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

Not Applicable

Recruiting

• Conditions: Neck Pain; Dizziness; Mild Traumatic Brain Injury; Headaches Posttraumatic

• Registration Number: NCT05446597
• Lead Sponsor: University of Calgary

Brief 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

Detailed Description

The primary objective of this RCT is to examine if up to 6-weeks of symptom-specific (1. headache, 2. dizziness and/or neck pain) treatment initiated in the acute/sub-acute stages following concussion in 13-19 year-old participants recruited acutely (within 2 weeks) following concussion are superior to up to 6 weeks of a multimodal, non-symptom specific treatment program. Treatment will cease once participants are cleared to return to unrestricted physical activity by a sports medicine physician, and will therefore last up to 6 weeks. We have two primary outcomes:

1. Post-Concussion Total Symptom Score (PCSS /132) on the SCAT5 following treatment of up to six sessions

2. Days from injury to physician clearance to return to unrestricted physical activity (e.g., physical education, sport, recreational activities)

Study Timeline

• Study First Submitted: 2022-06-07
• Study First Submitted QC: 2022-07-05
• Study First Posted: 2022-07-06
• Study Start: 2023-04-10
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-06
• Last Update Posted: 2023-09-11
• Primary Completion: 2025-04-30
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 164

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in symptoms	Collected at 6 weeks from the start of treatment	Change from baseline in symptom burden, measured by the Post-Concussion Symptom Score (PCSS /132) on the SCAT5 (Sport Concussion Assessment Tool - 5th Edition) at 6 weeks following initiation of treatment. Options for scores are: none (0), mild (1), moderate (2), or severe (3) in 22 symptom categories, for a total score of 0 (no symptoms) to 132 (severe symptoms in all categories)
Return to unrestricted physical activity	Measured until 3 months from the start of treatment	Days from injury to physician clearance to return to unrestricted physical activity (e.g., physical education, sport, recreational activities)

Secondary Outcome Measures

Name	Time	Method
Change in symptoms on the Buffalo Concussion Treadmill Test	Measured at 6 weeks from the start of treatment	Change in overall symptoms \[visual analogue scale (VAS) 0-10\] from rest prior to the Buffalo Concussion Treadmill Test (BCTT) to age-predicted 80% maximum heart rate on the BCTT at 6-weeks. 0 indicates 'Feeling Good' up to 10 'Worst I have ever felt'.
Change in quality of life rating	Measured at 6 weeks from the start of treatment	Pediatric Quality of Life Inventory V4.0 (PedsQL) at 6-weeks. Likert scale: never a problem (0) to sometimes (2) to almost always (4). Total symptom scores from 0/94 up to 94/94. Higher scores indicate poorer quality of life
Change in resilience	Measured at 6 weeks from the start of treatment	Resilience at 6-weeks using the short, 10-item Connor-Davidson Resilience Scale (CD-RISC). Respondents rate items on a 5-point Likert scale, ranging from 0 (not true at all) to 4 (true nearly all the time) for a score range of 0-40. A higher score indicates higher resilience
Changes in symptom-specific ratings	Measured at 6 weeks from the start of treatment	Symptom-specific PCSS \[Post-Concussion Symptom Score (PCSS /132)\] ratings of headache, dizziness/neck pain, and sleep disturbance \[0-6 Likert scale; from no symptoms (0), to moderate (3), to severe (6)\]

Trial Locations

Locations (1)

University of Calgary; 🇨🇦 Calgary, Alberta, Canada