Feasibility of Trans-Carotid Energy Transmission Using a Vibrating Stroke Gun for Treatment of Acute Ischemic Stroke. A Single-Subject Exploratory Study of Device to Vessel Coupling.
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Abstract
Acute Ischemic Stroke (AIS) remains a leading cause of death and serious disability, with reperfusion rates by IntraVenous Thrombolytic Therapy (IV-TT) constrained by slow drug delivery to the TICI 0 vessel. Pre-clinical modeling has suggested that transcarotid mechanical compressions at (20 - 24 cycles/second, 2 mm stroke) could generate downstream intracranial pressure fluctuations capable of disrupting clots, which informed the development of Carotid Vibro-Compressions (CVCs) for AIS. In a prior feasibility study, we applied CVCs (~ 30 c/s, 1 mm stroke) to 15 healthy volunteers, showing safe transmission of flow pulses to the intracranial cerebral arteries, but delivery was inconsistent, likely due to challenges in device-to-vessel coupling. Hence, in this single -subject exploratory work, CVC transmissions were reassessed, but this time using a more powerful “Vibrating Stroke Gun” (VSG) (20 - 42 cycles/second, ~ 2 mm stroke), and with an auditory feedback method to maintain sustained contact between the device and the carotid during applications. This time TransCranial Doppler (TCD) to the Middle Cerebral Artery (MCA) revealed comparatively reliable, low amplitude flow pulses during VSG application, both ipsilaterally and contralaterally, with the 20 - 28 c/s range providing the most prominent signals. It is hypothesized that gentle “choppy” hemodynamic perturbations instigated by CVCs would create transient, “shaken and stirred” pressure gradients and convection currents, to facilitate diffusion of systemically administered thrombolytics into thrombo-occluded TICI 0 vessels. Moreover, CVCs may also augment shear-mediated clot erosion, and stimulate nitric oxide release, thereby promoting a localized vasodilation response. Conclusion: The VSG, with a method to ensure device-to-vessel coupling, demonstrates reliable transcarotid energy transmission to the MCA in a healthy volunteer, supporting its potential feasibility for further testing as an IV-TT adjuvant for AIS. Optimized operational parameters and delivery methods are defined to guide future preclinical and clinical work in this field.
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