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NOT YET RECRUITING
NCT07804199
NA

taVNS in Veterans With Knee OA (AVAHCS)

Sponsor: VA Office of Research and Development

View on ClinicalTrials.gov

Summary

The objectives of this study are to identify an optimal transcutaneous auricular vagus nerve stimulation (taVNS) dosing regimen for pain relief and anti-inflammatory effects in Veterans with knee osteoarthritis (OA), compared to corticosteroid injection (CSI), and lay the groundwork for future combinatorial therapies with cell-based approaches. The population for this study is Veterans with osteoarthritis (OA). This single-center, randomized pilot study will enroll participants with knee OA, who will be allocated to CSI (n=10), high-dose taVNS (n=15; 1-2 hours/day, 7 days/week), or low-dose taVNS (n=15; 30-60 min/day, 3 days/week) for 12 weeks. Synovial fluid and blood samples will be collected at baseline, 4, and 12 weeks for biomarker analysis (pro-inflammatory cytokines: TNF-, IL-6, IL-1 ; anti-inflammatory mediators: IL-10, TGF-). The approximate study duration for each individual participant is 12 weeks of treatment with assessment visits at baseline, one month, and three months. Participants will be recruited at the Atlanta VA. The anticipated total enrollment is 40 participants. No specimens or data will be banked for future research use. Informed consent will be obtained from participants in person via signatures on written informed consent forms.

Official title: Optimizing Home-Based Auricular Vagus Nerve Stimulation for Pain, Function, and Inflammation in Veterans With Knee Osteoarthritis: A Randomized Pilot Dose-Finding Study (AVAHCS) (F4845-C)

Key Details

Gender

All

Age Range

45 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-10-01

Completion Date

2028-01-01

Last Updated

2026-09-04

Healthy Volunteers

No

Interventions

DRUG

Methylprednisolone acetate

FDA-approved injection treatment applied to the knee for purposes of KOA pain management.

DEVICE

taVNS

Transcutaneous auricular vagus nerve stimulation (taVNS) is a self-administered, home-based, non-invasive therapy with minimal risk of side effects. Mechanistically, taVNS targets auricular vagal afferents and requires afferent signaling to the nucleus tractus solitarius (NTS) to activate downstream efferent pathways in the central nervous system, including higher brain regions involved in pain processing (Fig 1), exerting anti-nociceptive effects.

Locations (1)

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, United States