Influence of Cognitive Rest on Minor Traumatic Brain Injury

NCT02116673 | Completed

• 1 other identifier: MSHED0001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Minor Head Injury

Keywords

Head injury; Concussion; Cognitive rest; Emergency department

Outcome Measures

Primary Outcomes (1)

• Minor traumatic brain injury symptoms

  Measured by the Post-concussion Symptom Score (PCSS)

  4 weeks

Secondary Outcomes (2)

• Days of work or school missed

  4 weeks

• Visits to the emergency department or other health care professionals

  4 weeks

Study Arms (2)

Control

OTHER

The control arm receives usual care discharge instructions.

Other: Usual care

Cognitive rest

EXPERIMENTAL

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

Interventions

Cognitive rest OTHER

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

Cognitive rest

Usual care OTHER

These are usual care emergency department discharge instructions provided at emergency department discharge for minor traumatic brain injury.

Control

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• Acute intracranial injury identified on head CT
• Glasgow Coma Scale (GCS) \< 15 at time of discharge
• Non-English speaking

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

MeSH Terms

Conditions

Craniocerebral Trauma; Brain Concussion; Emergencies

Condition Hierarchy (Ancestors)

Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Head Injuries, Closed; Wounds, Nonpenetrating; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Catherine E Varner, MD

  Mount Sinai Hospital Division of Emergency Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Emergency Physician

Study Record Dates

• First Submitted: April 15, 2014
• First Posted: April 17, 2014
• Study Start: July 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: September 24, 2015

Record last verified: 2015-09

Locations

CA (1)