Back to resultsEffect of Hyperbaric Oxygen on Functional Connectivity in Patients With Cerebral Small Vessel Disease
Primary Purpose
Cerebral Small Vessel Diseases
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
hyperbaric oxygen treatment
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Small Vessel Diseases focused on measuring small vessel disease of the brain, hyperbaric oxygen, functional connectivity MRI
Eligibility Criteria
Inclusion Criteria:
- White Matter Hyperintensities on MRI
- 2 or more neurological symptoms or impairments e.g. gait disturbances, disequilibrium, cognitive decline, dysmetria, hyper-rflexia
Exclusion Criteria:
- 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%)
Sites / Locations
- St. Luke's hospital
- St. Luke's Hospital
- Mallinckrodt Institute of Radiology/Washington University Medical School
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hyperbaric oxygen treatment
Arm Description
HBO for 1 hour at 2 ATA 10 times, administered 5 times per week over 2 consecutive weeks
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02890888
First Posted
September 5, 2014
Last Updated
October 25, 2017
Sponsor
St. Luke's Hospital, Chesterfield, Missouri
Collaborators
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02890888
Brief Title
Effect of Hyperbaric Oxygen on Functional Connectivity in Patients With Cerebral Small Vessel Disease
Official Title
The Effect of Hyperbaric Oxygen on the Functional Connectivity of Resting State Neural Networks in Patients With Cerebral Small Vessel Disease
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Terminated
Why Stopped
Depletion of Funds and Illness of principal investigator
Study Start Date
November 2014 (undefined)
Primary Completion Date
October 25, 2017 (Actual)
Study Completion Date
October 25, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Luke's Hospital, Chesterfield, Missouri
Collaborators
Washington University School of Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Patients will have a Functional MRI before and after 10 hyperbaric Oxygen treatments.
Detailed Description
Functional MRI studies will be done before and 4-6 weeks after Hyperbaric Oxygen treatment to assess changes in connectivity of resting state neural networks. 10 hyperbaric treatments at 2 atmospheres absolute for 1 hour at pressure will be administered. A review of symptoms and and thorough clinical neurological examination by an experienced neurologist familiar with these studies will be done before and 4-6 weeks after the hyperbaric treatments.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Small Vessel Diseases
Keywords
small vessel disease of the brain, hyperbaric oxygen, functional connectivity MRI
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hyperbaric oxygen treatment
Arm Type
Experimental
Arm Description
HBO for 1 hour at 2 ATA 10 times, administered 5 times per week over 2 consecutive weeks
Intervention Type
Other
Intervention Name(s)
hyperbaric oxygen treatment
Intervention Description
Patients are treated in a hyperbaric oxygen chamber for 1 hour at 2ATA, 10 times over 2 consecutive weeks, 5 times per week
Primary Outcome Measure Information:
Title
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.
Description
Functional connectivity MRI of resting state neural networks.
Time Frame
Change in baseline rsnfc before and 4 weeks after hyperbaric oxygen
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
White Matter Hyperintensities on MRI
2 or more neurological symptoms or impairments e.g. gait disturbances, disequilibrium, cognitive decline, dysmetria, hyper-rflexia
Exclusion Criteria:
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%)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John D. Davidson, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Luke's hospital
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
St. Luke's Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Mallinckrodt Institute of Radiology/Washington University Medical School
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Hyperbaric Oxygen on Functional Connectivity in Patients With Cerebral Small Vessel Disease
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