CompletedNot Applicable

SMART Concussion Trial: Symptom Management vs Alternative Randomized Treatment of Concussion Trial

Canada62 participantsStarted 2023-04-10

Plain-language summary

Given the rising rates of concussion in youth ages 10-19 and the significant proportion of young people who remain symptomatic for months following concussion, research evaluating the efficacy of multifaceted treatment options following concussion is imperative. Studies examining the efficacy of treatment strategies following concussion in children and adults are surprisingly limited, and most focus on one treatment approach, have small sample sizes, are not randomized controlled trials, and focus on individuals with prolonged recovery (months). There is a need for a multifaceted treatment trial to examine the early implementation of treatment approaches that may reduce prolonged recovery while considering the heterogeneous presentation of symptoms and patient preferences in the sub-acute stage following concussion. Randomized controlled trials that consider a multifaceted transdisciplinary approach to treatment in the early period following concussion are needed to raise the bar regarding evidence-informed management following concussion

Who can participate

Age range

13 Years – 19 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 - 19 years of age at the start of treatment * Diagnosed by the study physician with a concussion as per the 5th International Consensus Statement on Concussion in Sport1 * Glasgow Coma Scale 13-15 if recorded * Loss of consciousness \< 30 minutes if present * Post-traumatic amnesia \< 24 hours if present * Diagnosis within 2 weeks of injury * Moderate-severe symptoms of dizziness, neck pain, headaches, or sleep disturbance at \> one week and \< three weeks post injury reported on the PCSS (3-6 on 0-6 Likert scale for at least one of three symptoms) * Patients can have a history of migraine or a family history of migraine Exclusion Criteria: * Inability to communicate orally and/or in writing in English language * Significant developmental delay or intellectual disability * No access to smartphone or computer * Red flags or other clinical indication suggesting that further medical investigation is warranted (e.g., neurological scan - reflexes, dermatomes, myotomes, long tract signs, CN II-XII, Cerebellar Scan * Unresolved Benign Paroxysmal Positional Vertigo (BPPV) (Dix-Hallpike and Roll Test) * Inability to participate in physical activity for a reason other than concussion * Orthopedic or other injury precluding ability to participate * Medical history of neurological conditions: seizures (febrile SZ will be allowed), stroke, previous moderate/severe TBI, CNS cancers, SCI * Psychotic disorder * Inability to provide informed consent * History of su…

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 compared different symptom management approaches for concussion — do you know what treatments were being tested, and based on the results, which approach would you recommend for managing my headaches, neck pain, and dizziness?
2Since this trial is now completed, have the findings been published, and if so, do the results suggest any particular treatment strategy worked better for helping people return to unrestricted physical activity?
3This study focused on people with mild traumatic brain injury — given my specific symptoms and how long I've had them, do you think my situation is similar enough to the trial participants that the findings would apply to my care?
4The trial tracked both symptom changes and return to physical activity as its main goals — how do you currently measure my progress on those same outcomes, and does my timeline look typical compared to what this kind of research has shown?
5Before considering anything from this trial, are there established standard-of-care treatments for post-concussion symptoms that you'd want me to try first, and how would we decide if something more specialized is worth pursuing?

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

Change in symptoms

Timeframe: Collected at 6 weeks from the start of treatment

Return to unrestricted physical activity

Timeframe: Measured until 3 months from the start of treatment

Trial details

NCT IDNCT05446597

SponsorUniversity of Calgary

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01-31

View on ClinicalTrials.gov More Mild Traumatic Brain Injury trials