Longitudinal Study of Children With Concussions

Concussions Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03415048
• Other study ID #: IRB2014-15813
• Status: Recruiting
• Phase: N/A
• First received: January 26, 2016
• Last updated: January 23, 2018
• Start date: September 2014
• Est. completion date: May 2019

Study information

• Verified date: January 2018
• Source: Ann & Robert H Lurie Children's Hospital of Chicago
• Contact: Jamie Burgess
• Phone: 312-227-6531
• Email: jburgess[@]luriechildrens.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: May 2019
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Concussions

Intervention

Other:
• No Intervention

Locations

Country	Name	City	State
United States	Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Ann & Robert H Lurie Children's Hospital of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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