The Effect of Mild Traumatic Brain Injury on Recovery From Injury

Not Applicable

Completed

• Conditions: Trauma; Head Injury; Traumatic Brain Injury; Brain Concussion

• Registration Number: NCT00295074
• Lead Sponsor: University of Pittsburgh

Brief Summary

Mild traumatic brain injury (TBI) is a common injury that can produce significant functional sequelae and ongoing disabling symptoms. Predicting who will have an uncomplicated recovery and who will suffer ongoing symptoms is difficult. This protocol evaluates the use of neuropsychologic testing after mild TBI in injured patients to attempt to objectively establish predictors of long term disability and functional recovery.

Detailed Description

Patients who are hospitalized and who have suffered mild TBI (loss of consciousness or post-traumatic amnesia; Glasgow Coma Score 13-15; admitted within 24 hours of injury; able to read, speak, and understand English) who do not have pre-injury dementia or significant cognitive impairment will undergo computerized neuropsychologic testing using a previously validated tool that has been effective in sports-related mild TBI. Sequential testing will be performed during recovery and patients who report disabling symptoms and/or functional impairment will be compared to patients who recover uneventfully. Goal is to identify those parameters that predict early who may suffer long term sequelae or functional impairment and therefore benefit from early cognitive rehabilitation. Secondary goals are to establish objective parameters for functional recovery after mild TBI.

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2006-02-17
• Study First Submitted QC: 2006-02-17
• Study First Posted: 2006-02-22
• Study Completion: 2007-09
• Status Verified: 2008-02
• Last Update Submitted: 2008-02-07
• Last Update Posted: 2008-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

• Mild TBI
• Admitted within 24 hours of injury
• Able to read, speak,and understand English

Exclusion Criteria

• Expected to die of their injuries
• Pre-existing dementia or significant cognitive impairment
• Neurologically impaired and incapable of completing testing
• Physically incapable of using arms/hands to complete computerized testing

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
functional outcome
subjective symptoms

Trial Locations

Locations (1)

University of Pittsburgh Medical Center-Presbyterian; 🇺🇸 Pittsburgh, Pennsylvania, United States