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Effect of HBO on Functional Connectivity of Resting State Networks in Patients With Cerebral Small Vessel Disease (HBO)

Primary Purpose

Encephalopathy, White Matter Hyperintensities, Impaired Oxygen Delivery

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Hyperbaric Oxygen Treatment

About this trial

This is an interventional treatment trial for Encephalopathy focused on measuring Hyperbaric Oxygen, Small Vessel Disease of the Brain, Impaired Brain Circuit Connections

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Exclusion Criteria: Contraindications to hyperbaric oxygen therapy e.g. pulmonary emphysema or bullae, claustrophobiia, seizure diorder Inability of the patient to tolerate pressurization e.g. Eustachian tube dysfunction Stroke within the previous 6 months Extreme cognitive impairment Major depression Other uncontrolled co-morbidities, e.g. diabetes, hypertension, thyroid disorders, carotid artery stenosis (>70%), renal or hepatic dysfunction History of brain tumor, head trauma, electric shock therapy, brain irradiation History of migraine headaches

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

administration of 100% Oxygen at 2 Atmospheres Absolute for 1 hour 1 daily, 5 days a week for 2 weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

an improvement on the NIH Neurobehavioral scale compared to the one done before hyperbaric oxygen

NIH Neurobehavioral evaluations be obtained 4-6 weeks after exposure to 10 hyperbaric oxygen sessions of 1 hour at 2 atmospheres delivered over a period of 2 weeks. These will be compared to evaluations obtained prior to hyperbaric oxygen treatment.

Full Information

NCT ID

NCT02232958

First Posted

September 3, 2014

Last Updated

October 26, 2017

Sponsor

St. Luke's Hospital, Chesterfield, Missouri

Collaborators

Washington University School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT02232958

Brief Title

Effect of HBO on Functional Connectivity of Resting State Networks in Patients With Cerebral Small Vessel Disease

Acronym

HBO

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

Funds depleted and Ilness of Principal Investigator

Study Start Date

September 16, 2014 (Actual)

Primary Completion Date

May 24, 2016 (Actual)

Study Completion Date

October 4, 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

5. Study Description

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.

Detailed Description

Patients without contraindications to Hyperbaric Oxygen treatment or magnetic resonance imaging who exhibit white matter hyper-intensities on MRI will be recruited to have a functional MRI followed by10 hyperbaric oxygen treatments at 2 ATA for one hour. These treatments will be done once daily, from Monday through Friday, on 2 consecutive weeks. 4-6 weeks later, they have a repeat fMRI. These fMRI's will be analyzed regarding any changes in the resting state connectivity of various circuits.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Encephalopathy, White Matter Hyperintensities, Impaired Oxygen Delivery

Keywords

Hyperbaric Oxygen, Small Vessel Disease of the Brain, Impaired Brain Circuit Connections

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Hyperbaric Oxygen treatment

Arm Type

Experimental

Arm Description

administration of 100% Oxygen at 2 Atmospheres Absolute for 1 hour 1 daily, 5 days a week for 2 weeks

Intervention Type

Other

Intervention Name(s)

Hyperbaric Oxygen Treatment

Intervention Description

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.

Primary Outcome Measure Information:

Title

Evidence of an increase in the connectivity of resting state neural networks after treatment with hyperbaric oxygen

Description

Time Frame

4-6 weeks after treatment

Secondary Outcome Measure Information:

Title

an improvement on the NIH Neurobehavioral scale compared to the one done before hyperbaric oxygen

Description

Time Frame

4-6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Over 50 years of age White Matter Hyperintensities on MRI @ or more symptoms and/or neurological impairments e.g. gait disturbances,disequilibrium, decline in cognitive function, upper motor neuron deficit, dysmetria, hyper-refexia or unilateral increase in motor tone - Exclusion Criteria: Contraindications to hyperbaric oxygen therapy e.g. pulmonary emphysema or bullae, claustrophobiia, seizure diorder Inability of the patient to tolerate pressurization e.g. Eustachian tube dysfunction Stroke within the previous 6 months Extreme cognitive impairment Major depression Other uncontrolled co-morbidities, e.g. diabetes, hypertension, thyroid disorders, carotid artery stenosis (>70%), renal or hepatic dysfunction History of brain tumor, head trauma, electric shock therapy, brain irradiation History of migraine headaches -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John D. Davidson, MD

Organizational Affiliation

St. Luke's Hospital St. Louis & Washington University Medical School

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

Learn more about this trial

Effect of HBO on Functional Connectivity of Resting State Networks in Patients With Cerebral Small Vessel Disease

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