Status:
COMPLETED
Detection of Hemodynamic Changes in TBI Population With Functional Near Infrared Spectroscopy
Lead Sponsor:
Uniformed Services University of the Health Sciences
Collaborating Sponsors:
Center for Neuroscience and Regenerative Medicine (CNRM)
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
18-60 years
Brief 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 administr...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2015
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01797549
Start Date
January 1 2013
End Date
December 31 2015
Last Update
January 17 2019
Active Locations (1)
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1
Center for Neuroscience and Regenerative Medicine (CNRM)
Rockville, Maryland, United States, 20851