta (IL-1β)(Baseline (Day 0), Post-trial (Day 14))
- Change in Serum Tumor Necrosis Factor-Alpha (TNF-α)(Baseline (Day 0), Post-trial (Day 14))
- Change in Wind-Up Ratio (WUR)(Baseline (Day 0), Pre/post each treatment session (Days 1-13), Post-trial (Day 14))
- Change in Conditioned Pain Modulation (CPM)(Baseline (Day 0), Post-trial (Day 14))
研究者
Marlon Wong
Associate Professor of Clinical Medicine
University of Miami