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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-A01319-34 | Registry Identifier | IDRCB number. French competent authority : Agence Nationale de sécurité du médicament et des produits de santé (ANSM) |
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| Name | Class |
|---|---|
| RCTs | INDUSTRY |
| University Hospital, Montpellier | OTHER |
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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:
Considering previous investigations, this innovative technology could reduce brain inflammation implicated in concussion syndrome.
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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5 Hz-PWM | Other | RGn550 with a 5 Hz-pulsed wave mode light emission |
|
| 10 Hz-PWM | Other | RGn550 with a 10 Hz-pulsed wave mode light emission |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RGn550 5 Hz-PWM | Device | RGn550 with a 5 Hz-pulsed wave mode light emission |
| |
| 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) |
| 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) |
Not provided
Inclusion Criteria:
Non-inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Européen Georges Pompidou | Paris | 75015 | France |
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Recruitment period : 11 October 2022 - 02 May 2023 One site located in France
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Patients randomized and treated at least once (at the inclusion visit)
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of RGn550's Adverse Device Effects (ADEs) | Percentage of patients with at least one ADE | Patients randomized and treated at least once (at inclusion visit) | Posted | Count of Participants | Participants | Throughout the investigation (from Day 0 to Day 52) |
|
Throughout the investigation (from D0 to D52)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Photophobia | Eye disorders | MedDRA 25.0 | Non-systematic Assessment |
Lack of sham group Single blinding Monocentric design
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Guillaume Blivet | REGEnLIFE | +33434481535 | gblivet@regenlife.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 11, 2022 | Feb 27, 2025 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 3, 2023 | Feb 27, 2025 | SAP_003.pdf |
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| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
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An interventional, prospective, monocentric, randomized, comparative and simple-blinded pilot clinical investigation
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| RGn550 10 Hz-PWM |
| Device |
RGn550 with a 10 Hz-pulsed wave mode light emission |
|
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:
| at Day 0 (before treatment session) and at Day 52 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Time between concussion and inclusion | Mean | Standard Deviation | days |
|
| Concussion history | Mean | Standard Deviation | concussion |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | 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) | Patients randomized and treated at least once (at inclusion visit) | Posted | Count of Participants | Participants | Throughout the investigation (from Day 0 to Day 52) |
|
|
|
| Secondary | Incidence of RGn550's Adverse Events (AEs) | Percentage of patients with at least one AE | Patients randomized and treated at least once (at inclusion visit) | Posted | Count of Participants | Participants | Throughout the investigation (from Day 0 to Day 52) |
|
|
|
| Secondary | Incidence of RGn550's Device Deficiencies (DDs) | Percentage of patients with at least one DD | Patients randomized and treated at least once (at inclusion visit) | Posted | Count of Participants | Participants | Throughout the investigation (from Day 0 to Day 52) |
|
|
|
| Secondary | Evolution of Automated Oculomotor and Oculopostural Functions, as Assessed Through the Convergence | Evolution of the Near Point of Convergence (NPC) | Patients randomized and treated at least once (at inclusion visit) | Posted | Mean | Standard Deviation | NPC (cm) | at Day 0 and Day 7 (before and after treatment session) and at Day 52 |
|
|
|
| Secondary | 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). | Patients randomized and treated at least once (at inclusion visit) | Posted | Mean | Standard Deviation | score on a scale | at Day 0 and Day 7 (before and after treatment session) and at Day 52 |
