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

Launched by UNIVERSITY OF CALGARY · Jul 5, 2022

Keywords

ClinConnect Summary

The SMART Concussion Trial is researching different ways to treat young people who have had a concussion, specifically those aged 13 to 19. With many kids and teens suffering from symptoms like headaches, dizziness, and neck pain for weeks or even months after a concussion, this study aims to find effective treatment strategies that can help them recover faster. The trial is looking for participants who have been diagnosed with a concussion within the last two weeks and have moderate to severe symptoms.

If you or someone you know fits this description, you might be eligible to participate. Participants will receive a comprehensive treatment plan tailored to their specific symptoms, and the goal is to improve recovery times while considering what each individual needs. It's important to note that certain conditions, such as severe medical issues or past neurological conditions, may prevent someone from being involved in the trial. This study is currently recruiting participants, and it represents a valuable opportunity to contribute to better concussion care for young people.

Gender

ALL

Eligibility criteria

• 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 surgery in the occipital region
• • Uncontrolled rheumatologic, inflammatory, or neurologic disorders (eg MS); Fibromyalgia/chronic fatigue syndrome; coagulopathy; immunosuppression
• • Active cancer
• • Herpes zoster infection in last 6 months
• • Pregnancy
• • Steroid injection to the greater or lesser occipital nerve infiltration in past 3 months
• • Previously enrolled in the trial