Cerebral Cavernous MalformationNCT05298709
Functional Magnetic Resonance Imaging (fMRI) Vascular Reactivity in Cerebral Cavernous Malformations (CCM)
A study testing Hyperventilation and CO2 challenge in people with Cerebral Cavernous Malformation, run by University of New Mexico at 1 site in United States.
Trial summary
The goal is to characterize vascular reactivity and cardiac pulsatility of normal appearing white matter in patients with CCM during hypercarbia/hypocarbia using quantitative real-time high-speed multi-echo fMRI to develop prognostic biomarkers for CCM formation Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Cavernous Malformation
- What is being tested?
- Hyperventilation and CO2 challenge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2023to 17 Jul 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All familial CCM subjects presenting at UNMH who can consent to our study.
- Adult Male/Female patients ages >18 years old
Who cannot join
- Individuals ages <18 year
- Subjects with a known fear of dyspnea or enclosed spaces will be excluded from this study as well as those with metal implants, COPD, heart conditions, and hypercapnia.
- Subjects who have contraindications to MRI such as harboring incompatible ferromagnetic objects implanted in the body.
- Pregnant women (screening for pregnancy will be performed by oral questionnaire. MRI is safe in pregnancy but the study will exclude pregnant subjects, as the effects of respiratory challenge cannot be predicted in such subjects. Since these effects are proportional to the stage of gestation, oral history will be sufficient to assure safety.)
- Prisoners.
- People unable to consent.
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- People unable to participate due to prior neurological deficits.
- Subjects with underlying pre-existing pulmonary illness; such as asthma, COPD, pulmonary hypertension, will be excluded.
- Cognitively impaired and/or participants not able to speak English language will not be included in the study (This pilot study involves performing motor and verbal tasks while in the MRI, in addition to undergoing a respiratory challenge, that requires understanding instructions clearly. We do not have current capabilities to include a translator who would be available at all stages of the study to include subjects who do not speak English.)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico Neurology Research Center
Albuquerque, New Mexico, 87106
About this study
The goal is to characterize vascular reactivity and cardiac pulsatility of normal appearing white matter in patients with CCM during hypercarbia/hypocarbia using quantitative real-time high-speed multi-echo fMRI to develop prognostic biomarkers for CCM formation
- Conditions
- Cerebral Cavernous Malformation
- Being tested
- Hyperventilation and CO2 challenge
- Medical subject headings
- Hemangioma, Cavernous, Central Nervous System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperventilation and CO2 challengeOther
Subjects will also be asked to complete hyperventilation and CO2 breathing tasks based on instruction from the study investigators as described in study arm.
| Study group | Role | What they receive |
|---|---|---|
| Hypercarbia/Hypocarbia/resting state during fMRI | Experimental | During real time fMRI, all subjects will completed breathing tasks though a mask that supplies gas mixtures using the RespirAct™ Gas Control System (Thornhill Medical). The RespirAct™ is a computer-controlled gas blender providing carbon dioxide (CO2), oxygen (O2) and nitrogen for a subject to inhale while breathing for the purpose of controlling the concentrations of the respective blood gases.
For hypocarbia, subjects will be instructed to pace their breathing to 16- 20 breaths-per-minute to achieve a stable target end-tidal CO2 between 30 and 40 mm Hg.
Hypercarbia will be induced by increasing CO2 concentration and flow rate of the gas mixture until a desired ETCO2 level between 40 and 50 mm Hg has been reached.
There will also be a 10 minutes rest period during which respiratory rate and heart rate will be monitored continuously. Receives: Other: Hyperventilation and CO2 challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemodynamic Response
Primary end point of the study is to measure the amplitude and frequency response of hemodynamic response function during hypercarbia/hypocarbia using task-based functional MRI
Measured: 12 Months
Resting state connectivity
To measure the strength of resting-state connectivity during hypercarbia/hypocarbia using high-speed multi-echo resting-state functional MRI.
