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The Effect of Mild Traumatic Brain Injury on Recovery From Injury

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ClinicalTrials.gov Identifier: NCT00295074
Recruitment Status : Completed
First Posted : February 22, 2006
Last Update Posted : February 11, 2008
Sponsor:
Information provided by:
University of Pittsburgh

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.

Condition or disease Intervention/treatment
Traumatic Brain Injury Trauma Head Injury Brain Concussion Procedure: neuropsychologic testing

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  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Effect of Mild Traumatic Brain Injury on Recovery From Injury
Study Start Date : October 2004
Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. functional outcome
  2. subjective symptoms


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00295074     History of Changes
Other Study ID Numbers: 0402095
First Posted: February 22, 2006    Key Record Dates
Last Update Posted: February 11, 2008
Last Verified: February 2008

Keywords provided by University of Pittsburgh:
traumatic brain injury
head injury
concussion
neuropsychologic test

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Concussion
Craniocerebral Trauma
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Head Injuries, Closed
Wounds, Nonpenetrating