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

Not Applicable

Completed

Conditions: Acute Concussion Syndrome

Interventions: Device: RGn550 5 Hz-PWM
Device: RGn550 10 Hz-PWM

Registration Number: NCT05647304

Lead Sponsor: REGEnLIFE SAS

Brief 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 50

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.

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
5 Hz-PWM	RGn550 5 Hz-PWM	RGn550 with a 5 Hz-pulsed wave mode light emission
10 Hz-PWM	RGn550 10 Hz-PWM	RGn550 with a 10 Hz-pulsed wave mode light emission

Primary Outcome Measures

Name	Time	Method
Incidence of RGn550's Adverse Device Effects (ADEs)	Throughout the investigation (from Day 0 to Day 52)	Percentage of patients with at least one ADE

Secondary Outcome Measures

Name	Time	Method
Incidence of RGn550's ADEs Per Severity (Mild, Moderate and Severe)	Throughout the investigation (from Day 0 to Day 52)	Percentage of patients with at least one ADE per severity (mild, moderate and severe)
Incidence of RGn550's Adverse Events (AEs)	Throughout the investigation (from Day 0 to Day 52)	Percentage of patients with at least one AE
Incidence of RGn550's Device Deficiencies (DDs)	Throughout the investigation (from Day 0 to Day 52)	Percentage of patients with at least one DD
Evolution of Automated Oculomotor and Oculopostural Functions, as Assessed Through the Convergence	at Day 0 and Day 7 (before and after treatment session) and at Day 52	Evolution of the Near Point of Convergence (NPC)
Evolution of Automated Oculomotor and Oculopostural Functions, as Assessed Through Deviations	at Day 0 and Day 7 (before and after treatment session) and at Day 52	Evolution of the deviations assessed via Maddox rod test (horizontal deviation, vertical deviation of at least one eye)
Evolution of the Balance Function, as Assessed Through Static Stabilometric Parameters	at Day 0 and Day 7 (before and after treatment session) and at Day 52	Evolution of the difference between left and right distributions of patient's body weight Patient's body weight left distribution, respectively right distribution, refer to patient's body weight distribution on his/her left foot, respectively right foot. The left distribution and the right distribution are two percentages which sum makes 100%. When body weight is well distributed between left and right feet (coherent balance), the difference between left and right distributions is ≤ 5%. When body weight is not well distributed between left and right feet (uncoherent balance), the difference between left and right distributions is \> 5%. These distributions were measured using the stabilometric platform KFORCE Plates on which the patients were asked to stand for 30 s with closed eyes.
Evolution of Concussion Syndrome Symptoms	at baseline (which represents the patient's state before the concussion as estimated/assessed by the patient on D0), Day 0 (before treatment session), Day 7 (before treatment session), Day 14 and Day 52	Evolution of the SCAT5 (Sport Concussion Assessment Tool - 5th edition) score The SCAT5 is a standardized tool for evaluating concussions designed for use by physicians and licensed healthcare professionals. With this tool, the patient rates the intensity of every symptom from 0 (none) to 6 (severe) using a form. This enables to calculate the total number of symptoms (subscore from 0 to 22) and the symptom severity score (subscore from 0 to 132).
Evolution of Executive Function, as Assessed With the Trail Making Test Part A and B (TMT A&B)	at Day 0 (before treatment session) and at Day 7 (after treatment session) Of note: for 46 patients, TMTB was performed before (rather than after) treatment at D7 (deviation)	Evolution of the Trail Making Test part A and B (TMT A\&B) time to perform the task
Evolution of the Concussion Blood Markers	at Day 0 (before treatment session) and at Day 52	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) Of note: IL-11 and IL-13 could eventually not be analyzed due to undetectable low concentrations