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Functional Magnetic Resonance Imaging (fMRI) Vascular Reactivity in Cerebral Cavernous Malformations (CCM)

Functional Magnetic Resonance Imaging (fMRI) Vascular Reactivity in Cerebral Cavernous Malformations (CCM)

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05298709
Enrollment
5
Registered
2022-03-28
Start date
2023-06-15
Completion date
2024-07-17
Last updated
2025-06-11

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

Conditions

Cerebral Cavernous Malformation

Brief 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

Interventions

OTHERHyperventilation and CO2 challenge

Subjects will also be asked to complete hyperventilation and CO2 breathing tasks based on instruction from the study investigators as described in study arm.

Sponsors

University of California, San Francisco
CollaboratorOTHER
University of New Mexico
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. All familial CCM subjects presenting at UNMH who can consent to our study. 2. Adult Male/Female patients ages \>18 years old

Exclusion criteria

1. Individuals ages \<18 year 2. 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. 3. Subjects who have contraindications to MRI such as harboring incompatible ferromagnetic objects implanted in the body. 4. 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.) 5. Prisoners. 6. People unable to consent. 7. People unable to participate due to prior neurological deficits. 8. Subjects with underlying pre-existing pulmonary illness; such as asthma, COPD, pulmonary hypertension, will be excluded. 9. 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.)

Design outcomes

Primary

MeasureTime frameDescription
Hemodynamic Response12 MonthsPrimary 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 connectivity12 monthTo measure the strength of resting-state connectivity during hypercarbia/hypocarbia using high-speed multi-echo resting-state functional MRI.

Secondary

MeasureTime frameDescription
Cardiac Pulsatility12 MonthsMeasure 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
First Harmonic12 MonthsTo 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.

Countries

United States

Outcome results

None listed

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