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

NCT ID: NCT02988609

Last Updated: 2024-01-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2022-10-10

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).

Conditions

Concussion

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

fMRI

Intervention Type: DEVICE

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

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.

Group Type: ACTIVE_COMPARATOR

fMRI

Intervention Type: DEVICE

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

Interventions

fMRI

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David BRAUGE, MD

Role: PRINCIPAL_INVESTIGATOR

U H Toulouse

Locations

University Hospital

Toulouse, , France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 20924757 (View on PubMed)

Other Identifiers

RC31/15/7730

Identifier Type: -

Identifier Source: org_study_id