Positive Assurance and mTBI

Enrolling by invitation · Not applicable

Conditions studied: MTBI - Mild Traumatic Brain Injury, Concussion, Mild Traumatic Brain Injury

In brief

This study will develop and validate a new educational video that provides positive assurance about mild traumatic brain injury (mTBI) recovery for patients with mTBI.

Key facts

Study ID

NCT04982731

Run by

Inova Health Care Services

People needed

229

Starts

2021-10-15

Expected to finish

2026-10-01

Last updated by the study team

2025-10-14

Who can join

Age: 13 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must meet the following criteria in order to be eligible to participate:
• 13-21 years
• Has sustained an external force to head or body resulting in neurological symptoms and at least one reported symptom is attributed to the mTBI (e.g., dizziness, confusion, headache, postural instability, light/noise sensitivity, nausea)
• Has receive a medical diagnosis of mTBI from an emergency physical at the IFH Pediatrics ED or Inova-GoHealth Urgent Care clinic within 72 hours of injury
• Is able to provide remote informed written consent (parent) and assent

You may not qualify if…

• Subjects who meet any of the following criteria will not be eligible to participate:
• Loss of consciousness > 30 minutes in conjunction with the injury
• Glasgow Coma Scale (GCS) score < 13
• Has sustained a previous mTBI within the past 6 months
• Has a neurological disorder (e.g., epilepsy)
• Has a positive finding on brain imaging (e.g., CT, MRI) that suggests a severe closed head or open injury involving any structural damage or abnormality (e.g., fracture, subdural hematoma)
• Has a previous history of neurosurgery
• Does not speak English as a primary language
• Requires admission to the hospital
• Has developmental delays
• Prisoner
• Pregnant*
• Has been previously enrolled in the study
• Members of same household will not be included as they may determine their group assignment if more than one person from same household is included and assigned to different groups.
• COHORT 2:
• INCLUSION CRITERIA:
• Subjects must meet the following criteria in order to be eligible to participate:
• 13-21 years
• Has scheduled an appointment to be evaluated at the Inova Sports Medicine Concussion Clinic for a traumatic closed head injury that has occurred within the past 30 days
• The time between study enrollment and the initial clinical visit is at least two days
• Is able to provide remote informed written consent (parent) and assent
• EXCLUSION CRITERIA:
• Subjects who meet any of the following criteria will not be eligible to participate:
• Loss of consciousness > 30 minutes in conjunction with the injury
• Glasgow Coma Scale (GCS) score < 13

Where it is running

• Inova Health System — Falls Church, Virginia, United States

Full record on ClinicalTrials.gov

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