Treatment options for youth with concussion symptoms
Symptom Management vs Alternative Randomized Treatment of Concussion Trial
This study tests whether specific treatments for headaches, dizziness, and neck pain can help teenagers aged 13-19 recover faster after a concussion.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 164 (estimated) |
| Ages | 13 Years to 19 Years |
| Sex | All |
| Sponsor | University of Calgary Academic / other |
| Locations | 1 site (Calgary, Alberta) |
| Trial ID | NCT05446597 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of symptom-specific treatments for headaches, dizziness, and neck pain in adolescents aged 13-19 who have recently suffered a concussion. Participants will be randomly assigned to receive either targeted symptom management or a multimodal treatment approach within two weeks of their injury. The study aims to determine which treatment leads to better symptom relief and quicker clearance for physical activity. By focusing on a multifaceted approach, the trial seeks to address the diverse symptoms experienced by young patients post-concussion.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 13-19 who have been diagnosed with a concussion within two weeks and are experiencing moderate to severe symptoms.
Not a fit: Patients with significant developmental delays, intellectual disabilities, or those requiring further medical investigation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide effective treatment strategies that reduce recovery time and improve outcomes for young patients with concussions.
How similar studies have performed: While there is limited research on multifaceted treatment approaches for concussion, this trial aims to fill a gap in the existing literature, making it a novel endeavor.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Calgary, Alberta
- University of Calgary — Calgary, Alberta, Canada (Recruiting)
Study contacts
- Principal investigator: Carolyn Emery, PhD — University of Calgary
- Study coordinator: Heather Godfrey, MNNP, BSc, BN
- Email: heather.godfrey@ahs.ca
- Phone: 4039552797
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.