Acute Concussion SyndromeRECOVERYNCT05647304
Pilot Clinical Investigation Evaluating the Safety and Performance of RGn550 in Treating Sportspeople Suffering From Acute Concussion Syndrome
A study testing RGn550 5 Hz-PWM and RGn550 10 Hz-PWM in people with Acute Concussion Syndrome, run by REGEnLIFE SAS at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Concussion Syndrome
- What is being tested?
- RGn550 5 Hz-PWM and RGn550 10 Hz-PWM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 11 Oct 2022to 20 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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")
Show all 24Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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]
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.
Read the 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.
- Conditions
- Acute Concussion Syndrome
- Being tested
- RGn550 5 Hz-PWM, RGn550 10 Hz-PWM
- Keywords
- Concussion, mTBI, Neurostimulation, Optics and photonics, Photobiomodulation, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Medical Device
- Medical subject headings
- Brain Concussion, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RGn550 5 Hz-PWMDevice
RGn550 with a 5 Hz-pulsed wave mode light emission
RGn550 10 Hz-PWMDevice
RGn550 with a 10 Hz-pulsed wave mode light emission
| Study group | Role | What they receive |
|---|---|---|
| 5 Hz-PWM | Other | RGn550 with a 5 Hz-pulsed wave mode light emission Receives: Device: RGn550 5 Hz-PWM |
| 10 Hz-PWM | Other | RGn550 with a 10 Hz-pulsed wave mode light emission Receives: Device: RGn550 10 Hz-PWM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of RGn550's Adverse Device Effects (ADEs)
Percentage of patients with at least one ADE
Measured: Throughout the investigation (from Day 0 to Day 52)
Secondary outcomes (11)
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)
Measured: Throughout the investigation (from Day 0 to Day 52)
Incidence of RGn550's Adverse Events (AEs)
Percentage of patients with at least one AE
Measured: Throughout the investigation (from Day 0 to Day 52)
Incidence of RGn550's Device Deficiencies (DDs)
Percentage of patients with at least one DD
Measured: 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)
Measured: 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).
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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).
Measured: 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
Measured: at Day 0 (before treatment session) and at Day 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start11 Oct 2022
- Primary completion20 Jun 2023
- Study completion20 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Concussion SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- An interventional, prospective, monocentric, randomized, comparative and simple-blinded pilot clinical investigation
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- REGEnLIFE SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- RCTs, University Hospital, Montpellier
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05647304
- Sponsor's protocol ID
- RGnCON
- Other IDs
- 2022-A01319-34
- Acronym
- RECOVERY
- Status last verified
- Oct 2024
- First submitted
- 22 Nov 2022
- Last updated
- 10 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chermann JF, Malafosse P, Champleboux G, Bisiaux J, Guillemin S, Benmerad M, Varet A, Cristofini P, Blivet G, Touchon J. Brain photobiomodulation therapy for acute sport-related concussion: a randomized, single-blinded, pilot clinical trial (RECOVERY study). Front Neurol. 2026 Sep 22;17:1894623. doi: 10.3389/fneur.2026.1894623. eCollection 2026.
PubMed 42840704
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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]
- ClinicalTrials.gov ID
- NCT05647304
- Acronym / sponsor ID
- RECOVERY / RGnCON
- Conditions
- Acute Concussion Syndrome
- Keywords
- Concussion, mTBI, Neurostimulation, Optics and photonics, Photobiomodulation, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- REGEnLIFE SASIndustry (pharma, biotech, devices)
- Collaborators
- RCTs, University Hospital, Montpellier
- Study start
- 11 Oct 2022 (actual)
- Primary completion
- 20 Jun 2023 (actual)
- Study completion
- 20 Jun 2023 (actual)
- First posted
- 12 Dec 2022 (actual)
- Results
- Posted 5 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- An interventional, prospective, monocentric, randomized, comparative and simple-blinded pilot clinical investigation
| Arm | Type | Receives |
|---|---|---|
| 5 Hz-PWM | Other | Device: RGn550 5 Hz-PWMRGn550 with a 5 Hz-pulsed wave mode light emission |
| 10 Hz-PWM | Other | Device: RGn550 10 Hz-PWMRGn550 with a 10 Hz-pulsed wave mode light emission |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- 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.
- Patient protected by a French legal measure ("sauvegarde de justice", "tutelle" or "curatelle")
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RGn550 5 Hz-PWMRGn550 with a 5 Hz-pulsed wave mode light emission | Device | 5 Hz-PWM |
| RGn550 10 Hz-PWMRGn550 with a 10 Hz-pulsed wave mode light emission | Device | 10 Hz-PWM |
Primary outcome
Incidence of RGn550's Adverse Device Effects (ADEs)
Time frame: Throughout the investigation (from Day 0 to Day 52)
Percentage of patients with at least one ADE
11 secondary outcomes
Incidence of RGn550's ADEs Per Severity (Mild, Moderate and Severe)
Time frame: Throughout the investigation (from Day 0 to Day 52)
Incidence of RGn550's Adverse Events (AEs)
Time frame: Throughout the investigation (from Day 0 to Day 52)
Incidence of RGn550's Device Deficiencies (DDs)
Time frame: Throughout the investigation (from Day 0 to Day 52)
Evolution of Automated Oculomotor and Oculopostural Functions, as Assessed Through the Convergence
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: at Day 0 (before treatment session) and at Day 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42840704Chermann JF, Malafosse P, Champleboux G, Bisiaux J, Guillemin S, Benmerad M, Varet A, Cristofini P, Blivet G, Touchon J. Brain photobiomodulation therapy for acute sport-related concussion: a randomized, single-blinded, pilot clinical trial (RECOVERY study). Front Neurol. 2026 Sep 22;17:1894623. doi: 10.3389/fneur.2026.1894623. eCollection 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RGn550 5 Hz-PWM and RGn550 10 Hz-PWM in people with Acute Concussion Syndrome, run by REGEnLIFE SAS at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of RGn550's Adverse Device Effects (ADEs) (time frame: Throughout the investigation (from Day 0 to Day 52)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05647304, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025.