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

Uniformed Services University of the Health Sciences50 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Traumatic Brain Injury

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Center for Neuroscience and Regenerative Medicine (CNRM)

Rockville, Maryland, United States

Outcomes

Primary Outcomes

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

Time frame: Two years

Secondary Outcomes

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.

Time frame: Two years

Data from ClinicalTrials.gov

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