Effect of Hyperbaric Oxygen on Functional Connectivity in Patients With Cerebral Small Vessel Disease

Study Overview
=================
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.

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

Conditions
-----------------
Cerebral Small Vessel Diseases

Intervention / Treatment
-----------------
* Other: hyperbaric oxygen treatment


Participation Criteria
=================
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%)

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hyperbaric oxygen treatment<br>HBO for 1 hour at 2 ATA 10 times, administered 5 times per week over 2 consecutive weeks | Other: hyperbaric oxygen treatment<br>* Patients are treated in a hyperbaric oxygen chamber for 1 hour at 2ATA, 10 times over 2 consecutive weeks, 5 times per week<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
small vessel disease of the brain, hyperbaric oxygen, functional connectivity MRI