Skip to main content
OpenTrials
Completed

NCT Number: NCT01797549

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Center for Neuroscience and Regenerative Medicine (CNRM)

Rockville, Maryland, 20851, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:
  • 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 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

Treatment and study plan

Primary outcomes

  1. Measure of hemodynamic response function

    Time frame: 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 outcomes

  1. Measure of the degree of impairment

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Uniformed Services University of the Health Sciences

Fed

Collaborators

  • Center for Neuroscience and Regenerative Medicine (CNRM)

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Feb 22, 2013
Registry last updated
Jan 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.