MRI Brain Changes Induced by Hyperbaric Oxygen Therapy in Brain Injury Patients
Brain Angiogenesis Induced by Hyperbaric Oxygen Therapy Can be Visualized by Perfusion MRI in Brain Injury Patients
1 other identifier
observational
30
1 country
2
Brief Summary
In our institute there is ongoing treatment of brain injury patients with Hyperbaric oxygen therapy. These patients undergo neuro-cognitive function tests in addition to brain imaging studies before and after treatment. The aim of this study was to evaluate the perfusion and microstructure changes seen in MRI in addition to the cognitive tests before and after the treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2015
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 15, 2015
CompletedFirst Posted
Study publicly available on registry
May 22, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedOctober 25, 2016
October 1, 2016
2.3 years
April 15, 2015
October 23, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Perfusion MRI changes
Before and after treatment. Treatment is approximately 3 months.
Microstructure changes (DTI)
Before and after treatment. Treatment is approximately 3 months.
Study Arms (1)
Brain trauma
Patients with chronic brain injury that have been treated with Hyperbaric oxygen therapy and underwent MRI imaging and cognitive tests before and after the treatment
Interventions
Eligibility Criteria
Retrospective analysis of patients suffering from chronic neuro-cognitive damage treated at Sagol center for hyperbaric medicine and research, Assaf Harofeh Medical Center, Israel from September 2013 . Patients included if they had at least two perfusion MRIs + DTI and two neurocognitive tests, before and after Hyperbaric Oxygen Therapy (HBOT). Treatment was approved by the institutional review board of the hospital.
You may qualify if:
- Patients included if they had at least two perfusion MRIs + DTI and two neurocognitive tests, before and after Hyperbaric Oxygen Therapy (HBOT).
You may not qualify if:
- did no complete treatment or did not complete examinations.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Assaf-Harofeh Medical Center
Ẕerifin, Israel, 70300, Israel
Assaf-Harofeh Medical Center
Ẕerifin, 70300, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr Sigal Tal
Study Record Dates
First Submitted
April 15, 2015
First Posted
May 22, 2015
Study Start
March 1, 2015
Primary Completion
June 1, 2017
Study Completion
June 1, 2017
Last Updated
October 25, 2016
Record last verified: 2016-10