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

Concussion Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02988609
• Other study ID #: RC31/15/7730
• Status: Terminated
• Phase: N/A
• Start date: September 2016
• Est. completion date: October 10, 2022

Study information

• Verified date: January 2024
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 44
• Est. completion date: October 10, 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Concussion

Intervention

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).

Locations

Country	Name	City	State
France	University Hospital	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	neuropsychological questionnaire	Scores obtained the neuropsychological assessment. Memory, attention and executive functions will be assessed using validated tools.	up to 3 months
Secondary	neurophysiological data	Structural imaging data (DTI)	up to 3 months