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

Award Number: R21NS149935
ORGANIZATION: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2026
PERIOD OF PERFORMANCE END DATE: 08/31/2028

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Mechanistic Modulation of HIV-Associated Peripheral Neuropathy in Older Adults via Auricular Vagus Nerve Stimulation - PROJECT SUMMARY Peripheral neuropathy (PN) affects up to 60% of people living with HIV (PLWH), with aging compounding declines in sensory and autonomic function. HIV-associated peripheral neuropathy (HIV-PN) arises from neuroinflammation, central nervous system disinhibition, and autonomic dysregulation, yet mechanistic biomarkers and effective interventions remain elusive. This R21 project aims to characterize the mechanistic pathways through which auricular vagus nerve stimulation (AVNS), a non-invasive neuromodulation technique, may modulate HIV-PN in aging PLWH. We will conduct a randomized, waitlist-controlled mechanistic trial in 70 adults aged ≥50 with chronic HIV-PN. The study will assess changes in heart rate variability (HRV), short interval intracortical inhibition (SICI), wind- up ratio (WUR), conditioned pain modulation (CPM), and serum neuroinflammatory markers (NfL, IL-1β, TNF- α, IL-6) following AVNS. Machine learning approaches will be used to develop multivariate biomarker models predictive of individual mechanistic response. The innovation lies in integrating central and peripheral biomarkers, leveraging machine learning for individualized mechanistic profiling, and focusing on within-person variability rather than group averages. The study will provide foundational data for future mechanistic trials and inform precision neuromodulatory interventions for HIV-PN, a debilitating condition disproportionately affecting aging PLWH. This research aligns with NINDS and NIH Office of AIDS Research priorities to elucidate mechanisms underlying neurological disorders in the context of HIV and aging. Results will advance understanding of neuroimmune interactions, inform personalized interventions, and address critical gaps in the management of HIV-PN in older adults.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $422,125 )
2026	2026	UNIVERSITY OF MIAMI	1320 S DIXIE HWY STE 1200	CORAL GABLES	FL	33146	MIAMI-DADE	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	1	9/1/2026	NEW	$422,125
														Subtotal = $422,125

Grand Total All Awards = $422,125

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

Award Number: R21NS149935

ORGANIZATION: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/01/2026

PERIOD OF PERFORMANCE END DATE: 08/31/2028

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