Functional and Anatomical Magnetic Resonance Imaging (MRI) of Chronic Brain Injury and Hyperbaric Oxygen (HBO2) Study Subjects "HYBOBI-MRI"

Completed

Phase 2 Results N/A

Trial Description

The purpose of this study is to evaluate Brain MRI (Magnetic Resonance Imaging), and Brain CT (Computed Tomography) Angiogram data in subjects who participate in the "Hyperbaric Oxygen for Chronic Stable Brain Injury" (HYBOBI) study. Including information from MRI and CT studies provide information about whether hyperbaric oxygen improves brain function in subjects who have had a brain injury. Subjects will complete MR and CT scans twice during the study. The first MR and CT will be performed prior to the first hyperbaric session of the HYBOBI study, and the second will be performed within two weeks following the last hyperbaric session.

Detailed Description

In an ongoing feasibility study (HYBOBI), brain-injured subjects are exposed to hyperbaric oxygen at 1.5 atmospheres for 60 minutes. They receive this exposure five days per week, and receive 60 total sessions. Prior to hyperbaric oxygen, these study subjects have neurologic, cognitive, and functional measures. The measures are repeated at the conclusion of 60 hyperbaric oxygen sessions, and again six months later. The goal of the HYBOBI feasibility study is to learn about these patients and determine possible hyperbaric oxygen effects, if any, to prepare for a blinded randomized controlled clinical trial.
This study adds an imaging component to the HYBOBI study, further investigating brain changes in participants. Participants will undergo Brain MRI (Magnetic Resonance Imaging) using a 3 tesla magnet, and Brain CT (Computed Tomography) Angiogram. Subjects will undergo imaging before receiving hyperbaric oxygen and within 2 weeks of completion of the 60 hyperbaric sessions.

Conditions

Interventions

  • Magnetic Resonance Imaging Diagnostic Test
    Other Names: MRI
    Intervention Desc: Imaging of the brain without gadolinium will be performed with a 3 Tesla magnetic resonance (MR) System (Intera Achieva 3T; Philips Medical Systems). The protocol will include anatomical sequences, a diffusion tensor imaging sequence with fiber tracking, and auditory, visual, and motor functional magnetic resonance imaging (MRI).
    ARM 1: Kind: Experimental
    Label: Hyperbaric oxygen
    Description: In this open-label feasibility study, all subjects will receive 60 hyperbaric oxygen sessions (100% oxygen, 1.5 atmospheres absolute (atm abs), for 60 minutes), delivered daily, five days per week.
  • Computed Tomography Angiography Procedure
    Other Names: CT; CTA
    Intervention Desc: Computed tomography angiography (CTA) with intravenous (IV) contrast will be performed on a 320 head computed tomography (CT) scanner, assessing brain perfusion.
    ARM 1: Kind: Experimental
    Label: Hyperbaric oxygen
    Description: In this open-label feasibility study, all subjects will receive 60 hyperbaric oxygen sessions (100% oxygen, 1.5 atmospheres absolute (atm abs), for 60 minutes), delivered daily, five days per week.

Trial Design

  • Observation: Cohort
  • Perspective: Prospective
  • Sampling: Non-Probability Sample

Trial Population

Adults with chronic brain injury who are enrolled in the HYBOBI study.

Outcomes

Type Measure Time Frame Safety Issue
Primary Auditory functional magnetic resonance imaging (fMRI) activation Within 2 weeks of final hyperbaric session No
Primary Computed tomography angiography (CTA) Brain Perfusion Within 2 weeks of the final hyperbaric session No
Secondary MRI Results Within 2 weeks of the final hyperbaric session No

Sponsors