Influence of Cognitive Rest on Minor Traumatic Brain Injury

The Influence of Cognitive Rest and Graduated Return to Usual Activities on Minor Traumatic Brain Injury

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.

Study Overview

• Status: Completed
• Conditions: Minor Head Injury
• Intervention / Treatment: Other: Usual care; Other: Cognitive rest

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X5
      • Mount Sinai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 64 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control; The control arm receives usual care discharge instructions.	Other: Usual care; These are usual care emergency department discharge instructions provided at emergency department discharge for minor traumatic brain injury.
Experimental: Cognitive rest; The intervention is providing discharge instructions instructing cognitive rest and graduated return to usual activities in patients whom have experienced minor traumatic brain injury.	Other: Cognitive rest; The intervention is providing discharge instructions instructing cognitive rest and graduated return to usual activities in patients whom have experienced minor traumatic brain injury.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Minor traumatic brain injury symptoms	Measured by the Post-concussion Symptom Score (PCSS)	4 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Days of work or school missed	4 weeks
Visits to the emergency department or other health care professionals	4 weeks

Collaborators and Investigators

• Sponsor: Mount Sinai Hospital, Canada
• Investigators: Principal Investigator: Catherine E Varner, MD, Mount Sinai Hospital Division of Emergency Medicine

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: April 15, 2014
• First Submitted That Met QC Criteria: April 15, 2014
• First Posted (Estimate): April 17, 2014

Study Record Updates

• Last Update Posted (Estimate): September 24, 2015
• Last Update Submitted That Met QC Criteria: September 22, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: Concussion; Emergency department; Head injury; Cognitive rest
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic; Craniocerebral Trauma
• Other Study ID Numbers: MSHED0001