Concussion in Rugby Players: a Pilot Study of Neural Recovery Using fMRI

Study Overview
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Brief Summary
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This study assess the putative persistence of neural damage using resting state fMRI after concussion in rugby player once they have clinically recovered. The hypothesis is that despite a clinical recovery (absence of symptoms; neurological and neuropsychological examination returned to normal) connectivity map obtained using resting state fMRI are significantly different from a group of control subjects.

Detailed Description
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Resting state fMRI has shown to be a sensitive tool to assess neural damage after concussion. It seems more sensible than structural MRI including DTI. the study goal will be to assess rugby players using fMRI at 3 different times after concussion: just after concussion (V1), once players have clinically recovered (V2) and 3 months after V2 (V3). The study would specifically like to challenge clinical examination supposed to be normal at V2 to connectivity maps using resting state fMRI preformed at the same time. fMRI performed at V1 and V3 will serve as comparators (respectively very altered at V1 and back to normal at V3).

Official Title
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Concussion in Rugby Players: a Pilot Study of Neural Recovery Using Functional Magnetic Resonance Imaging (fMRI)

Conditions
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Concussion

Intervention / Treatment
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* Device: fMRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: no neurological or psychiatric disease recent history of concussion (<3 months) according to the Rugby French Federation criteria. Exclusion Criteria: Inability to be assessed by MRI

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Concussion Group<br>Players with a recent (<72 hours) history of concussion will be assessed 3 times. just after concussion, after disappearance of clinical symptoms and 3 months after the previous visit. During each visit, participant will undergo a neurological and a neuropsychological assessment and a structural and resting state fMRI. | Device: fMRI<br>* fMRI at 3 different times after concussion: just after concussion (V1), once players have clinically recovered (V2) and 3 months after V2 (V3).<br>|
| Active Comparator: Control Group<br>a control group with no history of concussion will be the comparator. Participants will be assessed 3 times. Visits will be the same for the control group and duration between visits in this group will be matched to the concussion group. During each visit, participant will undergo a neurological and a neuropsychological assessment and a structural and resting state fMRI. | Device: fMRI<br>* fMRI at 3 different times after concussion: just after concussion (V1), once players have clinically recovered (V2) and 3 months after V2 (V3).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference of connectivity maps between the players with concussion and the group control | connectivity maps obtained during a 10 minutes resting state fMRI at V2 | up to 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference of connectivity maps between the players with concussion and the group control | Connectivity maps obtained during a 10 minutes resting state fMRI at V1 and V3 | up to 3 months | 
| neuropsychological questionnaire | Scores obtained the neuropsychological assessment. Memory, attention and executive functions will be assessed using validated tools. | up to 3 months | 
| neurophysiological data | Structural imaging data (DTI) | up to 3 months |