Back to results

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

Primary Purpose

Mild Traumatic Brain Injury, Headaches Posttraumatic, Neck Pain

Status

Recruiting

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Symptom-specific Headache Treatment

Symptom-specific Dizziness &/or Neck Pain Treatment

Multimodal Concussion Treatment

About this trial

This is an interventional treatment trial for Mild Traumatic Brain Injury

Eligibility Criteria

13 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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
Steroid injection to the greater or lesser occipital nerve infiltration in past 3 months
Previously enrolled in the trial

Sites / Locations

University of CalgaryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Headache Treatment

Dizziness and/or Neck Pain Treatment

Multimodal Treatment

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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)

Return to unrestricted physical activity

Days from injury to physician clearance to return to unrestricted physical activity (e.g., physical education, sport, recreational activities)

Secondary Outcome Measures

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'.

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)]

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

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

Full Information

NCT ID

NCT05446597

First Posted

June 7, 2022

Last Updated

September 6, 2023

Sponsor

University of Calgary

Collaborators

Canadian Institutes of Health Research (CIHR)

1. Study Identification

Unique Protocol Identification Number

NCT05446597

Brief Title

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

Acronym

SMART

Official Title

Symptom Management vs Alternative Randomized Treatment of Concussion Trial

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 10, 2023 (Actual)

Primary Completion Date

April 30, 2025 (Anticipated)

Study Completion Date

April 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Calgary

Collaborators

Canadian Institutes of Health Research (CIHR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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: Headache treatment Neck pain / Dizziness treatment 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)

Allocation

Randomized

Enrollment

164 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Headache Treatment

Arm Type

Experimental

Arm Description

Arm Title

Dizziness and/or Neck Pain Treatment

Arm Type

Experimental

Arm Description

Arm Title

Multimodal Treatment

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Symptom-specific Headache Treatment

Intervention Description

Greater Occipital Nerve Block

Intervention Type

Other

Intervention Name(s)

Symptom-specific Dizziness &/or Neck Pain Treatment

Intervention Description

Cervicovestibular Physiotherapy Treatment

Intervention Type

Behavioral

Intervention Name(s)

Multimodal Concussion Treatment

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in symptoms

Description

Time Frame

Collected at 6 weeks from the start of treatment

Title

Return to unrestricted physical activity

Description

Days from injury to physician clearance to return to unrestricted physical activity (e.g., physical education, sport, recreational activities)

Time Frame

Measured until 3 months from the start of treatment

Secondary Outcome Measure Information:

Title

Change in symptoms on the Buffalo Concussion Treadmill Test

Description

Time Frame

Measured at 6 weeks from the start of treatment

Title

Changes in symptom-specific ratings

Description

Time Frame

Measured at 6 weeks from the start of treatment

Title

Change in quality of life rating

Description

Time Frame

Measured at 6 weeks from the start of treatment

Title

Change in resilience

Description

Time Frame

Measured at 6 weeks from the start of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

13 Years

Maximum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 Steroid injection to the greater or lesser occipital nerve infiltration in past 3 months Previously enrolled in the trial

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Heather Godfrey, MNNP, BSc, BN

Phone

4039552797

heather.godfrey@ahs.ca

First Name & Middle Initial & Last Name or Official Title & Degree

Astrid Han, Bsc

Phone

4036712852

astrid.han@ucalgary.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Carolyn Emery, PhD

Organizational Affiliation

University of Calgary

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Calgary

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 1N4

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Heather Godfrey, BSc, BN

Phone

4039552797

First Name & Middle Initial & Last Name & Degree

Lisa Marie Langevin, PhD

Phone

4039557254

First Name & Middle Initial & Last Name & Degree

Carolyn Emery, PhD

First Name & Middle Initial & Last Name & Degree

Keith Yeates, PhD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs