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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured until 3 months from the start of treatment
Awards & highlights
SMART Trial 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.Check my eligibility
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.See study design
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.
SMART Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 13 and 19 years old.
Select...
I have lost consciousness for less than 30 minutes.
SMART Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in symptoms
Return to unrestricted physical activity
Secondary outcome measures
Change in quality of life rating
Change in resilience
Treadmill Test
+1 moreSMART 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.
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Who is running the clinical trial?
University of CalgaryLead Sponsor
792 Previous Clinical Trials
868,990 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,345 Previous Clinical Trials
26,453,603 Total Patients Enrolled
Carolyn Emery, PhDPrincipal InvestigatorUniversity of Calgary
1 Previous Clinical Trials
214 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I currently have active cancer.I do not have uncontrolled rheumatologic, inflammatory, or neurologic disorders, fibromyalgia/chronic fatigue syndrome, coagulopathy, or immunosuppression.I have had surgery in the back of my head.You have a mental illness that causes you to lose touch with reality.I have not had serious brain injuries, strokes, seizures (except fever-related), spinal cord injuries, or brain cancer.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.I have had a shingles infection in the past 6 months.You have symptoms that need to be checked further by a doctor, such as issues with reflexes, skin sensations, muscle strength, and other signs related to the nervous system.I can't do physical activities for reasons other than a concussion.I have not had a steroid injection in my head or neck in the last 3 months.You have a significant delay in learning or understanding things.I cannot communicate in English, either by speaking or writing.If your Glasgow Coma Scale score is between 13 and 15.I have ongoing dizziness when I move my head.You can have a history of migraine or a family history of migraine.I have an injury that stops me from joining.I am between 13 and 19 years old.I have lost consciousness for less than 30 minutes.The study doctor has diagnosed you with a concussion according to specific guidelines.I was diagnosed within 2 weeks of my injury.
Research Study Groups:
This trial has the following groups:- Group 1: Headache Treatment
- Group 2: Multimodal Treatment
- Group 3: Dizziness and/or Neck Pain Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you elaborate on the risks associated with Symptom-specific Headache Treatment?
"There is some data supporting the efficacy of Symptom-specific Headache Treatment and multiple rounds of data supporting its safety, so our team at Power estimates that it is a 3 on a scale from 1 to 3."
Answered by AI
Can patients currently enroll in this trial?
"No, this particular clinical trial is not recruiting patients at the moment. According to information on clinicaltrials.gov, which last updated on November 1st 2022, this study was first posted on January 1st 2023 and has yet to resume recruitment. There are 618 other active trials that may be of interest however."
Answered by AI
What are the parameters of success for this experiment?
"The primary objective of this trial is to assess change in symptoms over a period of 3 months. Secondary objectives include measuring changes in quality of life, symptom-specific ratings, and resilience. Quality of life will be measured using the Pediatric Quality of Life Inventory V4.0 (PedsQL) at 6 weeks, with scores ranging from 0 to 94. Symptom-specific ratings will be measured using the Post-Concussion Symptom Score (PCSS /132) at 6 weeks, with scores ranging from 0 to 6. Resilience will be measured using the Connor-Davidson Resilience Scale ("
Answered by AI
Does this research allow for octogenarians?
"The target enrolment demographic for this clinical trial are individuals who have not yet reached their 20th birthday but are above the age of 13."
Answered by AI
How can I sign up for this opportunity to help medical research?
"This trial is meant for adolescents that have received brain injuries and are between the ages of 13 to 19. Up to 294 people will be allowed into the study."
Answered by AI
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