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Minor Head Injury | Influence of Cognitive Rest on Minor Traumatic Brain Injury

Minor Head Injury research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Minor Head Injury

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Other:Cognitive restThe intervention is providing discharge instructions instructing cognitive rest and graduated return to usual activities in patients whom have experienced minor traumatic brain injury.

Other:Usual careThese are usual care emergency department discharge instructions provided at emergency department discharge for minor traumatic brain injury.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

ControlThe control arm receives usual care discharge instructions.

Cognitive restThe intervention is providing discharge instructions instructing cognitive rest and graduated return to usual activities in patients whom have experienced minor traumatic brain injury.

Study Status

Completed

Start Date: July 2014

Completed Date: July 2015

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Minor traumatic brain injury symptoms

Secondary Outcome: Days of work or school missed

Study sponsors, principal investigator, and references

Principal Investigator: Catherine E Varner, MD

Lead Sponsor: Mount Sinai Hospital, Canada

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02116673

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