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]
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Incidence of RGn550's Adverse Device Effects (ADEs)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- 未提供
结局指标
主要结局
Incidence of RGn550's Adverse Device Effects (ADEs)
时间窗: Throughout the investigation (from Day 0 to Day 52)
Percentage of patients with at least one ADE
次要结局
- 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 Concussion Syndrome Symptoms(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 Executive Function, as Assessed With the Trail Making Test Part A and B (TMT A&B)(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 the Concussion Blood Markers(at Day 0 (before 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)
- Evolution of the Balance Function, as Assessed Through Static Stabilometric Parameters(at Day 0 and Day 7 (before and after treatment session) and at Day 52)