PNS to Improve Vascular Function and Limb Health in Veterans
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development
About this trial
Establishing a sensitive, scalable physiological test for neurovascular reflex integrity and investigating whether targeted peripheral neural stimulation can enhance perfusion and vasodilatory responsiveness.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
English-speaking
Veteran
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Chronically Implanted Neural and Muscular Interface
DeviceThe 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)
DeviceThe 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.
Treatment groups
42 Participants
are divided into 2 treatment groupsGroup A: Implanted Neural and Muscular InterfaceExperimental treatment 2 interventions
Group B: Peripheral nerve stimulationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Cutaneous Vascular Conductance
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
Time frame
baseline and visits 1-15 until study completion, average 1 year2
Vessel Density
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
Time frame
baseline and visits 1-15 until study completion, average 1 year3
Tissue Oxygen Saturation
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
Time frame
baseline and visits 1-15 until study completion, average 1 year4
Mean Vessel Diameter
Calculated from the cross-sectional profiles of resolved vessels obtained from the photoacoustic imaging of microvascular structures
Time frame
baseline and visits 1-15 until study completion, average 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
VA Office of Research and Development
Lead sponsor
Case Western Reserve University
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: