The Effect of Mild Traumatic Brain Injury on Recovery From Injury

Traumatic Brain Injury Clinical Trial

Official title:

The Effect of Mild Traumatic Brain Injury on Recovery From Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00295074
• Other study ID #: 0402095
• Status: Completed
• Phase: N/A
• First received: February 17, 2006
• Last updated: February 7, 2008
• Start date: October 2004
• Est. completion date: September 2007

Study information

• Verified date: February 2008
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Craniocerebral Trauma
• Head Injury
• Trauma
• Traumatic Brain Injury

Intervention

Procedure:
• neuropsychologic testing

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center-Presbyterian	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	functional outcome
Primary	subjective symptoms