|
|
|
| Secondary | 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) | Patients randomized and treated at least once (at inclusion visit) | Posted | Count of Participants | Participants | at Day 0 and Day 7 (before and after treatment session) and at Day 52 |
|
|
|
| Secondary | 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. | Patients randomized and treated at least once (at inclusion visit) | Posted | Mean | Standard Deviation | mm2 | at Day 0 and Day 7 (before and after treatment session) and at Day 52 |
|
|
|
| Secondary | 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. | Patients randomized and treated at least once (at inclusion visit) | Posted | Mean | Standard Deviation | % of body weight distribution difference | at Day 0 and Day 7 (before and after treatment session) and at Day 52 |
|
|
|
| Secondary | 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 | Patients randomized and treated at least once (at inclusion visit) | Posted | Mean | Standard Deviation | s | 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) |
|
|
|
| Secondary | 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). | Patients randomized and treated at least once (at inclusion visit) | Posted | Mean | Standard Deviation | score on a scale | 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 |
|
|
|
| Secondary | Evolution of the Concussion Blood Markers | Evolution of the concentration of:
| Patients randomized and treated at least once (at inclusion visit) | Posted | Mean | Standard Deviation | pg/mL | at Day 0 (before treatment session) and at Day 52 |
|
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| 12 |
| 26 |
| EG001 | 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 | 0 | 24 | 0 | 24 | 10 | 24 |
| Fatigue | General disorders | MedDRA 25.0 | Non-systematic Assessment |
|
| Medical device site discomfort | General disorders | MedDRA 25.0 | Non-systematic Assessment |
|
| Medical device site warmth | General disorders | MedDRA 25.0 | Non-systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
|
| Concussion | Injury, poisoning and procedural complications | MedDRA 25.0 | Non-systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 25.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 25.0 | Non-systematic Assessment |
|
| Hypersomnia | Nervous system disorders | MedDRA 25.0 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 25.0 | Non-systematic Assessment |
|
| Irritability | Psychiatric disorders | MedDRA 25.0 | Non-systematic Assessment |
|
If the investigators wish to publish data from this investigation (poster, abstract, article, etc.), they must first seek approval from REGEnLIFE.
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |
| Patients who had at least one severe ADE |
|
| D0 after treatment |
|
|
| D7 before treatment |
|
|
| D7 after treatment |
|
|
| D52 |
|
|
| D0 after treatment |
|
|
| D7 before treatment |
|
|
| D7 after treatment |
|
|
| D52 |
|
|
| Horizontal deviation : D0 after treatment |
|
|
| Horizontal deviation : D7 before treatment |
|
|
| Horizontal deviation : D7 after treatment |
|
|
| Horizontal deviation : D52 |
|
|
| Vertical deviation of at least one eye : D0 before treatment |
|
|
| Vertical deviation of at least one eye : D0 after treatment |
|
|
| Vertical deviation of at least one eye : D7 before treatment |
|
|
| Vertical deviation of at least one eye : D7 after treatment |
|
|
| Vertical deviation of at least one eye : D52 |
|
|
| D0 after treatment |
|
|
| D7 before treatment |
|
|
| D7 after treatment |
|
|
| D52 |
|
|
| D0 after treatment |
|
|
| D7 before treatment |
|
|
| D7 after treatment |
|
|
| D52 |
|
|
| TMTA time to perform the task: D7 |
|
|
| TMTB time to perform the task: D0 |
|
|
| TMTB time to perform the task: D7 |
|
|
| Total number of symptoms : D0 before treatment |
|
|
| Total number of symptoms : D7 before treatment |
|
|
| Total number of symptoms : D14 |
|
|
| Total number of symptoms : D52 |
|
|
| Symptom severity score: baseline |
|
|
| Symptom severity score: D0 before treatment |
|
|
| Symptom severity score: D7 before treatment |
|
|
| Symptom severity score: D14 |
|
|
| Symptom severity score: D52 |
|
|
| GFAP : D52 |
|
|
| UCHL1 : D0 before treatment |
|
|
| UCHL1 : D52 |
|
|
| IL-1RA : D0 before treatment |
|
|
| IL-1RA : D52 |
|
|
| IL-10 : D0 before treatment |
|
|
| IL-10 : D52 |
|
|
| IL-4 : D0 before treatment |
|
|
| IL-4 : D52 |
|
|
| IL-6 : D0 before treatment |
|
|
| IL-6 : D52 |
|
|
| S100B : D0 before treatment |
|
|
| S100B : D52 |
|
|