Moyamoya DiseaseBLOSSOMNCT06634004
Biomarker-Led Optimization of Successful Surgical Outcomes in Moyamoya
An observational study of Moyamoya Disease, run by Vanderbilt University Medical Center at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Moyamoya Disease
- What is being tested?
- BOLD MRI
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Sep 2023to 11 Sep 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults with moyamoya disease.
Who may be able to join
- 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
Show all 10Show fewer
- No major medical conditions
- Age = 18-60 years
- Speak and read English
- Able to complete 2 study MRIs and all other study procedures
Who cannot join
- -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.
- 7. Contraindication to 3 Tesla MRI 8. Pregnancy
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Johns Hopkins University
Baltimore, Maryland, 21218
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
About this study
Official title: Personalized Hemodynamic and Metabolic Signatures of Revascularization Response in Moyamoya Disease
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.
Read the detailed description
MMD is a condition with narrowing and blockage of major arteries in the brain and people with MMD have a high risk of stroke. Neurosurgical revascularization surgery is usually recommended to provide more blood flow to the brain and hopefully prevent further strokes. The primary goal of this study to improve the understanding of response to neurosurgical treatment and disease improvement or progression by using innovative magnetic resonance imaging (MRI) methods to assess brain blood flow and oxygen use in adults with idiopathic MMD before and after they have surgery.
The study will recruit 100 adults with idiopathic MMD, aged 18-60 years, from neurosurgery clinics at Vanderbilt University Medical Center and Johns Hopkins Hospital, as well as 20 healthy controls. Participants will undergo comprehensive evaluations including MRI, cognitive exams, and optional blood and urine collection.
More specifically, the proposal involves the development and application of MRI methods for visualizing hemodynamic and metabolic relationships in adults suffering from idiopathic moyamoya disease. As part of the research study, participants will undergo 1-2 MRI scans at a field strength of 3 Tesla. Each scan session will last approximately one hour, which will include the time when the volunteers rehearse the experiment outside of the scanner, time for the volunteers to be comfortably placed in the scanner, scanning (including one scan where blood flow and oxygenation will be measured before and during a mild hypercapnic stimulus), and finally time for the participants to slowly exit the scan room. Moyamoya participants may also undergo surgical revascularization and catheter angiography using digital subtraction angiography (DSA). These procedures are clinically indicated and will be performed as part of clinical care, and therefore are not research procedures. Therefore, the risks relevant to this study pertain to the research procedures only, which are comprised of non-invasive MRI scans, neurological exams, as well as cognitive testing. Neurological assessments will utilize the NIH Stroke Scale (NIHSS) and the modified Rankin Score (mRS) to evaluate disability. Neurocognitive testing will be completed to assess multiple cognitive domains.
Participants are not randomized to an intervention or study group but studying cerebral blood flow changes is considered a basic experimental study involving humans (BESH) clinical trial by the National Institutes of Health that funds this study. The study uses commercial MRI approaches and data-driven software approaches to ensure the tools are generalizable across medical centers. This comprehensive approach aims to identify which patients require specific treatments and understand what contributes to positive responses. Planned surgery for MMD is an inclusion criteria for this study for MMD participants. Again, surgery will be performed as a part of clinical care and is not a research procedure. Therefore, the risks relevant to this study pertain to the research procedures only, which are comprised of non-invasive MRI scans, neurological exams, as well as cognitive testing, blood and urine samples.
- Conditions
- Moyamoya Disease
- Being tested
- BOLD MRI
- Keywords
- moyamoya, stroke
- Medical subject headings
- Moyamoya Disease, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BOLD MRIOther
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 group | Role | What they receive |
|---|---|---|
| Moyamoya | Adults diagnosed with Moyamoya who are being considered for revascularization surgery. Receives: Other: BOLD MRI | |
| Control | Healthy adults who will under go a BOLD MRI for research purposes. Receives: Other: BOLD MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Revascularization success
The outcome measure will be the number of patients with successful surgical revascularization.
Measured: 6 years
Secondary outcomes (1)
Infarct development
The number of patients with new cerebral infarctions.
