TerminatedNot Applicable

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

Stopped: Funds depleted and Ilness of Principal Investigator

United States20 participantsStarted 2014-09-16

Plain-language 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.

Who can participate

Age range

50 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 \-

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 4-6 weeks after treatment

Trial details

NCT IDNCT02232958

SponsorSt. Luke's Hospital, Chesterfield, Missouri

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-05-24

View on ClinicalTrials.gov More Encephalopathy trials

Who can participate

Age range

50 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.