- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00295074
The Effect of Mild Traumatic Brain Injury on Recovery From Injury
February 7, 2008 updated by: University of Pittsburgh
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
800
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh Medical Center-Presbyterian
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
functional outcome
|
subjective symptoms
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Brian G Harbrecht, MD, University of Pittsburgh
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2004
Study Completion (Actual)
September 1, 2007
Study Registration Dates
First Submitted
February 17, 2006
First Submitted That Met QC Criteria
February 17, 2006
First Posted (Estimate)
February 22, 2006
Study Record Updates
Last Update Posted (Estimate)
February 11, 2008
Last Update Submitted That Met QC Criteria
February 7, 2008
Last Verified
February 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0402095
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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