Ignite Creation Date:
2025-12-24 @ 8:02 PM
Ignite Modification Date:
2026-01-03 @ 10:30 AM
Study NCT ID:
NCT05647304
Status:
COMPLETED
Last Update Posted:
2025-03-10
First Post:
2022-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pilot Clinical Investigation Evaluating the Safety and Performance of RGn550 in Treating Sportspeople Suffering From Acute Concussion Syndrome
Sponsor:
REGEnLIFE SAS
Organization:
Study Overview
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]
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RECOVERY
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.
* 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2022-A01319-34 | REGISTRY | IDRCB number. French competent authority : Agence Nationale de sécurité du médicament et des produits de santé (ANSM) | View |