Traumatic Brain Injury
Conditions
Keywords
mTBI, Mild Traumatic Brain Injury, Axonal Injury
Brief summary
To measure Axonal Injury in children with mild traumatic brain injury enrolled in an Emergency Department using Diffusion Tensor Imaging, a type of MRI and biomarkers.
Detailed description
Objective: To determine if children with mild traumatic brain injury (mTBI) have acute axonal injury defined by disruption of diffusion of water in white matter using diffusion tensor imaging (DTI) as compared to orthopedic injury (OI) controls. Methods: Children ages 11-16 years who presented within 6 hours of either a mTBI or an isolated OI were recruited from the emergency department (ED). Patients had Diffusion Tensor Imaging (DTI) study performed within 96 hours of injury. Voxel based analysis approach was used to quantify the group differences for common DTI measures. In the ED and at the time of the scan, symptom burden was measured using the post concussion symptom scale.
Interventions
None listed
Sponsors
Children's Hospital Medical Center, Cincinnati
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
11 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
mTBI group: Inclusion: Children between the ages of \>11 to \< 16 years who present within 6 hours of injury with a witnessed head injury. A patient may have a self-reported injury to the head but there must also be evidence of head trauma on exam to be eligible for the study. Subjects must meet the clinical definition of mTBI from the American Congress of Rehabilitation Medicine122: A blow to the head or acceleration/deceleration movement of the head resulting in one or more of the following: i. loss of consciousness \<30 minutes, ii. amnesia \<24 hours, iii. any alteration in mental state at the time of the injury. Subjects without witnessed LOC/amnesia but with demonstrable amnesia in the ED are eligible. Subject must have GCS of 13-15 at the time of arrival in the ED. Subject may be enrolled prior to CT (if completed). Subjects should only have up to 1 other minor extracranial injury defined by an Abbreviated Injury Severity Scale \< 1 to that region (AIS; American Association for Automotive Medicine, 1990). Subjects will be included if they have multiple injuries that affect only 1 body system as noted in the AIS (ie, subjects who sustain skin abrasions to more than 1 body region as a result of injury but do not meet exclusion based on injury severity) Subjects and their families must be able to speak and read English. Subjects must agree to have blood drawn in the ED, and to return three times as an outpatient for repeat testing. Subjects are still eligible if they are admitted to the hospital. Subjects must have a score of less than 65 on the CBCL to be included in the study to limit possible co-morbidities. Children with a diagnosis of Attention Deficit / Hyperactivity Disorder (ADHD) will be included as long as they meet the following criteria: physician diagnosed, controlled by only one ADHD medication, and have a T-score of less than 50 on the DSM Oriented Scale for Attention Deficit / Hyperactivity Disorder (Sub-Category of CBCL). Orthopedic Injury Control Group: Subjects with isolated extremity trauma requiring radiography and an Abbreviated Injury Scale (AIS) of \< 3 (AIS; American Association for Automotive Medicine, 1990)123 will be included in the study. The presence of a fracture on the x-ray is not a requirement for inclusion. Subjects can not require immediate surgery for care. We will attempt to match based on gender and age (+/- 365 days within the included age range 11-16); yet, we will enroll consecutive eligible patients meeting inclusion/
Exclusion criteria
.Subjects must not have any evidence of head trauma / facial trauma or symptoms of concussion (such as LOC, amnesia, confusion). This information must be corroborated with a reliable witness or the parent and the treating physician. Subjects must have normal neurologic exams and must not require a head CT as a part of the clinical care. Subjects may be prescribed narcotics and/or opiates prescribed for pain in the ED will be allowed IF the subject agrees to refrain from taking the medication for at least 4 hours prior to completing the neurobehavioral testing at follow-up. Subjects must meet the same CBCL score and ADHD definition as listed in the mTBI group.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Differences in mean FA | 72 hours post enrollment | The primary analysis was to test for significant differences in mean Fractional Anisotropy in the Corpus Callosum between the mild traumatic brain injured patients and orthopedic controls. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Outcomes following mTBI | 1 week and 1 month post injury | Four meausres were used to assess functional outcomes following mTBI. These were completed at 1 week and 1 month post injury. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Biomarkers | 6 hours post injury | Participants with mTBI and OI had blood drawn up to 6 hours post injury to analyze the differences in serum proteomes to identify known and novel biomarkers of axonal injury associated with mild traumatic brain injury in children. |
Countries
United States
Outcome results
None listed