The Effect of Mild Traumatic Brain Injury on Recovery From Injury
Primary Purpose
Traumatic Brain Injury, Trauma, Head Injury
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
neuropsychologic testing
Sponsored by
About this trial
This is an interventional diagnostic trial for Traumatic Brain Injury focused on measuring traumatic brain injury, head injury, concussion, neuropsychologic test
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
Sites / Locations
- University of Pittsburgh Medical Center-Presbyterian
Outcomes
Primary Outcome Measures
functional outcome
subjective symptoms
Secondary Outcome Measures
Full Information
NCT ID
NCT00295074
First Posted
February 17, 2006
Last Updated
February 7, 2008
Sponsor
University of Pittsburgh
1. Study Identification
Unique Protocol Identification Number
NCT00295074
Brief Title
The Effect of Mild Traumatic Brain Injury on Recovery From Injury
Official Title
The Effect of Mild Traumatic Brain Injury on Recovery From Injury
Study Type
Interventional
2. Study Status
Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Pittsburgh
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury, Trauma, Head Injury, Brain Concussion
Keywords
traumatic brain injury, head injury, concussion, neuropsychologic test
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
800 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
neuropsychologic testing
Primary Outcome Measure Information:
Title
functional outcome
Title
subjective symptoms
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian G Harbrecht, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh Medical Center-Presbyterian
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Effect of Mild Traumatic Brain Injury on Recovery From Injury
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