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

Not Applicable

Terminated

• Conditions: Concussion
• Interventions: Device: fMRI

• Registration Number: NCT02988609
• Lead Sponsor: University Hospital, Toulouse

Brief Summary

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

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).

Study Timeline

• Study First Submitted: 2016-05-13
• Study Start: 2016-09
• Study First Submitted QC: 2016-12-08
• Study First Posted: 2016-12-09
• Primary Completion: 2022-08
• Study Completion: 2022-10-10
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-02
• Last Update Posted: 2024-01-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Concussion Group	fMRI	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.
Control Group	fMRI	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.

Primary Outcome Measures

Name	Time	Method
Difference of connectivity maps between the players with concussion and the group control	up to 1 month	connectivity maps obtained during a 10 minutes resting state fMRI at V2

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital; 🇫🇷 Toulouse, France