Longitudinal Study of Children With Concussions

NCT03415048 | Completed

• 1 other identifier: IRB2014-15813
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Conditions

Concussions

Outcome Measures

Primary Outcomes (1)

• 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.

  3 years

Interventions

No Intervention OTHER

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead

Study Sites (1)

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

Study Officials

• Cynthia LaBella

  Ann & Robert H Lurie Children's Hospital of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: January 26, 2016
• First Posted: January 30, 2018
• Study Start: September 1, 2014
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: November 15, 2024

Record last verified: 2024-11

Locations

US (1)