NCT Number: NCT07696988
Establishing a sensitive, scalable physiological test for neurovascular reflex integrity and investigating whether targeted peripheral neural stimulation can enhance perfusion and vasodilatory responsiveness.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Cleveland, Ohio, 44106-1702, United States
Aarika Sheehan, DPT
CONTACT
(216) 791-3800 ext. 65832
Hamid Charkhkar, PhD
PRINCIPAL_INVESTIGATOR
Jessica R Jarvela, MS BS
CONTACT
216-791-3800 ext. 63801
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Inclusion criteria
- All Participants:
Inclusion criteria
- DPN Participants:
Inclusion criteria
- Lower Limb Amputees:
Exclusion criteria
Exclusion criteria
- All Participants:
Additional Exclusion Criteria - Amputees:
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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: baseline and visits 1-15 until study completion, average 1 year
From photoacoustic imaging, hemoglobin oxygenation is derived and compared across different study conditions
Contact information is provided by the study sponsor or research team.
Hamid Charkhkar, PhD
CONTACT
(216) 791-3800 ext. 62924
Jessica R Jarvela, MS BS
CONTACT
(216) 791-3800 ext. 63801
VA Office of Research and Development
Fed
Peripheral Neural Stimulation to Improve Microvascular Function and Limb Health in Veterans With Diabetic Peripheral Neuropathy
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07388537
Body Weight, Diabetes
Bethesda, Maryland, United States
View Trial DetailsNCT07313787
Diabetes, Diabetes Mellitus
Bethesda, Maryland, United States
View Trial DetailsNCT06645769
Diabetes, Diabetes Mellitus
View Trial DetailsNCT07723222
Apnea, Cardiovascular Autonomic Neuropathy (CAN)
View Trial Details