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

Cerebral Small Vessel Diseases Clinical Trial

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: NCT02890888
• Other study ID #: 2014.011
• Status: Terminated
• Phase: N/A
• First received: September 5, 2014
• Last updated: October 25, 2017
• Start date: November 2014
• Est. completion date: October 25, 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

Patients will have a Functional MRI before and after 10 hyperbaric Oxygen treatments.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: October 25, 2017
• Est. primary completion date: October 25, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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%)

Related Conditions & MeSH terms

• Cerebral Small Vessel Diseases

Intervention

Other:
• hyperbaric oxygen treatment
Patients are treated in a hyperbaric oxygen chamber for 1 hour at 2ATA, 10 times over 2 consecutive weeks, 5 times per week

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	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