Traumatic Brain InjuryNCT01797549
Detection of Hemodynamic Changes in TBI Population With Functional Near Infrared Spectroscopy
An observational study of Traumatic Brain Injury, run by Uniformed Services University of the Health Sciences at 1 site in United States.
Trial summary
The goal of this project is to develop a test to assess frontal lobe function using a rapid, inexpensive, objective, and standardized method, without the need for expertise in cognitive test administration. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to 31 Dec 2015
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult
Study population: Males and females (military health care beneficiaries and non military health care beneficiaries) age between 18 and 60 years who have a diagnosis of moderate or severe traumatic brain injury as well as age, gender, education matched non-TBI volunteers.
Who may be able to join
- Able to read, write, speak and understand English
- history of having sustained a TBI prior to enrollment. Evidence will be any one of the following 3 criteria:
- GCS 3 - 12
- Post-traumatic amnesia > 24 hours
- TBI-related abnormality on neuroimaging (either CT or MRI). (Some missing information about the initial injury (i.e. documentation of initial GCS) is not necessarily exclusionary if the bulk of the available history is indicative that the patient suffered a TBI and meets the inclusion criteria)
Who cannot join
- Multiple sclerosis, pre- or co-existing
- Stroke (other than stroke at the time of TBI)
- Pre-existing developmental disorder
- Pre-existing epilepsy
- Pre-existing major depressive disorder
- Pre-existing schizophrenia
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Neuroscience and Regenerative Medicine (CNRM)
Rockville, Maryland, 20851
About this study
The goal of this project is to develop a test to assess frontal lobe function using a rapid, inexpensive, objective, and standardized method, without the need for expertise in cognitive test administration. Such methods would be particularly helpful in traumatic brain injury (TBI), where objective measures are needed, and would greatly expand the capacity to make such assessments in clinical practice and research.
- Conditions
- Traumatic Brain Injury
- Keywords
- Traumatic brain injury, functional near infrared spectroscopy
- 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.
| Study group | Role | What they receive |
|---|---|---|
| History of having sustained TBI | Males and females between 18 and 60 years who have a diagnosis of TBI | |
| Control group | Control group with no history of TBI or concussion. Gender and age matched non-TBI volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of hemodynamic response function
In two population groups: TBI and non TBI, we will determine normative data for the cognitive parametric experiment by measuring the local hemodynamic response function with functional near infrared spectroscopy
Measured: Two years
Secondary outcomes (1)
Measure of the degree of impairment
Determine the relationship between hemodynamic response as measured by fNIRS and measures of neuropsychological and behavioral functioning obtained using measures from the NINDS Common Data Elements.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2013 (estimated)
- Study startJan 2013
- Primary completion31 Dec 2015
- Study completion31 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Uniformed Services University of the Health Sciences
- Sponsor type
- US federal agency
- Collaborators
- Center for Neuroscience and Regenerative Medicine (CNRM)
- Responsible party
- Principal investigator, Ramon Diaz-Arrastia, Uniformed Services University of the Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01797549
- Sponsor's protocol ID
- 0189AP
- Status last verified
- Jan 2019
- First submitted
- 7 Feb 2013
- Last updated
- 17 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Chernomordik V, Amyot F, Kenney K, Wassermann E, Diaz-Arrastia R, Gandjbakhche A. Abnormality of low frequency cerebral hemodynamics oscillations in TBI population. Brain Res. 2016 May 15;1639:194-9. doi: 10.1016/j.brainres.2016.02.018. Epub 2016 Mar 17.
PubMed 26996413
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Hemodynamic Changes in TBI Population With Functional Near Infrared Spectroscopy
- ClinicalTrials.gov ID
- NCT01797549
- Acronym / sponsor ID
- 0189AP
- Conditions
- Traumatic Brain Injury
- Keywords
- Traumatic brain injury, functional near infrared spectroscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Uniformed Services University of the Health SciencesUS federal agency
- Collaborators
- Center for Neuroscience and Regenerative Medicine (CNRM)
- Study start
- Jan 2013 (actual)
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 31 Dec 2015 (actual)
- First posted
- 22 Feb 2013 (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.
The goal of this project is to develop a test to assess frontal lobe function using a rapid, inexpensive, objective, and standardized method, without the need for expertise in cognitive test administration. Such methods would be particularly helpful in traumatic brain injury (TBI), where objective measures are needed, and would greatly expand the capacity to make such assessments in clinical practice and research.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| History of having sustained TBI | – | –Males and females between 18 and 60 years who have a diagnosis of TBI |
| Control group | – | –Control group with no history of TBI or concussion. Gender and age matched non-TBI volunteers |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Males and females (military health care beneficiaries and non military health care beneficiaries) age between 18 and 60 years who have a diagnosis of moderate or severe traumatic brain injury as well as age, gender, education matched non-TBI volunteers.
Key inclusion criteria (5 listed)
- Able to read, write, speak and understand English
- history of having sustained a TBI prior to enrollment. Evidence will be any one of the following 3 criteria:
Key exclusion criteria (6 listed)
- Multiple sclerosis, pre- or co-existing
- Stroke (other than stroke at the time of TBI)
- Pre-existing developmental disorder
- Pre-existing epilepsy
- Pre-existing major depressive disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measure of hemodynamic response function
Time frame: Two years
In two population groups: TBI and non TBI, we will determine normative data for the cognitive parametric experiment by measuring the local hemodynamic response function with functional near infrared spectroscopy
1 secondary outcome
Measure of the degree of impairment
Time frame: Two years
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 17 Jan 2019.
- Results publication: PubMed 26996413Chernomordik V, Amyot F, Kenney K, Wassermann E, Diaz-Arrastia R, Gandjbakhche A. Abnormality of low frequency cerebral hemodynamics oscillations in TBI population. Brain Res. 2016 May 15;1639:194-9. doi: 10.1016/j.brainres.2016.02.018. Epub 2016 Mar 17.
- Individual participant dataSharing planned: No
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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?
An observational study of Traumatic Brain Injury, run by Uniformed Services University of the Health Sciences 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 5 inclusion and 6 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 17 Jan 2019. 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?
Measure of hemodynamic response function (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01797549, which also lists 1 linked publication.
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 17 Jan 2019.