Study Stopped
Funds depleted and Ilness of Principal Investigator
Effect of HBO on Functional Connectivity of Resting State Networks in Patients With Cerebral Small Vessel Disease
HBO
The Effect of Hyperbaric Oxygen on the Functional Connectivity of Resting State Neural Networks in Patients With Cerebral Small Vessel Disease
1 other identifier
interventional
20
1 country
3
Brief Summary
The purpose of this study is to extend our previous work, in which we demonstrated an increase in the internal and cross network connectivity of resting state neural networks in patients with cerebral small vessel disease by treatment with hyperbaric oxygen, to at least 20 more individuals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2014
Typical duration for not_applicable
3 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
First Submitted
Initial submission to the registry
September 3, 2014
CompletedFirst Posted
Study publicly available on registry
September 5, 2014
CompletedStudy Start
First participant enrolled
September 16, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 24, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 4, 2017
CompletedOctober 30, 2017
October 1, 2017
1.7 years
September 3, 2014
October 26, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evidence of an increase in the connectivity of resting state neural networks after treatment with hyperbaric oxygen
Patients with small vessel disease of the brain will be treated with 10 hyperbaric oxygen sessions for 1 hour at 2 atmospheres absolute over the course of 2 weeks. Functional connectivity MRIs will be obtained 4-6 weeks after these sessions for comparison with those obtained before hyperbaric oxygen exposure
4-6 weeks after treatment
Secondary Outcomes (1)
an improvement on the NIH Neurobehavioral scale compared to the one done before hyperbaric oxygen
4-6 weeks
Study Arms (1)
Hyperbaric Oxygen treatment
EXPERIMENTALadministration of 100% Oxygen at 2 Atmospheres Absolute for 1 hour 1 daily, 5 days a week for 2 weeks
Interventions
Patients are placed in a special chamber in which the pressure is gradually increased up to the desired pressure with 100% Oxygen and the patient is kept at that pressure for one hour. Then the Oxygen flow is slowly reduced until the patient has been returned to one atmosphere of pressure.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
St. Luke's Hospital
Chesterfield, Missouri, 63017, United States
St. Luke's Hospital
St Louis, Missouri, 63017, United States
Mallinckrodt Institute of Radiology/Washington University Medical School
St Louis, Missouri, 63110, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John D. Davidson, MD
St. Luke's Hospital St. Louis & Washington University Medical School
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Clinical Medicine Washington University School of Medicine
Study Record Dates
First Submitted
September 3, 2014
First Posted
September 5, 2014
Study Start
September 16, 2014
Primary Completion
May 24, 2016
Study Completion
October 4, 2017
Last Updated
October 30, 2017
Record last verified: 2017-10
Data Sharing
- IPD Sharing
- Will not share