Mild Traumatic Brain InjurySMARTNCT05446597
SMART Concussion Trial: Symptom Management vs Alternative Randomized Treatment of Concussion Trial
A study testing Symptom-specific Headache Treatment, Symptom-specific Dizziness &/or Neck Pain Treatment and Multimodal Concussion Treatment in people with Mild Traumatic Brain Injury and Headaches Posttraumatic, run by University of Calgary at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 19 years
- Conditions the study is for
- Mild Traumatic Brain Injury, Headaches Posttraumatic, Neck Pain
- What is being tested?
- Symptom-specific Headache Treatment, Symptom-specific Dizziness &/or Neck Pain Treatment and Multimodal Concussion Treatment
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteCanada
- Study dates
- 10 Apr 2023to 31 Jan 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Symptom Management vs Alternative Randomized Treatment of Concussion Trial
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
Read the 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:
- Post-Concussion Total Symptom Score (PCSS /132) on the SCAT5 following treatment of up to six sessions
- Days from injury to physician clearance to return to unrestricted physical activity (e.g., physical education, sport, recreational activities)
- Being tested
- Symptom-specific Headache Treatment, Symptom-specific Dizziness &/or Neck Pain Treatment, Multimodal Concussion Treatment
- Medical subject headings
- Brain Concussion, Post-Traumatic Headache, Neck Pain, Dizziness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Symptom-specific Headache TreatmentProcedure or surgery
Greater Occipital Nerve Block
Symptom-specific Dizziness &/or Neck Pain TreatmentOther
Cervicovestibular Physiotherapy Treatment
Multimodal Concussion TreatmentBehavioural
Lite combination of headache advice, general physiotherapy exercises, mindfulness, visualization, and relaxation
| Study group | Role | What they receive |
|---|---|---|
| Headache Treatment | Experimental | Participants in the headache arm will be randomized to receive a peripheral, greater occipital nerve block with 0.5% Bupivacaine or the multimodal treatment protocol. Participants will complete a daily headache diary over the 6-week treatment period, following a link on their mobile device. Patients receiving a nerve block will have weekly over-the-phone or virtual check-ins by the study team to evaluate for any side effects, pain, as needed medications, and study compliance. These patients will be given supplemental HA education as needed. Participants receiving the block will be offered a second block at 6 weeks if they meet the following criteria: a. no side effects with the first block, b. participant received relief from the first block and prefers a second, and c. headache is still occurring at least once per week. Participants randomized to the multimodal treatment portion, will have up to 6 weeks of scheduled multimodal treatment sessions. Receives: Procedure: Symptom-specific Headache Treatment; Behavioral: Multimodal Concussion Treatment |
| Dizziness and/or Neck Pain Treatment | Experimental | Participants will be randomized to receive cervicovestibular physiotherapy (CV PT) or the multimodal treatment program. The CV PT group will participate in a combination of cervical spine and vestibular rehabilitation as per a standardized treatment algorithm based on individual assessment findings for six weeks. This form of therapy combines treatment techniques for both the cervical spine and vestibular system that are commonly used in physiotherapy practice. Cervical spine treatments may include neuromotor retraining, sensorimotor retraining, manual therapy, soft tissue techniques, and range of motion exercises. Vestibular rehabilitation may include gaze stabilization, habituation, standing balance, and dynamic balance. Receives: Other: Symptom-specific Dizziness &/or Neck Pain Treatment; Behavioral: Multimodal Concussion Treatment |
| Multimodal Treatment | Experimental | The multimodal treatment consists of 6 treatment sessions that will combine basic physiotherapy exercises to address dizziness and balance problems, training in deep breathing, progressive muscle relaxation, visualization to address headache, sleep hygiene education to address insomnia, and cognitive-behavioral intervention and gratitude exercises to promote coping and resilience. The treatment is designed to be implemented by a variety of clinical health care professionals. Receives: Behavioral: Multimodal Concussion Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in symptoms
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)
Measured: Collected at 6 weeks from the start of treatment
Return to unrestricted physical activity
Days from injury to physician clearance to return to unrestricted physical activity (e.g., physical education, sport, recreational activities)
Measured: Measured until 3 months from the start of treatment
Secondary outcomes (4)
Change in symptoms on the Buffalo Concussion Treadmill Test
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'.
Measured: Measured at 6 weeks from the start of treatment
Changes in symptom-specific ratings
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)]
Measured: Measured at 6 weeks from the start of treatment
Change in quality of life rating
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
Measured: Measured at 6 weeks from the start of treatment
Change in resilience
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
Measured: Measured at 6 weeks from the start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start10 Apr 2023
- Primary completion31 Jan 2025
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a single-blind randomized controlled superiority trial with three treatment groups. Trial participants will be screened for headache and neck pain/dizziness based on symptom ratings on the Sport Concussion Assessment Tool 5 (SCAT5) Post-Concussion Symptom Scale (PCSS) (rating 0-2 mild, 3-4 moderate, 5-6 severe /6). Patients will be allocated to one of three treatments based on symptom severity: 1. Headache treatment 2. Neck pain / Dizziness treatment 3. Multimodal treatment All participants will receive standard of care education and exercise recommendations based on BCTT and sub-symptom threshold tolerance at baseline
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Carolyn Emery, PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05446597
- Sponsor's protocol ID
- REB21-1045
- Acronym
- SMART
- Status last verified
- Jun 2026
- First submitted
- 7 Jun 2022
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No