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

Completed

• Conditions: Traumatic Brain Injury

• Registration Number: NCT01797549
• Lead Sponsor: Uniformed Services University of the Health Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-02-07
• Study First Submitted QC: 2013-02-20
• Study First Posted: 2013-02-22
• Primary Completion: 2015-12-31
• Study Completion: 2015-12-31
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-15
• Last Update Posted: 2019-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measure of hemodynamic response function	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

Name	Time	Method
Measure of the degree of impairment	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.

Trial Locations

Locations (1)

Center for Neuroscience and Regenerative Medicine (CNRM); 🇺🇸 Rockville, Maryland, United States