Pilot Clinical Investigation Evaluating the Safety and Performance of RGn550 in Treating Sportspeople Suffering From Acute Concussion Syndrome

NCT05647304 | Completed Results

• 2 other identifiers: RGnCON2022-A01319-34
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Concussion Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (11)

• Incidence of RGn550's ADEs Per Severity (Mild, Moderate and Severe)

  Throughout the investigation (from Day 0 to Day 52)

• Incidence of RGn550's Adverse Events (AEs)

  Throughout the investigation (from Day 0 to Day 52)

• Incidence of RGn550's Device Deficiencies (DDs)

  Throughout the investigation (from Day 0 to Day 52)

• 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 Automated Oculomotor and Oculopostural Functions, as Assessed Through Deviations

  at Day 0 and Day 7 (before and after treatment session) and at Day 52

Study Arms (2)

5 Hz-PWM

OTHER

RGn550 with a 5 Hz-pulsed wave mode light emission

Device: RGn550 5 Hz-PWM

10 Hz-PWM

OTHER

RGn550 with a 10 Hz-pulsed wave mode light emission

Device: RGn550 10 Hz-PWM

Interventions

RGn550 5 Hz-PWM DEVICE

RGn550 with a 5 Hz-pulsed wave mode light emission

5 Hz-PWM

RGn550 10 Hz-PWM DEVICE

RGn550 with a 10 Hz-pulsed wave mode light emission

10 Hz-PWM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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")
• 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 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 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

Sponsors & Collaborators

• REGEnLIFE SAS: lead
• RCTs: collaborator
• University Hospital, Montpellier: collaborator

Study Sites (1)

Hôpital Européen Georges Pompidou

Paris, 75015, France

Location

MeSH Terms

Conditions

Brain Concussion; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Limitations and Caveats

Lack of sham group Single blinding Monocentric design

Results Point of Contact

• Title: Guillaume Blivet
• Organization: REGEnLIFE

gblivet@regenlife.com

+33434481535

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: November 22, 2022
• First Posted: December 12, 2022
• Study Start: October 11, 2022
• Primary Completion: June 20, 2023
• Study Completion: June 20, 2023
• Last Updated: March 10, 2025
• Results First Posted: December 5, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)