Study Stopped
Depletion of Funds and Illness of principal investigator
Effect of Hyperbaric Oxygen on Functional Connectivity in Patients With Cerebral Small Vessel Disease
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
6
1 country
3
Brief Summary
Patients will have a Functional MRI before and after 10 hyperbaric Oxygen treatments.
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 Nov 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 5, 2014
CompletedStudy Start
First participant enrolled
November 1, 2014
CompletedFirst Posted
Study publicly available on registry
September 7, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 25, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 25, 2017
CompletedOctober 27, 2017
October 1, 2017
3 years
September 5, 2014
October 25, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in average functional connectivity (fc) within the Default Mode Network and the Dorsal Attention Network will be obtained by resting state network (rsn) functional connectivity (rsnfc) MRI.
Functional connectivity MRI of resting state neural networks.
Change in baseline rsnfc before and 4 weeks after hyperbaric oxygen
Study Arms (1)
Hyperbaric oxygen treatment
EXPERIMENTALHBO for 1 hour at 2 ATA 10 times, administered 5 times per week over 2 consecutive weeks
Interventions
Patients are treated in a hyperbaric oxygen chamber for 1 hour at 2ATA, 10 times over 2 consecutive weeks, 5 times per week
Eligibility Criteria
You may qualify if:
- White Matter Hyperintensities on MRI
- or more neurological symptoms or impairments e.g. gait disturbances, disequilibrium, cognitive decline, dysmetria, hyper-rflexia
You may not qualify if:
- Contraindication to hyperbaric oxygen treatment e.g. pulmonary emphysema, seizure disorder
- major eustachian tube dysfunction
- stroke with previous 6 months
- extreme cognitive impairment
- major depression
- history of migraine, electroshock therapy, brain irradiation, brain tumor, head trauma
- other uncontrolled co-morbidities, e.g. diabetes, renal or hepatic dysfunction, hypertension, thyroid disorders, carotid artery stenosis (\>70%)
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
Washington University School of Medicine
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
- Director, Division of Hyperbaric Medicine
Study Record Dates
First Submitted
September 5, 2014
First Posted
September 7, 2016
Study Start
November 1, 2014
Primary Completion
October 25, 2017
Study Completion
October 25, 2017
Last Updated
October 27, 2017
Record last verified: 2017-10
Data Sharing
- IPD Sharing
- Will not share