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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
University of Pittsburgh
About
Eligibility
Locations
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
February 17, 2006
Last Updated
February 7, 2008
Sponsor
University of Pittsburgh
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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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