- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01789164
Measure of Cerebrovascular Dysfunction After TBI With fNIRS
Measure of Cerebrovascular Dysfunction After Truamatic Brain Injury With Functional Near Infrared Spectroscopy
Study Overview
Status
Conditions
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Maryland
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Rockville, Maryland, United States, 20851
- Center for Neuroscience and Regenerative Medicine (CNRM)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- ALL participants (TBI and non-TBI) subjects Males and females, ages 18 to 60 years, inclusive Able to read, write, speak and understand English
- A history of TBI
- Persistent post-concussive symptoms, according to the DSM-IV Research
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:
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
- Known allergy to latex (used in the NIRS apparatus band applied to the forehead)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Healthy group
Healthy group with no history of TBI or concussion.
Gender matched non-TBI volunteers
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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
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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
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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.
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Two years
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Examine the following hypothesis: TBI subjects have a lower CVR compared to healthy controls
Time Frame: Two years
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Two years
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Other Outcome Measures
Outcome Measure |
Time Frame |
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The degree of CVR disruption correlates with the severity of TBI or post-concussive symptoms
Time Frame: Two years
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Two years
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Collaborators and Investigators
Publications and helpful links
General Publications
- Reddy P, Izzetoglu M, Shewokis PA, Sangobowale M, Diaz-Arrastia R, Izzetoglu K. Evaluation of fNIRS signal components elicited by cognitive and hypercapnic stimuli. Sci Rep. 2021 Dec 6;11(1):23457. doi: 10.1038/s41598-021-02076-7.
- Kenney K, Amyot F, Haber M, Pronger A, Bogoslovsky T, Moore C, Diaz-Arrastia R. Cerebral Vascular Injury in Traumatic Brain Injury. Exp Neurol. 2016 Jan;275 Pt 3:353-366. doi: 10.1016/j.expneurol.2015.05.019. Epub 2015 Jun 3.
- Assessment of Cerebrovascular Dysfunction after Traumatic Brain Injury: MRI-BOLD versus NIRS (S28.006) Franck Amyot, Kimbra Kenney, Carol Moore, Erika Silverman, Emily Spessert, Leah Harburg, Ramon Diaz-Arrastia Neurology Apr 2015, 84 (14 Supplement) S28.006;
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- G189AP-S2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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