Traumatic Brain Injury (TBI)TEAM-TBINCT02657135
Targeted Evaluation, Action, & Monitoring of Traumatic Brain Injury
A study testing Cognitive/Neuropsychological Testing, Vestibular/Ocular-Motor Testing and Cervical (Neck) Evaluation in people with Traumatic Brain Injury (TBI), run by University of Pittsburgh at 1 site in United States.
Trial summary
TEAM-TBI (Targeted Evaluation, Action, and Monitoring of Traumatic Brain Injury) is a research study that brings together TBI patients, advanced evaluation methods, and experts in a multi-faceted study to address the heterogeneity of TBI and to evaluate the effects self-help strategies might have on TBI outcomes. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Traumatic Brain Injury (TBI)
- What is being tested?
- Cognitive/Neuropsychological Testing, Vestibular/Ocular-Motor Testing and Cervical (Neck) Evaluation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2014to 23 Mar 2018
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18-60 years of age
- Fluent in English
- Documented history of TBI or blast exposure since 2001
Who cannot join
- Inability to have MRI
- Pregnancy
- History of TIA within last 6 months.
- Presently involved in open litigation
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Neurotrauma Clinical Trials Center
Pittsburgh, Pennsylvania, 15213
About this study
TEAM-TBI (Targeted Evaluation, Action, and Monitoring of Traumatic Brain Injury) is a research study that brings together TBI patients, advanced evaluation methods, and experts in a multi-faceted study to address the heterogeneity of TBI and to evaluate the effects self-help strategies might have on TBI outcomes.
Read the detailed description
TEAM-TBI (Targeted Evaluation, Action, and Monitoring of Traumatic Brain Injury) proposes a new approach to clinical trials in TBI that will:
- Evolve diagnostic technology \& treatment
- Improve self-help strategies
- Lower cost and speed for delivery of effective strategies
The TEAM-TBI program proposes an innovative new approach to TBI clinical trials to overcome the limitations of past efforts and achieve long-awaited breakthroughs for TBI survivors. The study will involve a comprehensive 3-4 day intake evaluation, followed by a variety of remotely performed tasks during a 1-6 month follow-up period.
- Conditions
- Traumatic Brain Injury (TBI)
- Being tested
- Cognitive/Neuropsychological Testing, Vestibular/Ocular-Motor Testing, Cervical (Neck) Evaluation, Sleep Evaluation, HDFT MRI
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive/Neuropsychological TestingBehavioural
These tests will be used to determine how the participant will continue with future procedures, and depending on results, may involve the participant returning to complete subsequent testing.
Vestibular/Ocular-Motor TestingOther
These assessments will involve a series of tests and questionnaires that focus on physical symptoms of TBI and will include dizziness, balance, ocular-motor coordination, and reflexes.
Cervical (Neck) EvaluationOther
These assessments will involve a series of tests and questionnaires that focus on physical symptoms of TBI including neck mobility and pain levels.
Sleep EvaluationOther
These evaluations will focus on assessing insomnia (duration, frequency, daytime consequences), combat exposure, and the presence and severity of trauma history.
HDFT MRIOther
This MRI aims at providing qualitative and quantitative assessments of the nature, location, and extent of white matter injury.
MR Spectroscopy (MRS)Other
This is a noninvasive diagnostic test for measuring biochemical changes in the brain.
MEG (Magnetoencephalography)Other
This is a non-invasive neurophysiological technique that measures the magnetic fields generated by neuronal activity of the brain.
| Study group | Role | What they receive |
|---|---|---|
| History of Traumatic Brain Injury | Experimental | All participants have a history of TBI. At study outcome participants are provided treatment recommendations that are the result of a consensus meeting of all physician investigators. Follow up care is not provided by this clinical trial. Receives: Behavioral: Cognitive/Neuropsychological Testing; Other: Vestibular/Ocular-Motor Testing; Other: Cervical (Neck) Evaluation; Other: Sleep Evaluation; Other: HDFT MRI; Other: MR Spectroscopy (MRS); Other: MEG (Magnetoencephalography) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The main outcome variable in the study will be the change in Post-Concussion Symptom Scale (PCSS) score from the initial intake evaluation compared to last follow-up evaluation.
