Pilot Clinical Investigation Evaluating the Safety and Performance of RGn550 in Treating Sportspeople Suffering From Acute Concussion Syndrome

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.

Inclusion Criteria:Male or female aged at least 18 years oldSuffering from concussion syndrome resulting from a shock that occurred during sport practice less than 72h ago, as confirmed by neurological examination via the Head Injury Assessment - Form 3 (HIA3) toolAffiliated to French social securityWho provided a dated and signed informed consent form.Non-inclusion Criteria:Patient protected by a French legal measure ("sauvegarde de justice", "tutelle" or "curatelle")Patient not able to express his/her consentPatient deprived of liberty or hospitalized without consentWoman who is pregnant or breastfeeding, or who plans to become pregnant or breastfeeding during the investigation, or who has the capacity to conceive but is not using a reliable contraceptive method as deemed by the investigatorPatient living in a medical facilityPatient who experienced a surgery at the treatment application area (head) within 3 months prior to inclusionPatient with skin lesions on the treatment application area (head)Patient with a short-term life-threatening pathology (e.g., evolving cancer; non-stable heart failure; severe hepatic, renal or respiratory failure, etc.)Patient diagnosed with a heart attack within 3 months prior to inclusionPatient implanted with ferromagnetic materialPatient implanted with a pacemakerPatient with a risk of epileptic seizure or other non-degenerative central nervous system diseasesPatient with major physical or neurosensorial disorders that may interfere with assessmentsPatient with chronic psychosis or psychotic episodesPatient addicted to alcohol or drugsPatient treated with antidepressant or benzodiazepinePatient who participated to another investigation/study involving the use of an investigational medical device/drug within the 30 days prior inclusionPatient not able to meet treatment sessions as deemed by the investigatorPatient not able to complete requested investigation assessments as deemed by the investigator.