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

Encephalopathy Clinical Trial

— HBO  

Official title:

The Effect of Hyperbaric Oxygen on the Functional Connectivity of Resting State Neural Networks in Patients With Cerebral Small Vessel Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02232958
• Other study ID #: IRB #2014.011
• Status: Terminated
• Phase: N/A
• First received: September 3, 2014
• Last updated: October 26, 2017
• Start date: September 16, 2014
• Est. completion date: October 4, 2017

Study information

• Verified date: October 2017
• Source: St. Luke's Hospital, Chesterfield, Missouri
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: October 4, 2017
• Est. primary completion date: May 24, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Diseases
• Cerebral Small Vessel Diseases
• Encephalopathy
• Impaired Oxygen Delivery
• White Matter Hyperintensities

Intervention

Other:
• Hyperbaric Oxygen Treatment
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.

Locations

Country	Name	City	State
United States	St. Luke's Hospital	Chesterfield	Missouri
United States	Mallinckrodt Institute of Radiology/Washington University Medical School	Saint Louis	Missouri
United States	St. Luke's Hospital	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
St. Luke's Hospital, Chesterfield, Missouri	Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	4-6 weeks