An interventional study of Transcutaneous Auricular Vagus Nerve Stimulation (AVNS) in HIV Associated Polyneuropathy, sponsored by University of Miami. Recruiting at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-10-06.
Sponsored by University of Miami · Not applicable, Interventional, and Treatment
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.
1,100 studies on the registry are indexed under Neuralgia; 241 are open to participants now.
This study's planned enrollment of 70 is above the median of 52 across 831 interventional studies indexed under Neuralgia.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Transcutaneous Auricular Vagus Nerve Stimulation (AVNS)
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.
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.
Also known as: Digitimer DS8R
Change in Short Interval intraCortical Inhibition (SICI)
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.
Time frame: Baseline (Day 0), Post-trial (Day 14)
Change in Root Mean Square of Successive Differences (RMSSD)
The root mean square of successive differences (RMSSD), will be assessed using a three-lead electrocardiogram (ECG) and reported in milliseconds (ms). Higher RMSSD values indicate greater parasympathetic (vagal) activity and heart rate variability.
Time frame: Baseline (Day 0), pre/post each intervention session (Days 1-13), and post-trial (Day 14)
Change in Neuropathic Pain Symptom Severity Inventory (NPSI)
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.
Time frame: Baseline (Day 0), post-trial (Day 14)
Change in Neuropathic Symptom Intensity (Numeric Rating Scale)
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.
Time frame: 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)
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.
Time frame: Baseline (Day 0), Post-trial (Day 14)
Change in Serum Interleukin-1 Beta (IL-1β)
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.
Time frame: Baseline (Day 0), Post-trial (Day 14)
Change in Serum Tumor Necrosis Factor-Alpha (TNF-α)
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.
Time frame: Baseline (Day 0), Post-trial (Day 14)
Change in Serum Interleukin-6 (IL-6)
Serum Interleukin-6 (IL-6) will be measured from non-fasted venous blood samples. IL-6 concentrations (pg/mL) will be quantified using enzyme-linked immunosorbent assay (ELISA). Change in IL-6 will be calculated as the difference between post-intervention and baseline serum concentrations. Higher concentrations indicate greater systemic inflammation.
Time frame: Baseline (Day 0), Post-trial (Day 14)
Change in Wind-Up Ratio (WUR)
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.
Time frame: Baseline (Day 0), Pre/post each treatment session (Days 1-13), Post-trial (Day 14)
Change in Conditioned Pain Modulation (CPM)
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.
Time frame: Baseline (Day 0), Post-trial (Day 14)
Plan to share: Yes — De-identified participant-level clinical, physiological, biomarker, and patient-reported outcome data underlying published study findings.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: By publication of primary study findings or no later than the end of the award period
Access criteria: 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.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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