Minor Head Injury Clinical Trial
Official title:
The Influence of Cognitive Rest and Graduated Return to Usual Activities on Minor Traumatic Brain Injury
Verified date | September 2015 |
Source | Mount Sinai Hospital, Canada |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Institutional Review Board |
Study type | Interventional |
Background: Head injury is a common presentation to family medicine clinics and emergency
departments (EDs), and the majority will not result in intracranial injury requiring
neurosurgical consultation, but will have symptoms of mild traumatic brain injury (MTBI). It
is estimated between 15-50% of patients with MTBI develop post-concussive syndrome (PCS).
Research in the management of MTBI and prevention of PCS has been scarce to date. Although
expert consensus recommends cognitive rest and graduated return to usual activities, these
and other interventions are not based on prospective clinical evidence.
Objective: The purpose of this study is to determine if providing graduated return to usual
activities discharge instructions to MTBI patients in the ED decreases MTBI symptoms
post-injury as compared to providing usual ED MTBI discharge instructions.
Study Design: This will be a pragmatic, single-centered, 2-arm parallel-group, superiority
randomized trial.
Patient Population: Male and female patients presenting to the ED ages greater than 17 and
less than 65 with the Canadian Emergency Department Information System (CEDIS) presenting
complaint of "head injury".
Outcomes: The primary outcome of this study is to determine if patients whom receive
graduated return to usual activity discharge instructions have more clinically significant
decreases in their Post-Concussion Symptom Score (PCSS) 2 weeks after MTBI versus patients
who received usual care MTBI discharge instructions. Secondary outcomes include the
intervention group's compliance with the intervention, comparison of PCSS between groups 4
weeks after initial ED visit, comparison of groups' number of return visit(s) to either an
ED or physician's office, and the mean number of days of school or work missed for each
group.
Hypothesis: Given cognitive rest and graduated return to usual activities are concepts
recommended by expert consensus, it is expected patients who follow the graduated return to
usual activities and cognitive rest guidelines will have less MTBI symptoms at two weeks
after ED discharge.
Status | Completed |
Enrollment | 120 |
Est. completion date | July 2015 |
Est. primary completion date | July 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 17 Years to 64 Years |
Eligibility |
Inclusion Criteria: - Male and female patients presenting to the ED with the Canadian Emergency Department Information System (CEDIS) chief complaint of "head injury". - Age greater than 17 years and less than 65 years. - Injury occurring within the last 24 hours. Exclusion Criteria: - Acute intracranial injury identified on head CT - Glasgow Coma Scale (GCS) < 15 at time of discharge - Non-English speaking |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Mount Sinai Hospital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Mount Sinai Hospital, Canada |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Minor traumatic brain injury symptoms | Measured by the Post-concussion Symptom Score (PCSS) | 4 weeks | No |
Secondary | Days of work or school missed | 4 weeks | No | |
Secondary | Visits to the emergency department or other health care professionals | 4 weeks | No |
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