Measured: Up to 6 months
Secondary outcomes (1)
Change in the Satisfaction with Life Scale
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2016 (estimated)
- Study start24 Mar 2014
- Primary completion23 Mar 2018
- Study completion23 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain Injury (TBI)Studies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, David Okonkwo, MD, Phd, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02657135
- Sponsor's protocol ID
- W81XWH-14-2-0002
- Acronym
- TEAM-TBI
- Status last verified
- Jul 2018
- First submitted
- 16 Jul 2015
- Last updated
- 23 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Evaluation, Action, & Monitoring of Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT02657135
- Acronym / sponsor ID
- TEAM-TBI / W81XWH-14-2-0002
- Conditions
- Traumatic Brain Injury (TBI)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 24 Mar 2014 (actual)
- Primary completion
- 23 Mar 2018 (actual)
- Study completion
- 23 Mar 2018 (actual)
- First posted
- 15 Jan 2016 (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.
TEAM-TBI (Targeted Evaluation, Action, and Monitoring of Traumatic Brain Injury) is a research study that brings together TBI patients, advanced evaluation methods, and experts in a multi-faceted study to address the heterogeneity of TBI and to evaluate the effects self-help strategies might have on TBI outcomes.
Detailed description
TEAM-TBI (Targeted Evaluation, Action, and Monitoring of Traumatic Brain Injury) proposes a new approach to clinical trials in TBI that will:
- Evolve diagnostic technology \& treatment
- Improve self-help strategies
- Lower cost and speed for delivery of effective strategies
The TEAM-TBI program proposes an innovative new approach to TBI clinical trials to overcome the limitations of past efforts and achieve long-awaited breakthroughs for TBI survivors. The study will involve a comprehensive 3-4 day intake evaluation, followed by a variety of remotely performed tasks during a 1-6 month follow-up period.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| History of Traumatic Brain Injury | Experimental | Behavioral: Cognitive/Neuropsychological Testing, Other: Vestibular/Ocular-Motor Testing, Other: Cervical (Neck) Evaluation, Other: Sleep Evaluation, Other: HDFT MRI, Other: MR Spectroscopy (MRS), Other: MEG (Magnetoencephalography)All participants have a history of TBI. At study outcome participants are provided treatment recommendations that are the result of a consensus meeting of all physician investigators. Follow up care is not provided by this clinical trial. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18-60 years of age
- Fluent in English
- Documented history of TBI or blast exposure since 2001
Key exclusion criteria (4 listed)
- Inability to have MRI
- Pregnancy
- History of TIA within last 6 months.
- Presently involved in open litigation
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 |
|---|---|---|
| Cognitive/Neuropsychological TestingThese tests will be used to determine how the participant will continue with future procedures, and depending on results, may involve the participant returning to complete subsequent testing. | Behavioural | History of Traumatic Brain Injury |
| Vestibular/Ocular-Motor TestingThese assessments will involve a series of tests and questionnaires that focus on physical symptoms of TBI and will include dizziness, balance, ocular-motor coordination, and reflexes. | Other | History of Traumatic Brain Injury |
| Cervical (Neck) EvaluationThese assessments will involve a series of tests and questionnaires that focus on physical symptoms of TBI including neck mobility and pain levels. | Other | History of Traumatic Brain Injury |
| Sleep EvaluationThese evaluations will focus on assessing insomnia (duration, frequency, daytime consequences), combat exposure, and the presence and severity of trauma history. | Other | History of Traumatic Brain Injury |
| HDFT MRIThis MRI aims at providing qualitative and quantitative assessments of the nature, location, and extent of white matter injury. | Other | History of Traumatic Brain Injury |
| MR Spectroscopy (MRS)This is a noninvasive diagnostic test for measuring biochemical changes in the brain. | Other | History of Traumatic Brain Injury |
| MEG (Magnetoencephalography)This is a non-invasive neurophysiological technique that measures the magnetic fields generated by neuronal activity of the brain. | Other | History of Traumatic Brain Injury |
Primary outcome
The main outcome variable in the study will be the change in Post-Concussion Symptom Scale (PCSS) score from the initial intake evaluation compared to last follow-up evaluation.
Time frame: Up to 6 months
1 secondary outcome
Change in the Satisfaction with Life Scale
Time frame: Up to 6 months
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 23 Jul 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive/Neuropsychological Testing, Vestibular/Ocular-Motor Testing and Cervical (Neck) Evaluation in people with Traumatic Brain Injury (TBI), 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 23 Jul 2018. 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?
The main outcome variable in the study will be the change in Post-Concussion Symptom Scale (PCSS) score from the initial intake evaluation compared to last follow-up evaluation. (time frame: Up to 6 months). 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 23 Jul 2018.