Traumatic Brain InjuryNCT00295074
The Effect of Mild Traumatic Brain Injury on Recovery From Injury
A study testing neuropsychologic testing in people with Traumatic Brain Injury and Trauma, run by University of Pittsburgh at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury, Trauma, Head Injury
- What is being tested?
- neuropsychologic testing
- Type of treatment
- Surgery or procedure
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2004to Sep 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mild TBI
- Admitted within 24 hours of injury
- Able to read, speak,and understand English
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center-Presbyterian
Pittsburgh, Pennsylvania, 15213
About this study
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.
Read the 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.
- Conditions
- Traumatic Brain Injury, Trauma, Head Injury, Brain Concussion
- Being tested
- neuropsychologic testing
- Keywords
- traumatic brain injury, head injury, concussion, neuropsychologic test
- Medical subject headings
- Brain Injuries, Traumatic, Wounds and Injuries, Craniocerebral Trauma, Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neuropsychologic testingProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
functional outcome
subjective symptoms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2006 (estimated)
- Study startOct 2004
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Investigators
- Brian G Harbrecht, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00295074
- Sponsor's protocol ID
- 0402095
- Status last verified
- Feb 2008
- First submitted
- 17 Feb 2006
- Last updated
- 11 Feb 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mild Traumatic Brain Injury on Recovery From Injury
- ClinicalTrials.gov ID
- NCT00295074
- Acronym / sponsor ID
- 0402095
- Conditions
- Traumatic Brain Injury, Trauma, Head Injury, Brain Concussion
- Keywords
- traumatic brain injury, head injury, concussion, neuropsychologic test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Oct 2004
- Study completion
- Sep 2007 (actual)
- First posted
- 22 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Mild TBI
- Admitted within 24 hours of injury
- Able to read, speak,and understand English
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neuropsychologic testing | Procedure or surgery | – |
Primary outcome
functional outcome
subjective symptoms
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian G Harbrecht, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing neuropsychologic testing in people with Traumatic Brain Injury and Trauma, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
functional outcome. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2008.