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

Cerebral Cavernous Malformation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05298709
• Other study ID #: 21-136
• Status: Recruiting
• Phase: N/A
• Start date: June 15, 2023
• Est. completion date: June 28, 2025

Study information

• Verified date: June 2024
• Source: University of New Mexico
• Contact: Michel Tobey, MD
• Phone: (505) 272-3152
• Email: MTorbey[@]salud.unm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: June 28, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Cerebral Cavernous Malformation
• Congenital Abnormalities

Intervention

Other:
• Hyperventilation 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.

Locations

Country	Name	City	State
United States	University of New Mexico Neurology Research Center	Albuquerque	New Mexico

Sponsors (2)

Lead Sponsor	Collaborator
University of New Mexico	University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 Months
Primary	Resting state connectivity	To measure the strength of resting-state connectivity during hypercarbia/hypocarbia using high-speed multi-echo resting-state functional MRI.	12 month
Secondary	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	12 Months
Secondary	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.	12 Months