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

NCT ID: NCT03914833

Last Updated: 2021-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

72 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-28

Study Completion Date

2020-03-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sports-related Concussion

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients

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

Questionnaires at inclusion, M1 and M3

Intervention Type OTHER

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)

Control - High-level athelete

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

Inclusion Questionnaires

Intervention Type OTHER

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 - Non-high-level athelete

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

Inclusion Questionnaires

Intervention Type OTHER

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)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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)

Intervention Type OTHER

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)

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).
Minimum Eligible Age

13 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHU Dijon Bourgogne

Dijon, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BEJOT 2018-2

Identifier Type: -

Identifier Source: org_study_id