NCT03914833

Brief Summary

Concussion in sports ("Sports-Related Concussion" or "SRC") are a public health issue. The management of these injuries is evolving rapidly and decisions to return to play are based on clinical judgment. It is now recognized that the assessment of cognitive function must be one of the components of the assessment, in particular, in the protocol used to decide if a patient can resume practice. The available scales include only a brief cognitive assessment but do not provide an understanding of the level of deficit treatment. The use of computerized TAP (Test of Attentionnal Performance) tests, including finer measures of reaction time and apprehending the different attention and executive components (alertnes, orientation, flexibility, inhibition, updating), would allow a better understanding of the nature of the disorder and link it to subjective symptoms, and recovery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 28, 2019

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

April 12, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 16, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2020

Completed
Last Updated

November 26, 2021

Status Verified

November 1, 2021

Enrollment Period

12 months

First QC Date

April 12, 2019

Last Update Submit

November 24, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Reaction time on the TAP computerized battery

    Through study completion, an average of 23 month

  • Number of errors on the TAP computerized battery

    Through study completion, an average of 23 month

Study Arms (3)

Patients

Patients aged 13 to 25 years old with a concussion in sports practice less than 72 hours previously

Other: Questionnaires at inclusion, M1 and M3

Control - High-level athelete

healthy subjects aged 13 to 25 years students at one of the partner institutions

Other: Inclusion Questionnaires

Control - Non-high-level athelete

healthy subjects aged 13 to 25 years students at one of the partner institutions

Other: Inclusion Questionnaires

Interventions

During the inclusion visit, neuropsychologist tests the scales: SCAT3 (Sport Concussion Assessment Test 3ème version), Trail-making test (TMT), Wechsler Adult Intelligence Scale (WAIS) TAP, HAS (Hospital Anxiety and Depression scale) ; PSQI (Pittsburg Sleep Quality Scale) ; RPQ (Rivermead Post concussion symptoms Questionnaire) ; and RHFUQ (Rivermead head injury follow-up questionnaire)

Control - High-level atheleteControl - Non-high-level athelete

During the inclusion visit, the 1-month visit and the 3-month visit; neuropsychologist grading of the scales: SCAT3 (Sport Concussion Assessment Test 3ème version), Trail-making test (TMT), Wechsler Adult Intelligence Scale (WAIS) TAP, HAS (Hospital Anxiety and Depression scale) ; PSQI (Pittsburg Sleep Quality Index) ; RPQ (Rivermead Post concussion symptoms Questionnaire) ; and RHFUQ (Rivermead head injury follow-up questionnaire)

Patients

Eligibility Criteria

Age13 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients consulting at the CMRR of the CHU Dijon Bourgogne

You may qualify if:

  • Person who has given his non-opposition
  • For minor controls: Written authorization and non-opposition from the 2 holders of parental authority beforehand.
  • For minor patients: non-opposition from the 2 holders of parental authority
  • For patients: patients aged 13 to 25 years old who have suffered a concussion in sports practice less than 72 hours previously and who consult at the CMRR of the CHU Dijon Bourgogne
  • For controls: healthy subjects aged 13 to 25 years old students in one of the partner schools (Lycée les Arcades de Dijon, Lycée Saint Joseph, Dijon; Collège Marcel Pardé, Dijon; CREPS (Centre de Ressources et d'Expertise à la Performance Sportive) who have not had a concussion.

You may not qualify if:

  • Person subject to legal protection (curatorship, guardianship)
  • Person subject to limited judicial protection
  • Pregnant, parturient or breastfeeding woman
  • Major unable to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Dijon Bourgogne

Dijon, 21079, France

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2019

First Posted

April 16, 2019

Study Start

March 28, 2019

Primary Completion

March 10, 2020

Study Completion

March 10, 2020

Last Updated

November 26, 2021

Record last verified: 2021-11

Locations