Measured: 12 month
Secondary outcomes (2)
Cardiac Pulsatility
Measure the amplitude and frequency spectrum of the cardiac pulsatility during hypercarbia/hypocarbia in functional MRI time series that are acquired using high-speed multi-echo functional MRI
Measured: 12 Months
First Harmonic
To measure the amplitude ratio of the first harmonic of the cardiac pulsatility relative to the cardiac base frequency in these data, which is a biomarker of vascular compliance.speed multi echo fMRI.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start15 Jun 2023
- Primary completion17 Jul 2024
- Study completion17 Jul 2024
Why it stopped: The study was determined to not be feasible at this time.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Cavernous MalformationStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05298709
- Sponsor's protocol ID
- 21-136
- Status last verified
- Jun 2025
- First submitted
- 9 Mar 2022
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There would not be any plans in place to share IPD. All data will be de-identified and not linked to any individual participant.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Magnetic Resonance Imaging (fMRI) Vascular Reactivity in Cerebral Cavernous Malformations (CCM)
- ClinicalTrials.gov ID
- NCT05298709
- Acronym / sponsor ID
- 21-136
- Conditions
- Cerebral Cavernous Malformation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was determined to not be feasible at this time.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Collaborators
- University of California, San Francisco
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 17 Jul 2024 (actual)
- Study completion
- 17 Jul 2024 (actual)
- First posted
- 28 Mar 2022 (actual)
- 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.
The goal is to characterize vascular reactivity and cardiac pulsatility of normal appearing white matter in patients with CCM during hypercarbia/hypocarbia using quantitative real-time high-speed multi-echo fMRI to develop prognostic biomarkers for CCM formation
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypercarbia/Hypocarbia/resting state during fMRI | Experimental | Other: Hyperventilation and CO2 challengeDuring real time fMRI, all subjects will completed breathing tasks though a mask that supplies gas mixtures using the RespirAct™ Gas Control System (Thornhill Medical). The RespirAct™ is a computer-controlled gas blender providing carbon dioxide (CO2), oxygen (O2) and nitrogen for a subject to inhale while breathing for the purpose of controlling the concentrations of the respective blood gases. For hypocarbia, subjects will be instructed to pace their breathing to 16- 20 breaths-per-minute to achieve a stable target end-tidal CO2 between 30 and 40 mm Hg. Hypercarbia will be induced by increasing CO2 concentration and flow rate of the gas mixture until a desired ETCO2 level between 40 and 50 mm Hg has been reached. There will also be a 10 minutes rest period during which respiratory rate and heart rate will be monitored continuously. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All familial CCM subjects presenting at UNMH who can consent to our study.
- Adult Male/Female patients ages >18 years old
Key exclusion criteria (9 listed)
- Individuals ages <18 year
- Subjects with a known fear of dyspnea or enclosed spaces will be excluded from this study as well as those with metal implants, COPD, heart conditions, and hypercapnia.
- Subjects who have contraindications to MRI such as harboring incompatible ferromagnetic objects implanted in the body.
- Pregnant women (screening for pregnancy will be performed by oral questionnaire. MRI is safe in pregnancy but the study will exclude pregnant subjects, as the effects of respiratory challenge cannot be predicted in such subjects. Since these effects are proportional to the stage of gestation, oral history will be sufficient to assure safety.)
- Prisoners.
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 |
|---|---|---|
| Hyperventilation and CO2 challengeSubjects will also be asked to complete hyperventilation and CO2 breathing tasks based on instruction from the study investigators as described in study arm. | Other | Hypercarbia/Hypocarbia/resting state during fMRI |
Primary outcome
Hemodynamic Response
Time frame: 12 Months
Primary end point of the study is to measure the amplitude and frequency response of hemodynamic response function during hypercarbia/hypocarbia using task-based functional MRI
Resting state connectivity
Time frame: 12 month
To measure the strength of resting-state connectivity during hypercarbia/hypocarbia using high-speed multi-echo resting-state functional MRI.
2 secondary outcomes
Cardiac Pulsatility
Time frame: 12 Months
First Harmonic
Time frame: 12 Months
Results and safety
The study was stopped early (reason given: The study was determined to not be feasible at this time.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- Individual participant dataSharing planned: No. There would not be any plans in place to share IPD. All data will be de-identified and not linked to any individual participant.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperventilation and CO2 challenge in people with Cerebral Cavernous Malformation, run by University of New Mexico at 1 site 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 9 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 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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: The study was determined to not be feasible at this time.). 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?
Hemodynamic Response (time frame: 12 Months). The study lists 2 primary outcomes in all. 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 11 Jun 2025.