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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01797549

Enrollment

Registered

2013-02-22

Start date

2013-01-31

Completion date

2015-12-31

Last updated

2019-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Brain Injury

Keywords

Traumatic brain injury, functional near infrared spectroscopy

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 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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Measure of hemodynamic response function	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

Secondary

Measure	Time frame	Description
Measure of the degree of impairment	Two years	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.

Countries

United States

Outcome results