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

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]

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.

This monocentric investigation is planned to include 50 patients who will be followed up to 52 days.

Patients meeting all eligibility criteria will be randomized on a 1: 1 ratio into one of the two groups differing in terms of light exposure duty cycle (duty cycle is 50%) treatment frequency: RGn550 device with a 5 Hz-pulsed wave mode light emission frequency and RGn550 device with a 10 Hz-pulsed wave mode light emission frequency. The RGn550 device will be applied to the patients during two 20-min treatment sessions at 1 week apart.

Three onsite visits will be performed at the following timepoints:

• Day 0 (D0): Inclusion, randomization (to the 5 Hz-PWM or 10Hz-PWM treatment group) and first treatment session with RGn550
• Day 7 (D7): Second treatment session with RGn550
• Day 52 (D52): Evaluation 45 days after the last treatment session. In addition, at Day 14 (D14), the patient will be asked to remotely assess his/her concussion syndrome symptoms.

At inclusion visit, after verification of the eligibility criteria, data regarding patients will be collected: demographic data, result of pregnancy test for women, concussion history, concomitant medications.

At each visit:

• The patient will be asked to assess his/her concussion syndrome symptoms via the SCAT5 evaluation tool
• The functions possibly affected by the concussion syndrome will be assessed at each visit:

O The executive function via the TMT A&B O The automated oculomotor and oculopostural functions via the NPC, cover test and Maddox Rod test O The balance via static stabilometric tests

•all AEs and device deficiencies will be collected A blood sample will be collected at D0 and D52 to measure blood markers of concussion.

Inclusion Criteria:

• Male or female aged at least 18 years old
• Suffering 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) tool
• Affiliated to French social security
• Who 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 consent
• Patient deprived of liberty or hospitalized without consent
• Woman 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 investigator
• Patient living in a medical facility
• Patient who experienced a surgery at the treatment application area (head) within 3 months prior to inclusion
• Patient 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 inclusion
• Patient implanted with ferromagnetic material
• Patient implanted with a pacemaker
• Patient with a risk of epileptic seizure or other non-degenerative central nervous system diseases
• Patient with major physical or neurosensorial disorders that may interfere with assessments
• Patient with chronic psychosis or psychotic episodes
• Patient addicted to alcohol or drugs
• Patient treated with antidepressant or benzodiazepine
• Patient who participated to another investigation/study involving the use of an investigational medical device/drug within the 30 days prior inclusion
• Patient not able to meet treatment sessions as deemed by the investigator
• Patient not able to complete requested investigation assessments as deemed by the investigator.