What this study is
The goal of this work is to use advanced magnetic resonance imaging (MRI) methods to assess brain blood flow and vascular function in adults with moyamoya disease (MMD). MMD is a condition characterized by narrowing or obstruction of major arteries in the brain and people with MMD have a high risk of stroke. Study participants will be enrolled from Vanderbilt University Medical Center and Johns Hopkins Hospital and will undergo up to two MRI scans where measurements of cerebrovascular reserve are performed using inhaled room air mixed with 5% carbon dioxide. Scans will be performed before and after surgeries to treat MMD, all surgeries are clinically indicated and are not research procedures. To further understand how surgeries impact brain health, we will also perform neurological exams and cognitive testing at approximately the same time as the imaging scans. The overall goal is to incorporate advanced imaging and cognitive assessments to understand how surgeries improve brain health in these patients, and furthermore, to use this information to develop improved screening tools for stroke risk and decisions about surgery.
What's being tested
- BOLD MRI
Intervention · OTHER
The study will utilize the MRI diagnostic reactivity test to evaluate cerebrovascular reactivity in patients with moyamoya and healthy controls. All participants (patients and controls) receive the same diagnostic scan, and there is no cross-over, factorial, or sequential nature to the study.
Study details
- Official title
- Personalized Hemodynamic and Metabolic Signatures of Revascularization Response in Moyamoya Disease
- Sponsor
- Vanderbilt University Medical Center
- Conditions
- Moyamoya Disease
- Enrolling
- 100 people
- Starts
- 2023-09-11
- Est. completion
- 2030-09-11
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 69 YearsSex ALLHealthy volunteers AcceptedYou may qualify if
- Moyamoya
- Clinical diagnosis of moyamoya disease as defined by gold-standard catheter angiography and consensus adjudication of imaging and neurological findings
- Age = 18-60 years
- Participants for the surgical revascularization aims must be scheduled for clinically indicated indirect surgical revascularization of at least one hemisphere
- Speak and read English Healthy controls
- No major medical conditions
- Age = 18-60 years
- Speak and read English
- Able to complete 2 study MRIs and all other study procedures
You can't join if
- Both moyamoya and healthy controls
- History of other major neurological conditions (including but not limited to Parkinson's disease, Alzheimer's disease, and Multiple Sclerosis) as confirmed by neuroimaging and neurological evaluation (central adjudication committee).
- History of traumatic brain injury
- Independent medical condition expected to lead to death within two years.
- Condition associated with syndromic moyamoya (including but not limited to sickle cell disease, atherosclerosis, neurofibromatosis, Down syndrome).
- Severe respiratory illness including but not limited to asthma or chronic obstructive pulmonary disease.
- Contraindication to 3 Tesla MRI 8. Pregnancy
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openJohns Hopkins University
Baltimore, Maryland, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Study team
Sponsor
Vanderbilt University Medical Center
Study ID 231114
Principal investigator
Manus J Donahue, MBA, PhD
Vanderbilt University Medical Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.