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

NCT05446597 | Unknown DMC

• 1 other identifier: REB21-1045
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

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

Conditions

Mild Traumatic Brain Injury; Headaches Posttraumatic; Neck Pain; Dizziness

Outcome Measures

Primary Outcomes (2)

• 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)

  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 until 3 months from the start of treatment

Secondary Outcomes (4)

• Change in symptoms on the Buffalo Concussion Treadmill Test

  Measured at 6 weeks from the start of treatment

• Changes in symptom-specific ratings

  Measured at 6 weeks from the start of treatment

• Change in quality of life rating

  Measured at 6 weeks from the start of treatment

• Change in resilience

  Measured at 6 weeks from the start of treatment

Study Arms (3)

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.

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.

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.

Behavioral: Multimodal Concussion Treatment

Interventions

Symptom-specific Headache Treatment PROCEDURE

Greater Occipital Nerve Block

Headache Treatment

Symptom-specific Dizziness &/or Neck Pain Treatment OTHER

Cervicovestibular Physiotherapy Treatment

Dizziness and/or Neck Pain Treatment

Multimodal Concussion Treatment BEHAVIORAL

Lite combination of headache advice, general physiotherapy exercises, mindfulness, visualization, and relaxation

Dizziness and/or Neck Pain Treatment; Headache Treatment; Multimodal Treatment

Eligibility Criteria

• Age: 13 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 1N4, Canada

RECRUITING

MeSH Terms

Conditions

Brain Concussion; Post-Traumatic Headache; Neck Pain; Dizziness

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating; Headache Disorders, Secondary; Headache Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sensation Disorders

Study Officials

• Carolyn Emery, PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heather Godfrey, MNNP, BSc, BN

CONTACT

4039552797; heather.godfrey@ahs.ca

Astrid Han, Bsc

CONTACT

4036712852; astrid.han@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: June 7, 2022
• First Posted: July 6, 2022
• Study Start: April 10, 2023
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: September 11, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)