Abstract
AbstractBackgroundThere is a strong correlation between Alzheimer’s Disease (AD) and poor cerebral blood flow (CBF). RenewTM NCP‐5 is an FDA‐cleared, external counterpulsation ECP device, which chronically improves coronary and peripheral vascular hemodynamics, and may provide the same benefit for cerebral perfusion and cognitive function. Accurate measurements of CBF, such as arterial spin labelling MRI, can be extremely costly, and alternative solutions may be less accurate. The moorVMS‐NIRS uses the established spatially resolved spectroscopy technique to measure tissue oxygen saturation (SO2) and relative concentrations of oxygenated haemoglobin (oxyHb) and deoxygenated haemoglobin (deoxyHb) in human tissueMethodA subset analysis of patients enrolled in the RenewTM NCP‐5‐1001 research protocol (NCT03721705), will be monitored with the VMS‐NIRS device over the course of two 60 minute treatments, first during randomization then during week 24, which mark the start and end of their treatment regimen, respectively. The moorVMS‐NIRS measures oxygenation using a probe which is placed in contact with the skin over patients’ temples. Each probe consists of a detector head which contains two identical photodiodes and emitter head which contains near infrared LEDs emitting light at approximately 750 nm and 850 nm. To ensure replicable measurements from randomization to week 24. A BraiNet cap is used to mark the probe location.ResultIndividual patient data will be analyzed using both the individual patient as their own control (at randomization versus week 24) as well as a therapeutic efficacy comparison between patients randomized to the treatment group versus sham therapy. Acute and chronic changes will be monitored as continuous measurements will be taken during each treatment session. Arterial spin labeling MRI will be measured within 3 weeks of randomization and again within 3 days of the week 24 visit.ConclusionMRI results may be able to corroborate and further validate the use of the moorVMS‐NIRS device as an accurate, cost‐effective measurement to detect changes in levels of brain oxygenation for future trials.
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