Measure of Cerebrovascular Dysfunction After TBI With fNIRS

Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01789164
• Other study ID #: G189AP-S2
• Status: Completed
• Start date: January 2013
• Est. completion date: December 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

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Post-Concussion Syndrome
• 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 (2)

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.

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The degree of CVR disruption correlates with the severity of TBI or post-concussive symptoms		Two years
Primary	Reproducibility of CVR measurements with fNIRS during intersession and intra-session testing	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	Examine the following hypothesis: TBI subjects have a lower CVR compared to healthy controls		Two years