Positive Assurance and mTBI (NCT04982731) | Clinical Trial Compass
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 range
13 Years – 21 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is only enrolling by invitation — can you tell me whether I might be eligible to be referred or invited, and who controls that decision?
2The study is measuring something called the 'Behavioral Regulation Assessment for Concussion' and 'Expectations of Recovery Scale' — what do those tools actually assess, and what will participating require me to do in terms of tests or questionnaires?
3Since this trial is listed as 'Phase NA,' it seems more like a behavioral or observational study than a drug trial — can you explain what type of intervention or approach is being tested here, and what the actual experience of being in the study would look like for me day-to-day?
4The study focuses on 'positive assurance' after a mild TBI or concussion — does the evidence behind this approach suggest it could genuinely change how I recover, and how does it compare to the standard care I'd receive if I didn't participate?
5Given that I'm recovering from a mild TBI, are there any aspects of participating in this study — like the time commitment, travel, or repeated assessments — that could interfere with my recovery or my current treatment plan?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Behavioral Regulation Assessment for Concussion (BRAC)