164 Participants Needed

Multimodal vs Symptom-Specific Treatments for Concussion

(SMART Trial)

HG
LM
HG
AH
Overseen ByAstrid Han, Bsc
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: University of Calgary
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this 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

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is the multimodal or symptom-specific treatment for concussion safe for humans?

Research indicates that treatments involving physical therapy and multidisciplinary care for concussion, including neck treatment and symptom-specific approaches, are generally safe. Participants in studies reported improvements in symptoms like headache, dizziness, and neck pain, although some experienced recurrent symptoms over time.12345

How is the Multimodal vs Symptom-Specific Treatments for Concussion unique compared to other treatments?

This treatment is unique because it combines multiple approaches, such as physical therapy, vestibular rehabilitation, and symptom-specific treatments for dizziness, neck pain, headaches, and sleep disturbances, to address the diverse symptoms of post-concussion syndrome. This comprehensive, multidisciplinary approach aims to improve recovery by targeting the specific needs of each patient, unlike standard treatments that may focus on only one aspect of the condition.13567

What data supports the effectiveness of the treatment for concussion?

Research suggests that a multimodal approach, including physical therapy and neck treatment, can help manage symptoms like headache, dizziness, and neck pain in people with persistent post-concussion symptoms. Studies indicate that these treatments can improve or sustain symptom relief over time, although some symptoms may recur.13578

Who Is on the Research Team?

CE

Carolyn Emery, PhD

Principal Investigator

University of Calgary

Are You a Good Fit for This Trial?

The SMART Concussion Trial is for young people aged 13-19 who've had a concussion with symptoms like headaches, dizziness, or neck pain lasting over a week but less than three weeks. They must be able to communicate in English and have access to a smartphone or computer. Those with severe brain injuries, certain medical conditions, or an inability to participate in physical activities due to reasons other than the concussion cannot join.

Inclusion Criteria

I've had moderate to severe dizziness, neck pain, headaches, or sleep issues for 1-3 weeks.
If you have memory loss from an injury for less than a day, you cannot participate.
If your Glasgow Coma Scale score is between 13 and 15.
See 5 more

Exclusion Criteria

I currently have active cancer.
Inability to provide informed consent
I do not have uncontrolled rheumatologic, inflammatory, or neurologic disorders, fibromyalgia/chronic fatigue syndrome, coagulopathy, or immunosuppression.
See 14 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks
1 visit (in-person)

Treatment

Participants receive symptom-specific or multimodal treatment for up to 6 weeks, including headache treatment, dizziness/neck pain treatment, or a combination of physiotherapy and cognitive-behavioral interventions.

6 weeks
6 sessions (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of symptom changes and quality of life.

6 weeks
2 visits (virtual)

Long-term Follow-up

Participants are monitored for return to unrestricted physical activity and long-term outcomes.

3 months

What Are the Treatments Tested in This Trial?

Interventions

  • Generic Concussion Treatment
  • Symptom-specific Dizziness &/or Neck Pain Treatment
  • Symptom-specific Headache Treatment
  • Symptom-specific Sleep Disturbance Treatment
Trial Overview This trial tests multiple treatments for concussions in youth. It's looking at how effective different symptom-specific approaches are when started early after injury. The study uses randomized controlled methods meaning participants are randomly assigned to treatment groups without choosing which one they receive.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Group I: Multimodal TreatmentExperimental Treatment1 Intervention
Group II: Headache TreatmentExperimental Treatment2 Interventions
Group III: Dizziness and/or Neck Pain TreatmentExperimental Treatment2 Interventions

Generic Concussion Treatment is already approved in United States, Canada, European Union for the following indications:

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Approved in United States as Generic Concussion Treatment for:
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Approved in Canada as Generic Concussion Treatment for:
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Approved in European Union as Generic Concussion Treatment for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials
827
Recruited
902,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials
1,417
Recruited
26,550,000+

Published Research Related to This Trial

In a study of 11 individuals with persistent concussion symptoms, neck treatment as part of multidisciplinary care led to sustained improvements in post-concussion symptoms over 6 and 12 months.
While most participants found neck treatment beneficial for their recovery, 7 out of 11 reported recurring headaches, neck pain, or dizziness, indicating that while neck treatment is helpful, some symptoms may persist long-term.
Can the neck contribute to persistent symptoms post concussion? Long-term follow up from a prospective descriptive case series.Kennedy, E., Chapple, C., Quinn, D., et al.[2022]
A multidisciplinary approach is essential for effectively managing concussions in children and adolescents, highlighting the importance of Physical Therapists in the recovery process.
Targeted treatments such as vestibular rehabilitation, cervicogenic rehabilitation, and exertional training can help alleviate common concussion symptoms like headache, dizziness, and balance dysfunction.
The Role of Physical Therapy in Concussion Rehabilitation.Brown, L., Camarinos, J.[2020]
Postconcussion syndrome (PCS) is a complex condition with symptoms that can persist for months or years, and it can be divided into early-phase and late-phase posttraumatic disorders, influenced by various psychosocial factors.
Effective treatment for PCS requires a careful diagnosis of symptoms and comorbid conditions, with a recommended approach that includes managing treatable symptoms and incorporating guided aerobic exercise to aid recovery.
Postconcussion syndrome.Dwyer, B., Katz, DI.[2019]

Citations

Can the neck contribute to persistent symptoms post concussion? Long-term follow up from a prospective descriptive case series. [2022]
The Role of Physical Therapy in Concussion Rehabilitation. [2020]
Postconcussion syndrome. [2019]
Osteopathic Manipulative Treatment Relieves Post-concussion Symptoms in a Case of Polytrauma. [2020]
The Utility of Neuromotor Retraining to Augment Manual Therapy and Vestibular Rehabilitation in a Patient with Post-Concussion Syndrome: A Case Report. [2023]
Concussion in Combination With Whiplash-Associated Disorder May Be Missed in Primary Care: Key Recommendations for Assessment and Management. [2020]
A Treatment-Based Profiling Model for Physical Therapy Management of Patients Following a Concussive Event. [2020]
Rehabilitation Assessment and Management of Neurosensory Deficits After Traumatic Brain Injury in the Polytrauma Veteran. [2018]
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