Longitudinal Study of Children With Concussions

Longitudinal Study of Children With Concussions: 3-year Follow-up of Cognitive and Emotional Function, Return to Sports, and Risk of Re-injury

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

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

Study Overview

• Status: Unknown
• Conditions: Concussions
• Intervention / Treatment: Other: No Intervention

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

• Study Contact: Name: Jamie Burgess; Phone Number: 312-227-6531; Email: jburgess@luriechildrens.org

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Ann & Robert H. Lurie Children's Hospital of Chicago
      • Contact: Cynthia LaBella, MD; Phone Number: 312-227-4000
      • Principal Investigator: Cynthia LaBella, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
• Investigators: Principal Investigator: Cynthia LaBella, Ann & Robert H Lurie Children's Hospital of Chicago

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Anticipated): September 1, 2018
• Study Completion (Anticipated): May 1, 2019

Study Registration Dates

• First Submitted: January 26, 2016
• First Submitted That Met QC Criteria: January 23, 2018
• First Posted (Actual): January 30, 2018

Study Record Updates

• Last Update Posted (Actual): January 30, 2018
• Last Update Submitted That Met QC Criteria: January 23, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: IRB2014-15813