- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01126515
Functional and Anatomical Magnetic Resonance Imaging (MRI) of Chronic Brain Injury and Hyperbaric Oxygen (HBO2) Study Subjects (HYBOBI-MRI)
MRI & CT Angiogram and Hyperbaric Oxygen in Chronic Stable Brain Injury
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Utah
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Salt Lake City, Utah, États-Unis, 84143
- LDS Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
---|---|
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).
Autres noms:
Computed tomography angiography (CTA) with intravenous (IV) contrast will be performed on a 320 head computed tomography (CT) scanner, assessing brain perfusion.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Auditory functional magnetic resonance imaging (fMRI) activation
Délai: Within 2 weeks of final hyperbaric session
|
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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
MRI Results
Délai: Within 2 weeks of the final hyperbaric session
|
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Within 2 weeks of the final hyperbaric session
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Susan K Churchill, APRN-NP, Intermountain Health Care, Inc.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 1004120
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