Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 8:02 PM
Ignite Modification Date:
2025-12-24 @ 8:02 PM
NCT ID:
NCT05647304
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05647304
Study Brief:
Protocol Section:
NCT05647304