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]

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05647304

Acronym

RECOVERY

Enrollment

Registered

2022-12-12

Start date

2022-10-11

Completion date

2023-06-20

Last updated

2025-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Concussion Syndrome

Keywords

Concussion, mTBI, Neurostimulation, Optics and photonics, Photobiomodulation, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Medical Device

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.

Interventions

DEVICERGn550 5 Hz-PWM

RGn550 with a 5 Hz-pulsed wave mode light emission

DEVICERGn550 10 Hz-PWM

RGn550 with a 10 Hz-pulsed wave mode light emission

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Intervention model description

An interventional, prospective, monocentric, randomized, comparative and simple-blinded pilot clinical investigation

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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 Deviations	at Day 0 and Day 7 (before and after treatment session) and at Day 52	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).
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 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 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 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
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 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.

Countries

France

Participant flow

Recruitment details

Recruitment period : 11 October 2022 - 02 May 2023 One site located in France

Participants by arm

Arm	Count
5 Hz-PWM RGn550 with a 5 Hz-pulsed wave mode light emission RGn550 5 Hz-PWM: RGn550 with a 5 Hz-pulsed wave mode light emission	26
10 Hz-PWM RGn550 with a 10 Hz-pulsed wave mode light emission RGn550 10 Hz-PWM: RGn550 with a 10 Hz-pulsed wave mode light emission	24
Total	50

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Withdrawal by Subject	1	0

Baseline characteristics

Characteristic	5 Hz-PWM	10 Hz-PWM	Total
Age, Continuous	24.9 years STANDARD_DEVIATION 5.2	25.1 years STANDARD_DEVIATION 5.1	25.0 years STANDARD_DEVIATION 5.1
Concussion history	2.0 concussion STANDARD_DEVIATION 2.1	1.4 concussion STANDARD_DEVIATION 1.6	1.7 concussion STANDARD_DEVIATION 1.9
Race and Ethnicity Not Collected	—	—	0 Participants
Region of Enrollment France	26 participants	24 participants	50 participants
Sex: Female, Male Female	3 Participants	3 Participants	6 Participants
Sex: Female, Male Male	23 Participants	21 Participants	44 Participants
Time between concussion and inclusion	2.4 days STANDARD_DEVIATION 0.5	2.3 days STANDARD_DEVIATION 0.4	2.3 days STANDARD_DEVIATION 0.5

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 26	0 / 24
other Total, other adverse events	12 / 26	10 / 24
serious Total, serious adverse events	0 / 26	0 / 24

Outcome results

Primary