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

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.

Study Overview

• Status: Completed
• Conditions: Acute Concussion Syndrome
• Intervention / Treatment: Device: RGn550 5 Hz-PWM; Device: RGn550 10 Hz-PWM

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75015
    • Hôpital Européen Georges Pompidou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 5 Hz-PWM; RGn550 with a 5 Hz-pulsed wave mode light emission	Device: RGn550 5 Hz-PWM; RGn550 with a 5 Hz-pulsed wave mode light emission
Other: 10 Hz-PWM; RGn550 with a 10 Hz-pulsed wave mode light emission	Device: RGn550 10 Hz-PWM; RGn550 with a 10 Hz-pulsed wave mode light emission

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of RGn550's Adverse Device Effects (ADEs)	Percentage of patients with at least one ADE	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)	Percentage of patients with at least one ADE per severity (mild, moderate and severe)	Throughout the investigation (from Day 0 to Day 52)
Incidence of RGn550's Adverse Events (AEs)	Percentage of patients with at least one AE	Throughout the investigation (from Day 0 to Day 52)
Incidence of RGn550's Device Deficiencies (DDs)	Percentage of patients with at least one DD	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 deviation assessed via the Cover test considering both eyes The unilateral cover test was used in this investigation, which consists into covering one eye, horizontally moving a target 5 cm in front of both eyes, and then uncovering the covered eye and observing its reaction. If it fixes the target, this is normal: there is an orthophoria. If it moves to fix the target (restitution movement), the test is positive: there is a heterophoria in near vision. Patients who had visual corrections were to keep them during the test. The test was then repeated on the other eye. The outcome of this test was a deviation value, considering both eyes, comprised between 0 (better outcome = normal fixation) and 3 (worst outcome = deviated eye without restitution movement).	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 (horizontal deviation, vertical deviation of at least one eye)	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 with closed eyes The statokinesigram is the projection onto a 2-dimensional space of the trajectory of the patient's center of pressure. Its area is measured in mm2. The larger the area is, the higher the patient's imbalance is. The statokinesigram area was measured using the stabilometric platform KFORCE Plates on which the patients were asked to stand for 30 s with closed eyes.	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 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.	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) time to perform the task	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 Concussion Syndrome Symptoms	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).	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 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) Of note: IL-11 and IL-13 could eventually not be analyzed due to undetectable low concentrations	at Day 0 (before treatment session) and at Day 52

Collaborators and Investigators

• Sponsor: REGEnLIFE SAS
• Collaborators: University Hospital, Montpellier; RCTs

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2022
• Primary Completion (Actual): June 20, 2023
• Study Completion (Actual): June 20, 2023

Study Registration Dates

• First Submitted: November 22, 2022
• First Submitted That Met QC Criteria: December 2, 2022
• First Posted (Actual): December 12, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 27, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: mTBI; Concussion; Nervous System Diseases; Central Nervous System Diseases; Medical Device; Photobiomodulation; Brain Diseases; Neurostimulation; Optics and photonics
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome
• Other Study ID Numbers: RGnCON; 2022-A01319-34 (Registry Identifier: IDRCB number. French competent authority : Agence Nationale de sécurité du médicament et des produits de santé (ANSM))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No