HIV Associated PolyneuropathyNCT07822932
Auricular Vagus Nerve Stimulation Mechanisms for HIV-Associated Peripheral Neuropathy
A study testing Transcutaneous Auricular Vagus Nerve Stimulation (AVNS) in people with HIV Associated Polyneuropathy, run by University of Miami at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- HIV Associated Polyneuropathy
- What is being tested?
- Transcutaneous Auricular Vagus Nerve Stimulation (AVNS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to 30 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Christine E Lynn Rehabilitation Center
Miami, Florida, 33136
Richard A Martinez, MS, 305-284-2359, rxm1388@med.miami.edu
Marlon L Wong, PT, PhD, mwong2@miami.edu
About this study
Official title: 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.
- Conditions
- HIV Associated Polyneuropathy
- Being tested
- Transcutaneous Auricular Vagus Nerve Stimulation (AVNS)
- Keywords
- HIV-Associated Peripheral Neuropathy, Neuropathic pain, Auricular Vagus Nerve Stimulation, Vagus Nerve Stimulation, Neuromodulation, Aging, Heart Rate Variability, Quantitative Sensory Testing, Neuroinflammation, Corticospinal Excitability
- Medical subject headings
- Neuralgia, Neuroinflammatory Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Auricular Vagus Nerve Stimulation (AVNS)Device
Also called Digitimer DS8R
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.
| Study group | Role | What they receive |
|---|---|---|
| Auricular Vagus Nerve (AVNS) Group | Experimental | 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. Receives: Device: Transcutaneous Auricular Vagus Nerve Stimulation (AVNS) |
| Waitlist Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline (Day 0), pre/post each intervention session (Days 1-13), and post-trial (Day 14)
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (Day 0), Post-trial (Day 14)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study startNov 2026 (estimated)
- Primary completion30 Aug 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV Associated PolyneuropathyStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marlon Wong, University of Miami
- Investigators
- Marlon L. Wong, PT, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07822932
- Sponsor's protocol ID
- 20260653
- Other IDs
- 1R21NS149935-01
- Status last verified
- Oct 2026
- First submitted
- 10 Sep 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified participant-level clinical, physiological, biomarker, and patient-reported outcome data underlying published study findings.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanistic Modulation of HIV-Associated Peripheral Neuropathy in Older Adults Via Auricular Vagus Nerve Stimulation
- ClinicalTrials.gov ID
- NCT07822932
- Acronym / sponsor ID
- 20260653
- Conditions
- HIV Associated Polyneuropathy
- Keywords
- HIV-Associated Peripheral Neuropathy, Neuropathic pain, Auricular Vagus Nerve Stimulation, Vagus Nerve Stimulation, Neuromodulation, Aging, Heart Rate Variability, Quantitative Sensory Testing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Nov 2026 (estimated)
- Primary completion
- 30 Aug 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 16 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Auricular Vagus Nerve (AVNS) Group | Experimental | Device: Transcutaneous Auricular Vagus Nerve Stimulation (AVNS)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. |
| Waitlist Control | No intervention | –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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous Auricular Vagus Nerve Stimulation (AVNS)Also: Digitimer DS8RTranscutaneous 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. | Device | Auricular Vagus Nerve (AVNS) Group |
Primary outcome
Change in Short Interval intraCortical Inhibition (SICI)
Time frame: 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)
Time frame: Baseline (Day 0), pre/post each intervention session (Days 1-13), and post-trial (Day 14)
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.
8 secondary outcomes
Change in Neuropathic Pain Symptom Severity Inventory (NPSI)
Time frame: Baseline (Day 0), post-trial (Day 14)
Change in Neuropathic Symptom Intensity (Numeric Rating Scale)
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)
Time frame: Baseline (Day 0), Post-trial (Day 14)
Change in Serum Interleukin-1 Beta (IL-1β)
Time frame: Baseline (Day 0), Post-trial (Day 14)
Change in Serum Tumor Necrosis Factor-Alpha (TNF-α)
Time frame: Baseline (Day 0), Post-trial (Day 14)
Change in Serum Interleukin-6 (IL-6)
Time frame: Baseline (Day 0), Post-trial (Day 14)
Change in Wind-Up Ratio (WUR)
Time frame: Baseline (Day 0), Pre/post each treatment session (Days 1-13), Post-trial (Day 14)
Change in Conditioned Pain Modulation (CPM)
Time frame: Baseline (Day 0), Post-trial (Day 14)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified participant-level clinical, physiological, biomarker, and patient-reported outcome data underlying published study findings.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marlon L. Wong, PT, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Auricular Vagus Nerve Stimulation (AVNS) in people with HIV Associated Polyneuropathy, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marlon L Wong, PT, PhD (3052842670, mwong2@miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Short Interval intraCortical Inhibition (SICI) (time frame: Baseline (Day 0), Post-trial (Day 14)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.