Impact of Sports-related Concussions on the Attention and Executive Skills of Adolescents and Young Adults: Links With Subjective Symptoms and Recovery

Sports-related Concussion Clinical Trial

— EXAECOS  

Official title:

Impact of Sports-related Concussions on the Attention and Executive Skills of Adolescents and Young Adults: Links With Subjective Symptoms and Recovery.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03914833
• Other study ID #: BEJOT 2018-2
• Status: Completed
• Start date: March 28, 2019
• Est. completion date: March 10, 2020

Study information

• Verified date: November 2021
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: March 10, 2020
• Est. primary completion date: March 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 25 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Person subject to legal protection (curatorship, guardianship)

• Person subject to limited judicial protection

• Pregnant, parturient or breastfeeding woman

• Major unable to consent

• For controls: subjects with a history of learning disabilities and/or concussion (identification of this history on the SCAT3 inclusion questionnaire).

Related Conditions & MeSH terms

• Sports-related Concussion

Intervention

Other:
• Inclusion Questionnaires
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)
• Questionnaires at inclusion, M1 and M3
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)

Locations

Country	Name	City	State
France	CHU Dijon Bourgogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reaction time on the TAP computerized battery		Through study completion, an average of 23 month
Primary	Number of errors on the TAP computerized battery		Through study completion, an average of 23 month