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

University of New Mexico1 site in 1 country5 target enrollmentJune 15, 2023

ConditionsCerebral Cavernous Malformation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cerebral Cavernous Malformation
Sponsor: University of New Mexico
Enrollment: 5
Locations: 1
Primary Endpoint: Hemodynamic Response
Status: Terminated
Last Updated: 10 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

June 15, 2023

End Date

July 17, 2024

Last Updated

10 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University of New Mexico

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

•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.)
•People unable to consent.
•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.)

Outcomes

Primary Outcomes

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.