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

This study is currently recruiting participants.
Verified December 2015 by Ramon Diaz-Arrastia, Uniformed Services University of the Health Sciences
Sponsor:
ClinicalTrials.gov Identifier:
NCT01797549
First Posted: February 22, 2013
Last Update Posted: January 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Center for Neuroscience and Regenerative Medicine (CNRM)
Information provided by (Responsible Party):
Ramon Diaz-Arrastia, Uniformed Services University of the Health Sciences
  Purpose
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.

Condition
Traumatic Brain Injury

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 2 Years
Official Title: Detection of Hemodynamic Changes in TBI Population With Functional Near Infrared Spectroscopy

Resource links provided by NLM:


Further study details as provided by Ramon Diaz-Arrastia, Uniformed Services University of the Health Sciences:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.


Estimated Enrollment: 50
Study Start Date: January 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
History of having sustained TBI
Males and females between 18 and 60 years who have a diagnosis of TBI
Control group
Control group with no history of TBI or concussion. Gender and age matched non-TBI volunteers

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Males and females (military health care beneficiaries and non military health care beneficiaries) age between 18 and 60 years who have a diagnosis of moderate or severe traumatic brain injury as well as age, gender, education matched non-TBI volunteers.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01797549


Locations
United States, Maryland
Center for Neuroscience and Regenerative Medicine (CNRM) Recruiting
Rockville, Maryland, United States, 20851
Contact: Kimbra Kenney, MD    301-295-6420    kimbra.kenney@usuhs.edu   
Principal Investigator: Ramon Diaz-Arrastia, MD, PhD         
Sponsors and Collaborators
Uniformed Services University of the Health Sciences
Center for Neuroscience and Regenerative Medicine (CNRM)
  More Information

Responsible Party: Ramon Diaz-Arrastia, Director of Clinical Research, Uniformed Services University of the Health Sciences
ClinicalTrials.gov Identifier: NCT01797549     History of Changes
Other Study ID Numbers: 0189AP
First Submitted: February 7, 2013
First Posted: February 22, 2013
Last Update Posted: January 1, 2016
Last Verified: December 2015

Keywords provided by Ramon Diaz-Arrastia, Uniformed Services University of the Health Sciences:
Traumatic brain injury
functional near infrared spectroscopy

Additional relevant MeSH terms:
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries