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Behavioral Intervention

Multimodal vs Symptom-Specific Treatments for Concussion (SMART Trial)

N/A

Recruiting

Led By Carolyn Emery, PhD

Research Sponsored by University of Calgary

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

13 - 19 years of age at the start of treatment

Loss of consciousness < 30 minutes if present

Must not have

Active cancer

Uncontrolled rheumatologic, inflammatory, or neurologic disorders (eg MS); Fibromyalgia/chronic fatigue syndrome; coagulopathy; immunosuppression

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured until 3 months from the start of treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at the efficacy of different treatment strategies for concussions, specifically in children and adults. It aims to find which treatments work best in the early stages following a concussion, in order to reduce prolonged recovery times.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed here, multimodal treatments can include medication that may cause nausea or sleep issues; physical therapies might lead to temporary increased discomfort; psychological support could bring up emotional responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 13 and 19 years old.

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I have lost consciousness for less than 30 minutes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I currently have active cancer.

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I do not have uncontrolled rheumatologic, inflammatory, or neurologic disorders, fibromyalgia/chronic fatigue syndrome, coagulopathy, or immunosuppression.

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I have had surgery in the back of my head.

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I have not had serious brain injuries, strokes, seizures (except fever-related), spinal cord injuries, or brain cancer.

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I have had a shingles infection in the past 6 months.

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I can't do physical activities for reasons other than a concussion.

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I cannot communicate in English, either by speaking or writing.

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I have ongoing dizziness when I move my head.

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I have an injury that stops me from joining.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured until 3 months from the start of treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured until 3 months from the start of treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured until 3 months from the start of treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in symptoms

Return to unrestricted physical activity

Secondary study objectives

Change in quality of life rating

Change in resilience

Treadmill Test

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Multimodal TreatmentExperimental Treatment1 Intervention

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.

Group II: Headache TreatmentExperimental Treatment2 Interventions

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.

Group III: Dizziness and/or Neck Pain TreatmentExperimental Treatment2 Interventions

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.

0 / 11Eligibility criteria met