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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2015-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Traumatic Brain Injury

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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History of having sustained TBI

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

No interventions assigned to this group

Control group

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

No interventions assigned to this group

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes