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

NCT02988609 | Terminated

• 1 other identifier: RC31/15/7730
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Concussion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Difference of connectivity maps between the players with concussion and the group control

  up to 3 months

• neuropsychological questionnaire

  up to 3 months

• neurophysiological data

  up to 3 months

Study Arms (2)

Concussion Group

EXPERIMENTAL

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

Control Group

ACTIVE COMPARATOR

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

Interventions

fMRI DEVICE

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

Concussion Group; Control Group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• no neurological or psychiatric disease
• recent history of concussion (\<3 months) according to the Rugby French Federation criteria.

You may not qualify if:

• Inability to be assessed by MRI

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

University Hospital

Toulouse, 31059, France

Location

Related Publications (1)

• 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.

  PMID: 20924757 BACKGROUND

MeSH Terms

Conditions

Brain Concussion

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• David BRAUGE, MD

  U H Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2016
• First Posted: December 9, 2016
• Study Start: September 1, 2016
• Primary Completion: August 1, 2022
• Study Completion: October 10, 2022
• Last Updated: January 3, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)