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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02988609
Acronym
RugbyCom
Enrollment
44
Registered
2016-12-09
Start date
2016-09-30
Completion date
2022-10-10
Last updated
2024-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Concussion

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).

Interventions

DEVICEfMRI

fMRI at 3 different times after concussion: just after concussion (V1), once players have clinically recovered (V2) and 3 months after V2 (V3).

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 35 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Difference of connectivity maps between the players with concussion and the group controlup to 1 monthconnectivity maps obtained during a 10 minutes resting state fMRI at V2

Secondary

MeasureTime frameDescription
Difference of connectivity maps between the players with concussion and the group controlup to 3 monthsConnectivity maps obtained during a 10 minutes resting state fMRI at V1 and V3
neuropsychological questionnaireup to 3 monthsScores obtained the neuropsychological assessment. Memory, attention and executive functions will be assessed using validated tools.
neurophysiological dataup to 3 monthsStructural imaging data (DTI)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026