New treatment option for Traumatic Chronic Encephalopathy
Official title Cerebral and Cognitive Impact of Professional Soccer Practice
ClinicalTrials.gov ID: NCT04903015
What this study is testing
- What it's testing
- The objective of this study is to evaluate, using MRI, the microstructural consequences and the onset of any cognitive impairment in professional soccer players at the end of their career, who have experienced repeated minor head injuries. Over the long term, these head injuries could lead to morphological lesions and have an impact on soccer players' cognitive skills.
- Time commitment: about 10 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 32 to 55, men only. Healthy volunteers may be eligible.
You may be able to join if
- Exposed high-level athletes: professional soccer players at the end of their career (32- years old) playing in France Ligue 1 or 2 exposed to...
- -High-level athletes not exposed to repeated mild head injuries: control group paired for age with professional soccer players, who have never...
You likely can't join if
- Refusal to participate in the study;
- refusal to be informed of abnormalities on MRI
- Incapacity to give informed consent or under a legal protection order;
- History of cerebral concussion including the presence after head shock of one or more of the following signs or symptoms: a period of confusion or...
- History of severe head/brain injury;
- History of neurological or psychiatric disorder;
See the full eligibility criteria
- Exposed high-level athletes: professional soccer players at the end of their career (32- years old) playing in France Ligue 1 or 2 exposed to repeated mild head injuries with no history of severe head injury or cerebral...
- -High-level athletes not exposed to repeated mild head injuries: control group paired for age with professional soccer players, who have never regularly participated in sports exposing them to head injuries (notably...
- Refusal to participate in the study;
- refusal to be informed of abnormalities on MRI
- Incapacity to give informed consent or under a legal protection order;
- History of cerebral concussion including the presence after head shock of one or more of the following signs or symptoms: a period of confusion or disorientation, a period of loss of consciousness of 30 minutes or less...
- History of severe head/brain injury;
- History of neurological or psychiatric disorder;
- Known cerebral abnormality diagnosed by an imaging exam (CT or MRI);
- History or regular or occasional consumption of drugs, unweaned active smoking or weaned for less than 1 year, excessive consumption of alcohol (\> 20 g alcohol per day, evaluated with the formula "degree of alcohol ×...
- Usage of medication targeting the central nervous system in the 2 weeks preceding inclusion in the study;
- Prior history of severe hypertension, diabetes, chronic heart disease, progressive or disabling disease;
- Contraindication to MRI (claustrophobia, implanted material not compatible with MRI, refusal to be informed of abnormality discovered on MRI);
The study team makes the final eligibility decision.
Where it's taking place
- Strasbourg, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 10 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling male, 32 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Strasbourg, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.