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PNS to Improve Vascular Function and Limb Health in Veterans

Not Yet RecruitingNA

Sponsor: VA Office of Research and Development

Conditions: Lower Limb Amputees, Diabetes

Interventions: Chronically Implanted Neural and Muscular Interface, Peripheral Nerve Stimulation (PNS)

Countries: United States

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

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

Inclusion Criteria - All Participants:

* English-speaking
* Veteran

Inclusion Criteria - Diabetic Peripheral Neuropathy (DPN) Participants:

* Confirmed diagnosis of type 1 or type 2 diabetes mellitus for at least 5 years
* Clinical signs and/or symptoms consistent with diabetic peripheral neuropathy Or confirmation of neuropathy via physical exam

Inclusion Criteria - Lower Limb Amputees:

* Unilateral transtibial or transfemoral amputation
* Medically stable for at least 3 months
* For the designated subset of the limb-loss cohort (n = 6): implanted with C-FINEs on the sciatic and/or tibial nerves

Exclusion Criteria:

Exclusion Criteria - All Participants:

* Severe neurological disorders impairing ambulation
* Visual or hearing impairments interfering with study participation
* Cardiovascular or respiratory conditions posing risk during participation
* Cognitive or psychiatric conditions compromising informed consent
* Participation in other clinical trials interfering with outcomes
* Pregnancy
* History of photosensitivity or known sensitivity to laser light

Additional Exclusion Criteria - Amputees:

* Active skin breakdown or infection at residual limb
* Significant phantom or residual limb pain interfering with study procedures
* Bilateral lower-limb amputation

Locations (1)

Cleveland, Ohio, United States