Neural Injury in Adolescents With Concussion

Completed

• Conditions: Mild Traumatic Brain Injury; Acute Brain Injury; Concussion, Mild
• Interventions: Device: MEG; Device: MRI; Behavioral: Neuropsychology assessment

• Registration Number: NCT03011983
• Lead Sponsor: Children's Hospital of Philadelphia

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.

Study Timeline

• Study First Submitted: 2016-12-29
• Study First Submitted QC: 2017-01-04
• Study First Posted: 2017-01-06
• Study Start: 2017-04-11
• Primary Completion: 2018-06-01
• Study Completion: 2018-06-01
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-23
• Last Update Posted: 2018-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adolescents With Concussion	MEG	Adolescents with a concussion (n=120) will undergo neuroimaging (MEG and MRI) and neuropsychology assessments at two time points in the acute and chronic periods after injury, respectively. Brain imaging injury measures will be compared to a control normative database we will create. These brain measures will also be associated with cognitive and clinical outcomes.
Adolescents With Concussion	Neuropsychology assessment	Adolescents with a concussion (n=120) will undergo neuroimaging (MEG and MRI) and neuropsychology assessments at two time points in the acute and chronic periods after injury, respectively. Brain imaging injury measures will be compared to a control normative database we will create. These brain measures will also be associated with cognitive and clinical outcomes.
Adolescents Without Concussion	MRI	Age- and gender-matched healthy controls (n=160) will be recruited to establish a normative database of whole-brain slow-wave maps from MEG resting-state data as well as white-matter diffusion measures from MRI.
Adolescents With Concussion	MRI	Adolescents with a concussion (n=120) will undergo neuroimaging (MEG and MRI) and neuropsychology assessments at two time points in the acute and chronic periods after injury, respectively. Brain imaging injury measures will be compared to a control normative database we will create. These brain measures will also be associated with cognitive and clinical outcomes.
Adolescents Without Concussion	MEG	Age- and gender-matched healthy controls (n=160) will be recruited to establish a normative database of whole-brain slow-wave maps from MEG resting-state data as well as white-matter diffusion measures from MRI.
Adolescents Without Concussion	Neuropsychology assessment	Age- and gender-matched healthy controls (n=160) will be recruited to establish a normative database of whole-brain slow-wave maps from MEG resting-state data as well as white-matter diffusion measures from MRI.

Primary Outcome Measures

Name	Time	Method
Difference in MEG Whole-Brain Slow-Wave Sensitivity between Controls and Concussion Patients	Up to 2 months	Whole-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 Outcome Measures

Name	Time	Method
Difference in MRI White-Matter Diffusion Measures between Controls and Concussion Patients	Up to 2 months	MRI 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.

Trial Locations

Locations (1)

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States