Skip to content

Neural Injury in Adolescents With Concussion

Neural Injury in Adolescents With Concussion

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03011983
Enrollment
4
Registered
2017-01-06
Start date
2017-04-11
Completion date
2018-06-01
Last updated
2018-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild Traumatic Brain Injury, Concussion, Mild, Acute Brain Injury

Keywords

Magnetoencephalography (MEG), Magnetic resonance imaging (MRI)

Brief summary

This study utilizes multimodal brain imaging to obtain quantitative biomarkers of brain injury and to improve understanding of the biological basis of brain pathology in adolescents with concussion. Adolescents with a concussion will undergo neuroimaging and neuropsychology assessments acutely and four months after injury.

Detailed description

Concussion is a highly prevalent condition in adolescence, but it remains a clinical diagnosis that largely relies on subjective patient report with no reliable objective biomarkers for diagnosis. Traditional clinical brain imaging has not been found useful for concussion as the pathology is generally not visible on conventional acute MRI or CT. The proposed study addresses this gap in concussion diagnosis and management by examining the sensitivity of magnetoencephalography (MEG) for identifying areas of brain injury through detection of abnormal neural activity (slowing) in adolescents with concussion compared to healthy controls. Adolescents with a concussion will complete neuroimaging (MEG and MRI) and neuropsychology assessments at two time points within ten days and then again 4 months post-injury. Healthy controls will complete neuroimaging and neuropsychology assessments at a single time point.

Interventions

DEVICEMEG

MEG is a non-invasive functional imaging technique that can measure slow-wave neural activity.

DEVICEMRI

MRI is a non-invasive imaging modality that provides measures of brain structure.

A battery of tests will be administered by a neuropsychologist to evaluate the cognitive function of adolescents with concussion compared to healthy controls.

Sponsors

Children's Hospital of Philadelphia
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
Yes

Inclusion criteria

* Diagnosis of concussion and within 2 weeks of injury (case subjects) * No history of diagnosed concussion (control subjects)

Exclusion criteria

* Head injury within 1 year of recent concussion (case subjects) * History of neurologic, psychiatric, developmental or learning disorders (all subjects)

Design outcomes

Primary

MeasureTime frameDescription
Difference in MEG Whole-Brain Slow-Wave Sensitivity between Controls and Concussion PatientsUp to 2 monthsWhole-brain, resting-state slow-wave maps of whole brain activity will be obtained from the MEG imaging in both adolescents with a concussion and healthy controls. Control images will be analyzed to determine a whole brain z-score value that includes typically developing controls below the 95th percentile, the z-score threshold for this group). Z-score images for the adolescents with concussion will be obtained and the number of adolescents with concussion above this z-score threshold will be determined, and compared to the healthy controls. The sensitivity and specificity of this method determined.

Secondary

MeasureTime frameDescription
Difference in MRI White-Matter Diffusion Measures between Controls and Concussion PatientsUp to 2 monthsMRI diffusion data will be collected to examine associations between abnormal brain slowing and white matter damage in the adolescents with a concussion versus controls. Regions showing abnormal white matter diffusion will be comparing to normative control diffusion data.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026