Cerebral Small Vessel DiseasesNCT02890888
Effect of Hyperbaric Oxygen on Functional Connectivity in Patients With Cerebral Small Vessel Disease
A study testing hyperbaric oxygen treatment in people with Cerebral Small Vessel Diseases, run by St. Luke's Hospital, Chesterfield, Missouri at 3 sites in United States.
Trial summary
Patients will have a Functional MRI before and after 10 hyperbaric Oxygen treatments. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Cerebral Small Vessel Diseases
- What is being tested?
- hyperbaric oxygen treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2014to 25 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- White Matter Hyperintensities on MRI
- 2 or more neurological symptoms or impairments e.g. gait disturbances, disequilibrium, cognitive decline, dysmetria, hyper-rflexia
Who cannot join
- 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%)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
St. Luke's hospital
Chesterfield, Missouri, 63017
St. Luke's Hospital
St Louis, Missouri, 63017
Mallinckrodt Institute of Radiology/Washington University Medical School
St Louis, Missouri, 63110
About this study
Official title: The Effect of Hyperbaric Oxygen on the Functional Connectivity of Resting State Neural Networks in Patients With Cerebral Small Vessel Disease
Patients will have a Functional MRI before and after 10 hyperbaric Oxygen treatments.
Read the 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.
- Conditions
- Cerebral Small Vessel Diseases
- Being tested
- hyperbaric oxygen treatment
- Keywords
- small vessel disease of the brain, hyperbaric oxygen, functional connectivity MRI
- Medical subject headings
- Cerebral Small Vessel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hyperbaric oxygen treatmentOther
Patients are treated in a hyperbaric oxygen chamber for 1 hour at 2ATA, 10 times over 2 consecutive weeks, 5 times per week
| Study group | Role | What they receive |
|---|---|---|
| Hyperbaric oxygen treatment | Experimental | HBO for 1 hour at 2 ATA 10 times, administered 5 times per week over 2 consecutive weeks Receives: Other: hyperbaric oxygen treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change in baseline rsnfc before and 4 weeks after hyperbaric oxygen
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study startNov 2014
- Primary completion25 Oct 2017
- Study completion25 Oct 2017
Why it stopped: Depletion of Funds and Illness of principal investigator
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Small Vessel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Luke's Hospital, Chesterfield, Missouri
- Sponsor type
- University, hospital or other
- Collaborators
- Washington University School of Medicine
- Responsible party
- Principal investigator, John Davidson, St. Luke's Hospital, Chesterfield, Missouri
- Investigators
- John D. Davidson, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02890888
- Sponsor's protocol ID
- 2014.011
- Status last verified
- Oct 2017
- First submitted
- 5 Sep 2014
- Last updated
- 27 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hyperbaric Oxygen on the Functional Connectivity of Resting State Neural Networks in Patients With Cerebral Small Vessel Disease
- ClinicalTrials.gov ID
- NCT02890888
- Acronym / sponsor ID
- 2014.011
- Conditions
- Cerebral Small Vessel Diseases
- Keywords
- small vessel disease of the brain, hyperbaric oxygen, functional connectivity MRI
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Depletion of Funds and Illness of principal investigator
- Enrolment
- 6 participants (actual)
- Lead sponsor
- St. Luke's Hospital, Chesterfield, MissouriUniversity, hospital or other
- Collaborators
- Washington University School of Medicine
- Study start
- Nov 2014
- Primary completion
- 25 Oct 2017 (actual)
- Study completion
- 25 Oct 2017 (actual)
- First posted
- 7 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hyperbaric oxygen treatment | Experimental | Other: hyperbaric oxygen treatmentHBO for 1 hour at 2 ATA 10 times, administered 5 times per week over 2 consecutive weeks |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- White Matter Hyperintensities on MRI
- 2 or more neurological symptoms or impairments e.g. gait disturbances, disequilibrium, cognitive decline, dysmetria, hyper-rflexia
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hyperbaric oxygen treatmentPatients are treated in a hyperbaric oxygen chamber for 1 hour at 2ATA, 10 times over 2 consecutive weeks, 5 times per week | Other | Hyperbaric oxygen treatment |
Primary outcome
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.
Time frame: Change in baseline rsnfc before and 4 weeks after hyperbaric oxygen
Functional connectivity MRI of resting state neural networks.
Results and safety
The study was stopped early (reason given: Depletion of Funds and Illness of principal investigator). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John D. Davidson, MD principal investigator
Washington University School of Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hyperbaric oxygen treatment in people with Cerebral Small Vessel Diseases, run by St. Luke's Hospital, Chesterfield, Missouri at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Depletion of Funds and Illness of principal investigator). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Change in baseline rsnfc before and 4 weeks after hyperbaric oxygen). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2017.