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

Primary Purpose

Cerebral Cavernous Malformation

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Hyperventilation and CO2 challenge

About this trial

This is an interventional other trial for Cerebral Cavernous Malformation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.)
Prisoners.
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.)

Sites / Locations

University of New Mexico Neurology Research CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hypercarbia/Hypocarbia/resting state during fMRI

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Resting state connectivity

To measure the strength of resting-state connectivity during hypercarbia/hypocarbia using high-speed multi-echo resting-state functional MRI.

Secondary Outcome Measures

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

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.

Full Information

NCT ID

NCT05298709

First Posted

March 9, 2022

Last Updated

October 4, 2023

Sponsor

University of New Mexico

Collaborators

University of California, San Francisco

1. Study Identification

Unique Protocol Identification Number

NCT05298709

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 15, 2023 (Actual)

Primary Completion Date

April 17, 2024 (Anticipated)

Study Completion Date

June 14, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of New Mexico

Collaborators

University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cerebral Cavernous Malformation

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Hypercarbia/Hypocarbia/resting state during fMRI

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Hyperventilation and CO2 challenge

Intervention Description

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

Primary Outcome Measure Information:

Title

Hemodynamic Response

Description

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

Time Frame

12 Months

Title

Resting state connectivity

Description

To measure the strength of resting-state connectivity during hypercarbia/hypocarbia using high-speed multi-echo resting-state functional MRI.

Time Frame

12 month

Secondary Outcome Measure Information:

Title

Cardiac Pulsatility

Description

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

Time Frame

12 Months

Title

First Harmonic

Description

Time Frame

12 Months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.) Prisoners. 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.)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Michel Tobey, MD

Phone

(505) 272-3152

MTorbey@salud.unm.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Jacquelyn Morales

Phone

5052720356

jsmorales@salud.unm.edu

Facility Information:

Facility Name

University of New Mexico Neurology Research Center

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87106

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Michel Torbey, M.D.

Phone

505-272-3152

MTorbey@salud.unm.edu

First Name & Middle Initial & Last Name & Degree

Jacquelyn Morales

Phone

505-272-0356

jsmorales@salud.unm.edu

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

There would not be any plans in place to share IPD. All data will be de-identified and not linked to any individual participant.

Learn more about this trial

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

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