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

Launched by REGENLIFE SAS · Dec 2, 2022

Keywords

ClinConnect Summary

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 ...

Gender

ALL

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.