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

NCT01797549 | Completed

• 1 other identifier: 0189AP
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury

Keywords

Traumatic brain injury; functional near infrared spectroscopy

Outcome Measures

Primary Outcomes (1)

• 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

  Two years

Secondary Outcomes (1)

• Measure of the degree of impairment

  Two years

Study Arms (2)

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 Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Uniformed Services University of the Health Sciences: lead
• Center for Neuroscience and Regenerative Medicine (CNRM): collaborator

Study Sites (1)

Center for Neuroscience and Regenerative Medicine (CNRM)

Rockville, Maryland, 20851, United States

Location

Related Publications (1)

• Chernomordik V, Amyot F, Kenney K, Wassermann E, Diaz-Arrastia R, Gandjbakhche A. Abnormality of low frequency cerebral hemodynamics oscillations in TBI population. Brain Res. 2016 May 15;1639:194-9. doi: 10.1016/j.brainres.2016.02.018. Epub 2016 Mar 17.

  PMID: 26996413 RESULT

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 2 Years
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Clinical Research

Study Record Dates

• First Submitted: February 7, 2013
• First Posted: February 22, 2013
• Study Start: January 1, 2013
• Primary Completion: December 31, 2015
• Study Completion: December 31, 2015
• Last Updated: January 17, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)