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

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02890888

Enrollment

Registered

2016-09-07

Start date

2014-11-30

Completion date

2017-10-25

Last updated

2017-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Small Vessel Diseases

Keywords

small vessel disease of the brain, hyperbaric oxygen, functional connectivity MRI

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.

Interventions

OTHERhyperbaric 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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to 90 Years

Healthy volunteers

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%)

Design outcomes

Primary

Measure	Time frame	Description
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.	Change in baseline rsnfc before and 4 weeks after hyperbaric oxygen	Functional connectivity MRI of resting state neural networks.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026