The Effect of Mild Traumatic Brain Injury on Recovery From Injury

NCT ID: NCT00295074

Last Updated: 2008-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-10-31
• Study Completion Date: 2007-09-30

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.

Conditions

Traumatic Brain Injury; Trauma; Head Injury; Brain Concussion

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

neuropsychologic testing

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: lead

Principal Investigators

Brian G Harbrecht, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

University of Pittsburgh Medical Center-Presbyterian

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

0402095

Identifier Type: -

Identifier Source: org_study_id