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NOT YET RECRUITING
NCT07696988
NA

PNS to Improve Vascular Function and Limb Health in Veterans

Sponsor: VA Office of Research and Development

View on ClinicalTrials.gov

Summary

Establishing a sensitive, scalable physiological test for neurovascular reflex integrity and investigating whether targeted peripheral neural stimulation can enhance perfusion and vasodilatory responsiveness.

Official title: Peripheral Neural Stimulation to Improve Microvascular Function and Limb Health in Veterans With Diabetic Peripheral Neuropathy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

42

Start Date

2026-11-02

Completion Date

2030-05-30

Last Updated

2026-07-10

Healthy Volunteers

Yes

Interventions

DEVICE

Chronically Implanted Neural and Muscular Interface

The implanted neural and and muscular interface will be used to characterize neurovascular reflex testing (thermal axon reflex \& pressure-induced vasodilation) and microvascular imaging using Laser Doppler Flowmetry and PAI. Reflex responses will be evaluated under baseline and stimulation conditions (sham, tonic, biomimetic), with direct stimulation performed by the CFINE cohort for modality comparison. Structural-functional relationships will be modeled by integrating metrics from PAI with reflex outcomes.

DEVICE

Peripheral Nerve Stimulation (PNS)

The cutaneous peripheral nerve stimulation interface will be used to characterize neurovascular reflex testing (thermal axon reflex \& pressure-induced vasodilation) and microvascular imaging using Laser Doppler Flowmetry and PAI. Reflex responses will be evaluated under baseline and stimulation conditions (sham, tonic, biomimetic). Structural-functional relationships will be modeled by integrating metrics from PAI with reflex outcomes.

Locations (1)

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, United States