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

Toulouse University Hospital

Status: Terminated

Conditions: Concussion

Treatments: Device: fMRI

Study type: Interventional

Funder types: Other

Identifiers

NCT02988609

RC31/15/7730

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 44 patients

Sex: Male

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

Concussion Group

Experimental group

Description:

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.

Treatment:

Device: fMRI

Control Group

Active Comparator group

Description:

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.

Treatment:

Device: fMRI