CompletedNCT03415048Updated Nov 15, 2024

Longitudinal Study of Children With Concussions

An observational study in Concussions, sponsored by Ann & Robert H Lurie Children's Hospital of Chicago. Completed at 1 site in United States. Open to participants aged 8 Years to 17 Years. Per ClinicalTrials.gov, last updated 2024-11-15.

Sponsored by Ann & Robert H Lurie Children's Hospital of Chicago · Observational

Study type: Observational
Model: Case-only
Time perspective: Prospective
Enrollment: 500
Ages: 8 Years to 17 Years
Sex: All

Study summary

For children and adolescents who have had a concussion resulting in prolonged symptoms (>3 months), the investigators will:

Measure post-concussion symptoms, cognitive and emotional function during the 3 years post-injury.
Determine length of recovery and frequency of return to prior level of sports participation.
Determine the incidence of and risk factors for subsequent concussion during the 3 years post-injury.

Conditions studied

Concussions

Who can participate

Ages eligible: 8 Years to 17 Years
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

Children Ages 8-17 who present to one of the Lurie Sports Medicine clinics for care of a concussion.

Inclusion criteria

Patients between the ages of 8-17 years old who present to one of the Lurie Sports Medicine clinics for care of a concussion.
English-speaking patients

Exclusion criteria

Exclusion Criteria:

Patients outside of the 8-17 years old age range
Patients who show structural abnormalities on neuroimaging.
Non-English speaking patients

Study design

Observational model: Case-only
Time perspective: Prospective
Enrollment: 500 participants (actual)
Target follow-up: 3 Years
Patient registry: Yes

Interventions

OtherNo Intervention

What researchers measure

Primary outcomes

Long-Term Effects of Concussion
All of the following measures will be aggregated using PROMIS - a computerized survey tool: what sports are played by the participant, whether or not the participant has quit a sport (due to concussion or not), development of anxiety or depression post-concussion, changes in peer relations post-concussion, change in cognitive function post-concussion, and if the participant has been subjected to a stigma after being diagnosed with a concussion.
Time frame: 3 years

Study locations

1 site

Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois 60611, United States

Registry details

Key details

Study ID: NCT03415048
Lead sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Responsible party: Cynthia LaBella (Attending Physician, Ann & Robert H Lurie Children's Hospital of Chicago) — Principal investigator
First posted: Jan 30, 2018
Start date: Sep 2014
Primary completion: Sep 2021
Completion: Sep 2021
Last update: Nov 15, 2024

Study contacts

Cynthia LaBella

principal investigator · Ann & Robert H Lurie Children's Hospital of Chicago

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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