Measure of Cerebrovascular Dysfunction After TBI With fNIRS

Completed

Conditions studied: Traumatic Brain Injury, Post-concussion Syndrome

In brief

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.

Key facts

Study ID

NCT01789164

Run by

Uniformed Services University of the Health Sciences

People needed

100

Starts

2013-01-01

Expected to finish

2015-12-01

Last updated by the study team

2019-01-17

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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)

Where it is running

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

Full record on ClinicalTrials.gov

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