Functional and Anatomical Magnetic Resonance Imaging (MRI) of Chronic Brain Injury and Hyperbaric Oxygen (HBO2) Study Subjects (HYBOBI-MRI)
27. juli 2020 oppdatert 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Observasjonsmessig
Registrering (Faktiske)
17
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Utah
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Salt Lake City, Utah, Forente stater, 84143
- LDS Hospital
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 80 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Adults with chronic brain injury who are enrolled in the HYBOBI study.
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / 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).
Andre navn:
Computed tomography angiography (CTA) with intravenous (IV) contrast will be performed on a 320 head computed tomography (CT) scanner, assessing brain perfusion.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Auditory functional magnetic resonance imaging (fMRI) activation
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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MRI Results
Tidsramme: Within 2 weeks of the final hyperbaric session
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Within 2 weeks of the final hyperbaric session
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Susan K Churchill, APRN-NP, Intermountain Health Care, Inc.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. juli 2007
Primær fullføring (Faktiske)
1. juni 2010
Studiet fullført (Faktiske)
1. juni 2010
Datoer for studieregistrering
Først innsendt
1. mars 2010
Først innsendt som oppfylte QC-kriteriene
18. mai 2010
Først lagt ut (Anslag)
19. mai 2010
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
29. juli 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
27. juli 2020
Sist bekreftet
1. juli 2020
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 1004120
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