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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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]

Conditions
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Acute Concussion Syndrome

Intervention / Treatment
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* Device: RGn550 5 Hz-PWM
* Device: RGn550 10 Hz-PWM


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: An interventional, prospective, monocentric, randomized, comparative and simple-blinded pilot clinical investigation
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 5 Hz-PWM<br>RGn550 with a 5 Hz-pulsed wave mode light emission | Device: RGn550 5 Hz-PWM<br>* RGn550 with a 5 Hz-pulsed wave mode light emission<br>|
| Other: 10 Hz-PWM<br>RGn550 with a 10 Hz-pulsed wave mode light emission | Device: RGn550 10 Hz-PWM<br>* RGn550 with a 10 Hz-pulsed wave mode light emission<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of RGn550's adverse device effects (ADEs) | Proportion of subjects with at least one ADE, by treatment groups and overall. | Throughout the investigation (from Day 0 to Day 52) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of RGn550's ADEs per severity (mild, moderate and severe) |  | Throughout the investigation (from Day 0 to Day 52) | 
| Incidence of RGn550's adverse events (AEs) |  | Throughout the investigation (from Day 0 to Day 52) | 
| Incidence of RGn550's device deficiencies (DDs) |  | Throughout the investigation (from Day 0 to Day 52) | 
| Evolution of automated oculomotor and oculopostural functions , as assessed through the Convergence | Evolution of the Near Point of Convergence (NPC) | at Day 0 and Day 7 (before and after treatment session) and at Day 52 | 
| Evolution of automated oculomotor and oculopostural functions, as assessed through deviations | Evolution of the deviations assessed via the Cover test | at Day 0 and Day 7 (before and after treatment session) and at Day 52 | 
| Evolution of automated oculomotor and oculopostural functions, as assessed through deviations | Evolution of the deviations assessed via Maddox rod test | at Day 0 and Day 7 (before and after treatment session) and at Day 52 | 
| Evolution of the balance function, as assessed through static stabilometric parameters | Evolution of Statokinesigram area | at Day 0 and Day 7 (before and after treatment session) and at Day 52 | 
| Evolution of the balance function, as assessed through static stabilometric parameters | Evolution of Left/right distribution | at Day 0 and Day 7 (before and after treatment session) and at Day 52 | 
| Evolution of executive function, as assessed with the Trail Making Test part A and B (TMT A&B) | Evolution of the Trail Making Test part A and B (TMT A&B) score. | at Day 0 (before treatment session) and at Day 7 (after treatment session) | 
| Evolution of concussion syndrome symptoms | Evolution of the SCAT5 (Sport Concussion Assessment Tool - 5th edition) score | at Day 0 (before treatment session), Day 7 (before treatment session), Day 14 and Day 52 | 
| Evolution of the concussion blood markers | Evolution of the concentration of: Anti-inflammatory cytokines InterLeukin (IL)-1 receptor antagonist, IL-4, IL-6, IL-10, IL-11 and IL-13 S100 calcium binding protein B (S100B) Glial Fibrillary Acidic Protein (GFAP) Ubiquitin C-terminal Hydrolase-L1 (UCH-L1) | at Day 0 (before treatment session) and at Day 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Concussion, mTBI, Neurostimulation, Optics and photonics, Photobiomodulation, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Medical Device