Functional and Anatomical Magnetic Resonance Imaging (MRI) of Chronic Brain Injury and Hyperbaric Oxygen (HBO2) Study Subjects (HYBOBI-MRI)
27 juli 2020 uppdaterad av: Lindell Weaver, Intermountain Health Care, Inc.
MRI & CT Angiogram and Hyperbaric Oxygen in Chronic Stable Brain Injury
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Faktisk)
17
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Utah
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Salt Lake City, Utah, Förenta staterna, 84143
- LDS Hospital
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 80 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Adults with chronic brain injury who are enrolled in the HYBOBI study.
Beskrivning
Inclusion Criteria:
- Subject has had a brain injury > 12 months
- Subject is >18 years old
Etiology of brain injury:
- stroke
- carbon monoxide
- anoxia
- trauma
- Must be able to equalize ears, or have tympanostomy tubes
- Willingness to complete outcome measures and comply with the research protocols
- Commitment to pay the hospital for hyperbaric oxygen
- Subject is enrolled in Hyperbaric Oxygen and Chronic Stable Brain Injury study-clinical trials government ID# NCT00830453.
Exclusion Criteria:
- Glasgow Coma Score <13 at the time of consent
- Poorly controlled seizures
- Inability to participate in outcome assessments (eg: blindness, quadraplegia); Claustrophobia
- Inability to equalize ears
- Inability to protect airway, or requiring frequent suctioning
- Tracheostomy
- Women of child-bearing potential or currently pregnant
- Severe psychiatric disorders
- Taking lithium
- Degenerative mental disease
- Chronic debilitating disease
- Heart failure with ejection fraction <50% or inability to lay supine
- Active malignancy, or prior treatment with cisplatin or bleomycin
- Current recreational drug use
- Consumption of more than the equivalent of 12 beers/week habitually
- Prior treatment with hyperbaric oxygen for chronic brain injury within the last year
- Implanted device that is a contra-indication to MRI
- Inability to travel to Las Vegas, either by car or by air
- Serum creatinine greater than the Intermountain Central Lab normal limit
- Unwillingness or inability to have intravenous contrast.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
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Hyperbaric oxygen
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.
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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).
Andra namn:
Computed tomography angiography (CTA) with intravenous (IV) contrast will be performed on a 320 head computed tomography (CT) scanner, assessing brain perfusion.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Auditory functional magnetic resonance imaging (fMRI) activation
Tidsram: Within 2 weeks of final hyperbaric session
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The first prime outcome measure will be auditory functional magnetic resonance imaging (fMRI) activation, comparing post-hyperbaric oxygen to pre-hyperbaric oxygen.
This is a categorical variable: absent, mild, moderate, normal, and increasing.
We will look at the difference between pre-hyperbaric (pre-HBO2) and post-hyperbaric (post-HBO2) scans graphically and descriptively, with the percentage of patients who show any improvement (any change towards normal).
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Within 2 weeks of final hyperbaric session
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Computed tomography angiography (CTA) Brain Perfusion
Tidsram: Within 2 weeks of the final hyperbaric session
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Pre-hyperbaric (pre-HBO2) computed tomography angiography (CTA) results will be determined to be normal or abnormal, and then compared to the post-hyperbaric (post-HBO2) scan, which will be scored as better, worse, or no change.
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Within 2 weeks of the final hyperbaric session
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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MRI Results
Tidsram: Within 2 weeks of the final hyperbaric session
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Within 2 weeks of the final hyperbaric session
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Susan K Churchill, APRN-NP, Intermountain Health Care, Inc.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 juli 2007
Primärt slutförande (Faktisk)
1 juni 2010
Avslutad studie (Faktisk)
1 juni 2010
Studieregistreringsdatum
Först inskickad
1 mars 2010
Först inskickad som uppfyllde QC-kriterierna
18 maj 2010
Första postat (Uppskatta)
19 maj 2010
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
29 juli 2020
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
27 juli 2020
Senast verifierad
1 juli 2020
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 1004120
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