Clinical trial NCT05647304: Pilot Clinical Investigation Evaluating the Safety and Performance of RGn550 in Treating Sportspeople Suffering From Acute Concussion Syndrome
Official title: 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]
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Concussion Syndrome
Keywords: Concussion
mTBI
Neurostimulation
Optics and photonics
Photobiomodulation
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Medical Device
Lead sponsor: REGEnLIFE SAS
Sponsor class: INDUSTRY
Collaborators: name: RCTs
name: University Hospital, Montpellier
First posted: 2022-12-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: An interventional, prospective, monocentric, randomized, comparative and simple-blinded pilot clinical investigation
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of RGn550's Adverse Device Effects (ADEs)
timeFrame: Throughout the investigation (from Day 0 to Day 52)
Secondary outcomes:
measure: Incidence of RGn550's ADEs Per Severity (Mild, Moderate and Severe)
timeFrame: Throughout the investigation (from Day 0 to Day 52)
measure: Incidence of RGn550's Adverse Events (AEs)
timeFrame: Throughout the investigation (from Day 0 to Day 52)
measure: Incidence of RGn550's Device Deficiencies (DDs)
timeFrame: Throughout the investigation (from Day 0 to Day 52)
measure: Evolution of Automated Oculomotor and Oculopostural Functions, as Assessed Through the Convergence
timeFrame: at Day 0 and Day 7 (before and after treatment session) and at Day 52
measure: Evolution of Automated Oculomotor and Oculopostural Functions, as Assessed Through Deviations
timeFrame: at Day 0 and Day 7 (before and after treatment session) and at Day 52
measure: Evolution of Automated Oculomotor and Oculopostural Functions, as Assessed Through Deviations
timeFrame: at Day 0 and Day 7 (before and after treatment session) and at Day 52
measure: Evolution of the Balance Function, as Assessed Through Static Stabilometric Parameters
timeFrame: at Day 0 and Day 7 (before and after treatment session) and at Day 52
measure: Evolution of the Balance Function, as Assessed Through Static Stabilometric Parameters
timeFrame: at Day 0 and Day 7 (before and after treatment session) and at Day 52
measure: Evolution of Executive Function, as Assessed With the Trail Making Test Part A and B (TMT A&B)
timeFrame: 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)
measure: Evolution of Concussion Syndrome Symptoms
timeFrame: 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
measure: Evolution of the Concussion Blood Markers
timeFrame: at Day 0 (before treatment session) and at Day 52
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
Study officials:
References: