N/A
N=50
Pilot Clinical Investigation Evaluating the Safety and Performance of RGn550 in Treating Sportspeople Suffering From Acute Concussion Syndrome
Acute Concussion Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT05647304 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: Incidence of RGn550's Adverse Device Effects (ADEs) — 10; 10 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- RGn550 5 Hz-PWM (Device); RGn550 10 Hz-PWM (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- REGEnLIFE SAS
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of RGn550's Adverse Device Effects (ADEs) |
10; 10 | — |
| SECONDARY Incidence of RGn550's ADEs Per Severity (Mild, Moderate and Severe) |
10; 10; 0; 0; 0; 0 | — |
| SECONDARY Incidence of RGn550's Adverse Events (AEs) |
12; 10 | — |
| SECONDARY Incidence of RGn550's Device Deficiencies (DDs) |
4; 1 | — |
| SECONDARY Evolution of Automated Oculomotor and Oculopostural Functions, as Assessed Through the Convergence |
4.6; 2.9; 1.8; 0.4; 1.3; 0.3 | — |
| SECONDARY Evolution of Automated Oculomotor and Oculopostural Functions, as Assessed Through Deviations |
18; 17; 11; 13; 12; 11 | — |
| SECONDARY Evolution of Automated Oculomotor and Oculopostural Functions, as Assessed Through Deviations |
18; 17; 11; 13; 12; 11 | — |
| SECONDARY Evolution of the Balance Function, as Assessed Through Static Stabilometric Parameters |
6.5; 6.3; 6.9; 6.3; 5.7; 7.5 | — |
| SECONDARY Evolution of the Balance Function, as Assessed Through Static Stabilometric Parameters |
6.5; 6.3; 6.9; 6.3; 5.7; 7.5 | — |
| SECONDARY Evolution of Executive Function, as Assessed With the Trail Making Test Part A and B (TMT A&B) |
19.0; 21.2; 15.7; 18.5; 53.5; 50.9 | — |
| SECONDARY Evolution of Concussion Syndrome Symptoms |
0.4; 0.3; 4.6; 5.5; 1.2; 1.7 | — |
| SECONDARY Evolution of the Concussion Blood Markers |
95.3; 82.5; 67.7; 49.8; 11.0; 3.9 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT05647304). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.