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

Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01797549
• Other study ID #: 0189AP
• Status: Completed
• Start date: January 2013
• Est. completion date: December 31, 2015

Study information

• Verified date: January 2019
• Source: Uniformed Services University of the Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 31, 2015
• Est. primary completion date: December 31, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury

Locations

Country	Name	City	State
United States	Center for Neuroscience and Regenerative Medicine (CNRM)	Rockville	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Uniformed Services University of the Health Sciences	Center for Neuroscience and Regenerative Medicine (CNRM)

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Measure of the degree of impairment	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.	Two years