PNS to Improve Vascular Function and Limb Health in Veterans
8. juli 2026 opdateret af: VA Office of Research and Development
Peripheral Neural Stimulation to Improve Microvascular Function and Limb Health in Veterans With Diabetic Peripheral Neuropathy
Establishing a sensitive, scalable physiological test for neurovascular reflex integrity and investigating whether targeted peripheral neural stimulation can enhance perfusion and vasodilatory responsiveness.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The overarching goal of this project is to define how targeted afferent activation can be used to restore impaired neurovascular reflexes, improve skin perfusion, and ultimately prevent further decline in limb health in Veterans.
By integrating functional and structural imaging with neural modulation, this work will establish foundational evidence for diagnostic and therapeutic strategies aimed at early detection of neurovascular decline and prevention of tissue breakdown in both Diabetic Peripheral Neuropathy (DPN) and residual-limb contexts.
Furthermore, this work will establish the feasibility of preventing or delaying the mechanical trauma of the insensate distal limb which invariably leads to deep pressure injuries, infections, and amputation in Veterans with DPN.
The findings have the potential to transform care by enabling earlier diagnosis, improving neurovascular responsiveness, and optimizing neuromodulation protocols to prevent skin complications, delay progression toward amputation, and improve quality of life in Veterans with DPN or limb loss.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
42
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Jessica R Jarvela, MS BS
- Telefonnummer: 63801 (216) 791-3800
- E-mail: Jessica.Jarvela@va.gov
Undersøgelse Kontakt Backup
- Navn: Hamid Charkhkar, PhD
- Telefonnummer: 62924 (216) 791-3800
- E-mail: Hamid.Charkhkar@va.gov
Studiesteder
-
-
Ohio
-
Cleveland, Ohio, Forenede Stater, 44106-1702
- Louis Stokes VA Medical Center, Cleveland, OH
-
Kontakt:
- Aarika Sheehan, DPT
- Telefonnummer: 65832 (216) 791-3800
- E-mail: Aarika.Sheehan@va.gov
-
Kontakt:
- Jessica R Jarvela, MS BS
- Telefonnummer: 63801 216-791-3800
- E-mail: Jessica.Jarvela@va.gov
-
Ledende efterforsker:
- Hamid Charkhkar, PhD
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Beskrivelse
Inclusion Criteria:
Inclusion Criteria - All Participants:
- English-speaking
Inclusion Criteria - 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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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
|
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.
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.
|
|
Eksperimentel: Peripheral nerve stimulation
30 able body participants and 12 participants with unilateral lower-limb loss with receive peripheral nerve stimulation
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Cutaneous Vascular Conductance
Tidsramme: baseline and visits 1-15 until study completion, average 1 year
|
Autonomic reflex testing including thermal axon reflex and pressure induced vasoconstriction will be applied.
The cutaneous blood flow in the lower limb will be measured using laser doppler flowmetry.
The flux is divided by mean arterial pressure to calculate cutaneous vascular conductance.
This provides a physiologically relevant metric of microvascular control by accounting for systemic pressure fluctuations
|
baseline and visits 1-15 until study completion, average 1 year
|
|
Vessel Density
Tidsramme: baseline and visits 1-15 until study completion, average 1 year
|
Defined as the percentage of tissue volume occupied by vascular structures.
The investigators use photoacoustic imaging of microvascular structure to quantify microvascular structural integrity at distal and proximal skin sites.
From the reconstructed volumetric data, the investigators will extract the vessel density
|
baseline and visits 1-15 until study completion, average 1 year
|
|
Tissue Oxygen Saturation
Tidsramme: baseline and visits 1-15 until study completion, average 1 year
|
Tissue oxygen saturation or sO2 will be measured during different conditions of the study such as thermal axon reflex and pressure induced vasoconstriction using reflectance spectroscopy
|
baseline and visits 1-15 until study completion, average 1 year
|
|
Mean Vessel Diameter
Tidsramme: baseline and visits 1-15 until study completion, average 1 year
|
Calculated from the cross-sectional profiles of resolved vessels obtained from the photoacoustic imaging of microvascular structures
|
baseline and visits 1-15 until study completion, average 1 year
|
|
Hemoglobin Oxygenation
Tidsramme: baseline and visits 1-15 until study completion, average 1 year
|
From photoacoustic imaging, hemoglobin oxygenation is derived and compared across different study conditions
|
baseline and visits 1-15 until study completion, average 1 year
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Hamid Charkhkar, PhD, Louis Stokes VA Medical Center, Cleveland, OH
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
2. november 2026
Primær færdiggørelse (Anslået)
30. maj 2030
Studieafslutning (Anslået)
30. maj 2030
Datoer for studieregistrering
Først indsendt
23. juni 2026
Først indsendt, der opfyldte QC-kriterier
8. juli 2026
Først opslået (Faktiske)
10. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
10. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- RRD5-006-25W
- RD001968-01 (Andet bevillings-/finansieringsnummer: VA Merit)
- 1584038 (Anden identifikator: IRB)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ja
produkt fremstillet i og eksporteret fra U.S.A.
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .