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

Sponsor
University Hospital, Toulouse (Other)
Overall Status
Recruiting
CT.gov ID
NCT02988609
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
75
Anticipated Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: fMRI
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Concussion in Rugby Players: a Pilot Study of Neural Recovery Using Functional Magnetic Resonance Imaging (fMRI)
Actual Study Start Date :
Sep 1, 2016
Actual Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

  2. neuropsychological questionnaire [up to 3 months]

    Scores obtained the neuropsychological assessment. Memory, attention and executive functions will be assessed using validated tools.

  3. neurophysiological data [up to 3 months]

    Structural imaging data (DTI)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 35 Years
Sexes Eligible for Study:
Male
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital Toulouse France 31059

Sponsors and Collaborators

  • University Hospital, Toulouse

Investigators

  • Principal Investigator: David BRAUGE, MD, U H Toulouse

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT02988609
Other Study ID Numbers:
  • RC31/15/7730
First Posted:
Dec 9, 2016
Last Update Posted:
Aug 18, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 18, 2022