ConcussionsNCT03415048
Longitudinal Study of Children With Concussions
An observational study of Concussions, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Concussions
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Sep 2021
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children Ages 8-17 who present to one of the Lurie Sports Medicine clinics for care of a concussion.
Who may be able to join
- 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
Who cannot join
- Patients outside of the 8-17 years old age range
- Patients who show structural abnormalities on neuroimaging.
- Non-English speaking patients
Trial locations and contacts
1 site in 1 country.
United States1 site
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
About this study
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
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
- Concussions
- Being tested
- No Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2018
- Study startSep 2014
- Primary completionSep 2021
- Study completionSep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConcussionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cynthia LaBella, Ann & Robert H Lurie Children's Hospital of Chicago
- Investigators
- Cynthia LaBella, Principal investigator, Ann & Robert H Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03415048
- Sponsor's protocol ID
- IRB2014-15813
- Status last verified
- Nov 2024
- First submitted
- 26 Jan 2016
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03415048
- Acronym / sponsor ID
- IRB2014-15813
- Conditions
- Concussions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Study start
- Sep 2014 (actual)
- Primary completion
- Sep 2021 (actual)
- Study completion
- Sep 2021 (actual)
- First posted
- 30 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children Ages 8-17 who present to one of the Lurie Sports Medicine clinics for care of a concussion.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Patients outside of the 8-17 years old age range
- Patients who show structural abnormalities on neuroimaging.
- Non-English speaking patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Intervention | Other | – |
Primary outcome
Long-Term Effects of Concussion
Time frame: 3 years
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cynthia LaBella principal investigator
Ann & Robert H Lurie Children's Hospital of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Concussions, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long-Term Effects of Concussion (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2024.