PNS to Improve Vascular Function and Limb Health in Veterans

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
VA Office of Research and Development
Study ID
NCT07696988
Status
Not Yet Recruiting

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Conditions

  • Diabetes
  • Lower Limb Amputees

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Chronically Implanted Neural and Muscular Interface — DEVICE
    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.
  • Peripheral Nerve Stimulation (PNS) — DEVICE
    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.

Study Details

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

Key Dates

First listed
Jul 10, 2026
Start date
Nov 2, 2026
Status verified
Jul 2026
Primary completion
May 30, 2030
Completion
May 30, 2030

Study Design

Enrollment
42 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Implanted Neural and Muscular Interface
    6 lower limb loss participants who have already been chronically implanted with neural and muscular interfaces to allow for direct stimulation
  • Experimental: Peripheral nerve stimulation
    30 able body participants and 12 participants with unilateral lower-limb loss with receive peripheral nerve stimulation

Primary Outcome Measure

Cutaneous Vascular Conductance [ Time Frame: baseline and visits 1-15 until study completion, average 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Louis Stokes VA Medical Center, Cleveland, OHClevelandOhio44106-1702
Jessica R Jarvela, MS BS
[email protected]
216-791-3800
Aarika Sheehan, DPT
[email protected]
(216) 791-3800
Hamid Charkhkar, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Louis Stokes VA Medical Center, Cleveland, OH· Cleveland, OH

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