The Effect of Mild Traumatic Brain Injury on Recovery From Injury - Full Text View

Sponsor:	University of Pittsburgh
Information provided by:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00295074

Purpose

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.

Condition	Intervention
Traumatic Brain Injury Trauma Head Injury Brain Concussion	Procedure: neuropsychologic testing

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title:	The Effect of Mild Traumatic Brain Injury on Recovery From Injury

Resource links provided by NLM:

MedlinePlus related topics: Concussion Injuries Traumatic Brain Injury Wounds

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:

functional outcome
subjective symptoms

Estimated Enrollment:	800
Study Start Date:	October 2004
Study Completion Date:	September 2007

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00295074

Locations

United States, Pennsylvania
University of Pittsburgh Medical Center-Presbyterian
Pittsburgh, Pennsylvania, United States, 15213

Sponsors and Collaborators

University of Pittsburgh

Investigators

Principal Investigator:

Brian G Harbrecht, MD

University of Pittsburgh

More Information

No publications provided

Study ID Numbers:	0402095
Study First Received:	February 17, 2006
Last Updated:	February 7, 2008
ClinicalTrials.gov Identifier:	NCT00295074 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Pittsburgh:

traumatic brain injury
head injury
concussion
neuropsychologic test

Additional relevant MeSH terms:

Craniocerebral Trauma
Brain Concussion
Nervous System Diseases
Wounds and Injuries
Disorders of Environmental Origin
Head Injuries, Closed

Central Nervous System Diseases
Wounds, Nonpenetrating
Trauma, Nervous System
Brain Diseases
Brain Injuries

ClinicalTrials.gov processed this record on February 08, 2010