Detection of Hemodynamic Changes in TBI Population With Functional Near Infrared Spectroscopy

Uniformed Services University (USU)

Status: Completed

Conditions: Traumatic Brain Injury

Study type: Observational

Funder types: Other U.S. Federal agency

Identifiers

NCT01797549

0189AP

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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:

  1. GCS 3 - 12
  2. Post-traumatic amnesia > 24 hours
  3. 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 criteria

• 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 design

50 participants in 2 patient groups

History of having sustained TBI

Description:

Males and females between 18 and 60 years who have a diagnosis of TBI

Control group

Description:

Control group with no history of TBI or concussion. Gender and age matched non-TBI volunteers