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

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

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.

Study Overview

• Status: Terminated
• Conditions: Concussion
• Intervention / Treatment: Device: fMRI

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 Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David BRAUGE, MD; Phone Number: 33561777686; Email: brauge.d@chu-toulouse.fr

Study Locations

• France
  • Toulouse, France, 31059
    • University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Concussion Group; 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; fMRI at 3 different times after concussion: just after concussion (V1), once players have clinically recovered (V2) and 3 months after V2 (V3).
Active Comparator: Control Group; 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; fMRI at 3 different times after concussion: just after concussion (V1), once players have clinically recovered (V2) and 3 months after V2 (V3).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: David BRAUGE, MD, U H Toulouse

Publications and helpful links

General Publications

• Smits M, Houston GC, Dippel DW, Wielopolski PA, Vernooij MW, Koudstaal PJ, Hunink MG, van der Lugt A. Microstructural brain injury in post-concussion syndrome after minor head injury. Neuroradiology. 2011 Aug;53(8):553-63. doi: 10.1007/s00234-010-0774-6. Epub 2010 Oct 6.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): August 1, 2022
• Study Completion (Actual): October 10, 2022

Study Registration Dates

• First Submitted: May 13, 2016
• First Submitted That Met QC Criteria: December 8, 2016
• First Posted (Estimated): December 9, 2016

Study Record Updates

• Last Update Posted (Estimated): January 3, 2024
• Last Update Submitted That Met QC Criteria: January 2, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: RC31/15/7730

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No