Measure of Cerebrovascular Dysfunction After TBI With fNIRS
| Status: | Completed |
|---|---|
| Conditions: | Hospital, Neurology |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 1/19/2019 |
| Start Date: | January 2013 |
| End Date: | December 2015 |
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.
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.
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.
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.
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)
We found this trial at
1
site
Rockville, Maryland 20851
Principal Investigator: Ramon Diaz-Arrastia, MD, PhD
Phone: 301-295-6420
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