Measure of Cerebrovascular Dysfunction After TBI With fNIRS

January 15, 2019 updated by: Ramon Diaz-Arrastia, Uniformed Services University of the Health Sciences

Measure of Cerebrovascular Dysfunction After Truamatic Brain Injury With Functional Near Infrared Spectroscopy

The goal of this project is to determine if it is possible to assess Cerebrovascular Reactivity (CVR) to hypercapnia with functional Near Infrared Spectroscopy (fNIRS). Such a method 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 standard clinical practice.

Study Overview

Status

Completed

Detailed Description

The prospective study design will consist of two study groups; the experimental group and the control group. In the Experimental Group (Group 1) we will enroll adult participants with TBI with persistent post-concussion symptoms or abnormalities on neuropsychological testing. In Group 2 we will enroll adult participants to serve as age and gender-matched healthy controls. Our goal is to recruit 100 subjects total in two groups of age and gender matched subjects, as follows: TBI (n = 50) and non-TBI (n = 50).

Participants in both groups will undergo NIRS testing with hypercapnia challenge, to measure the increase in hemodynamic flow signal during hypercapnia challenge via 2 methods, the breath holding and the Douglas bag methods. We will test intersessional validity of the NIRS-hypercapnia challenge in the first 20 (10 TBI and 10 non-TBI) subjects who are willing to return for a second visit of repeat testing.

The NIRS system is composed of 4 light sources and 10 detectors with a 16 point configuration system applied on the forehead of the subject. In our experiment, light intensity collected at each detector will be transformed into a signal related to the local concentrations of oxy- and de-oxyhemoglobin during the challenge. Each experiment will give a set of subject data, consisting of the peak amplitude and time-to-peak of the hemodynamic signals measured.

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Maryland
      • Rockville, Maryland, United States, 20851
        • Center for Neuroscience and Regenerative Medicine (CNRM)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Males and females (military health care beneficiaries and non military health care beneficiaries) between 18 and 60 years who have a diagnosis of TBI and are symptomatic with DSM-IV Research Criteria for Post-Concussional Disorder (see below), gender matched non-TBI volunteers.

Description

Inclusion Criteria:

  1. ALL participants (TBI and non-TBI) subjects Males and females, ages 18 to 60 years, inclusive Able to read, write, speak and understand English
  2. A history of TBI
  3. Persistent post-concussive symptoms, according to the DSM-IV Research
  4. Criteria for Post-Concussional Disorder, including:

    • Evidence from neuropsychological testing of difficulty in attention or memory. (refers to neuropsychological testing done as a part of the patient's hospital or rehabilitation care not as a part of screening for this study)
    • Three or more of the following symptoms, which started shortly after the trauma and persist for at least three months:

      • Fatigability
      • Disordered sleep
      • Headache
      • Vertigo or dizziness
      • Irritability or aggression
      • Anxiety, depression, or affective instability
      • Changes in personality (e.g. social or sexual inappropriateness)
      • Apathy or lack of spontaneity

Symptoms in criteria (a) and (b) must have their onset after trauma, or there was a significant worsening of pre-existing symptoms after trauma.

Exclusion Criteria:

  1. History or evidence of pre-existing neurological or psychiatric disorder not related to TBI, such as:

    • 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
  2. Known allergy to latex (used in the NIRS apparatus band applied to the forehead)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Healthy group
Healthy group with no history of TBI or concussion. Gender matched non-TBI volunteers
TBI group
Males and females between 18 and 60 years who have a diagnosis of TBI and are symptomatic with DSM-IV Research Criteria for Post-Concussional Disorder (see below), gender matched non-TBI volunteers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reproducibility of CVR measurements with fNIRS during intersession and intra-session testing
Time Frame: Two years
Establish reproducibility of CVR measurements with fNIRS during intersession and intra-session testing. Additionally, we will examine two methods of producing hypercapnia, breath holding and the Douglas bag methods to establish whether the two methods give similar NIRS results.
Two years

Secondary Outcome Measures

Outcome Measure
Time Frame
Examine the following hypothesis: TBI subjects have a lower CVR compared to healthy controls
Time Frame: Two years
Two years

Other Outcome Measures

Outcome Measure
Time Frame
The degree of CVR disruption correlates with the severity of TBI or post-concussive symptoms
Time Frame: Two years
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

February 7, 2013

First Submitted That Met QC Criteria

February 8, 2013

First Posted (Estimate)

February 11, 2013

Study Record Updates

Last Update Posted (Actual)

January 17, 2019

Last Update Submitted That Met QC Criteria

January 15, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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