The Effect of Mild Traumatic Brain Injury on Recovery From Injury

This study has been completed.
Sponsor:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00295074
First received: February 17, 2006
Last updated: February 7, 2008
Last verified: February 2008
  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: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: The Effect of Mild Traumatic Brain Injury on Recovery From Injury

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov Identifier: NCT00295074     History of Changes
Other Study ID Numbers: 0402095
Study First Received: February 17, 2006
Last Updated: February 7, 2008
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:
Brain Concussion
Craniocerebral Trauma
Brain Injuries
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Head Injuries, Closed
Wounds, Nonpenetrating

ClinicalTrials.gov processed this record on August 01, 2014