By InvitationNot Applicable

Positive Assurance and mTBI

United States229 participantsStarted 2021-10-15

Plain-language summary

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.

Who can participate

Age range13 Years – 21 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

Behavioral Regulation Assessment for Concussion (BRAC)

Timeframe: Gathered at Baseline Visit

Expectations of Recovery Scale

Timeframe: Gathered at Baseline Visit

Trial details

NCT IDNCT04982731

SponsorInova Health Care Services

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-10

View on ClinicalTrials.gov More MTBI - Mild Traumatic Brain Injury trials