At a glance
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Pilot Clinical Investigation Evaluating the Safety and Performance of RGn550 in Treating Sportspeople Suffering From Acute Concussion Syndrome - A Prospective, Comparative, Randomized, Simple-blinded, Monocentric Investigation [RGncon Investigation]
In Brief
A clinical study evaluating RGn550 5 Hz-PWM and RGn550 10 Hz-PWM for Acute Concussion Syndrome. Completed, enrolled 50 participants across 1 site.
Detailed Summary
This is a controlled investigation, with randomization of the patients, which aims at evaluating the safety and performance of device RGn550 in treating sportspeople suffering from acute concussion syndrome. RGn550 is a non-invasive medical device which is applied on the head (helmet). It combines 2 technologies: * PhotoBioModulation (PBM), which involves exposure to light from the red to near-infrared wavelengths using lasers and Light Emitting Diodes (LEDs) * Static Magnetic Stimulation (SMS), which consists in the application of a static magnetic field. Considering previous investigations, this innovative technology could reduce brain inflammation implicated in concussion syndrome.
Study Details
Timeline
Interventions
RGn550 with a 5 Hz-pulsed wave mode light emission
RGn550 with a 10 Hz-pulsed wave mode light emission