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start11 Sep 2023
- Primary completion11 Sep 2029 (estimated)
- Study completion11 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moyamoya DiseaseStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manus Donahue, Vanderbilt University Medical Center
- Investigators
- Manus J Donahue, MBA, PhD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06634004
- Sponsor's protocol ID
- 231114
- Other IDs
- 1R01NS133101
- Acronym
- BLOSSOM
- Status last verified
- Jan 2026
- First submitted
- 30 Sep 2024
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: This study will not be sharing IPD with other researchers in order to protect participant privacy.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Hemodynamic and Metabolic Signatures of Revascularization Response in Moyamoya Disease
- ClinicalTrials.gov ID
- NCT06634004
- Acronym / sponsor ID
- BLOSSOM / 231114
- Conditions
- Moyamoya Disease
- Keywords
- moyamoya, stroke
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 11 Sep 2023 (actual)
- Primary completion
- 11 Sep 2029 (estimated)
- Study completion
- 11 Sep 2030 (estimated)
- First posted
- 9 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
MMD is a condition with narrowing and blockage of major arteries in the brain and people with MMD have a high risk of stroke. Neurosurgical revascularization surgery is usually recommended to provide more blood flow to the brain and hopefully prevent further strokes. The primary goal of this study to improve the understanding of response to neurosurgical treatment and disease improvement or progression by using innovative magnetic resonance imaging (MRI) methods to assess brain blood flow and oxygen use in adults with idiopathic MMD before and after they have surgery.
The study will recruit 100 adults with idiopathic MMD, aged 18-60 years, from neurosurgery clinics at Vanderbilt University Medical Center and Johns Hopkins Hospital, as well as 20 healthy controls. Participants will undergo comprehensive evaluations including MRI, cognitive exams, and optional blood and urine collection.
More specifically, the proposal involves the development and application of MRI methods for visualizing hemodynamic and metabolic relationships in adults suffering from idiopathic moyamoya disease. As part of the research study, participants will undergo 1-2 MRI scans at a field strength of 3 Tesla. Each scan session will last approximately one hour, which will include the time when the volunteers rehearse the experiment outside of the scanner, time for the volunteers to be comfortably placed in the scanner, scanning (including one scan where blood flow and oxygenation will be measured before and during a mild hypercapnic stimulus), and finally time for the participants to slowly exit the scan room. Moyamoya participants may also undergo surgical revascularization and catheter angiography using digital subtraction angiography (DSA). These procedures are clinically indicated and will be performed as part of clinical care, and therefore are not research procedures. Therefore, the risks relevant to this study pertain to the research procedures only, which are comprised of non-invasive MRI scans, neurological exams, as well as cognitive testing. Neurological assessments will utilize the NIH Stroke Scale (NIHSS) and the modified Rankin Score (mRS) to evaluate disability. Neurocognitive testing will be completed to assess multiple cognitive domains.
Participants are not randomized to an intervention or study group but studying cerebral blood flow changes is considered a basic experimental study involving humans (BESH) clinical trial by the National Institutes of Health that funds this study. The study uses commercial MRI approaches and data-driven software approaches to ensure the tools are generalizable across medical centers. This comprehensive approach aims to identify which patients require specific treatments and understand what contributes to positive responses. Planned surgery for MMD is an inclusion criteria for this study for MMD participants. Again, surgery will be performed as a part of clinical care and is not a research procedure. Therefore, the risks relevant to this study pertain to the research procedures only, which are comprised of non-invasive MRI scans, neurological exams, as well as cognitive testing, blood and urine samples.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moyamoya | – | Other: BOLD MRIAdults diagnosed with Moyamoya who are being considered for revascularization surgery. |
| Control | – | Other: BOLD MRIHealthy adults who will under go a BOLD MRI for research purposes. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with moyamoya disease.
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (7 listed)
- -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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BOLD MRIThe 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. | Other | Control, Moyamoya |
Primary outcome
Revascularization success
Time frame: 6 years
The outcome measure will be the number of patients with successful surgical revascularization.
1 secondary outcome
Infarct development
Time frame: 6 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Individual participant dataSharing planned: No. This study will not be sharing IPD with other researchers in order to protect participant privacy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Manus J Donahue, MBA, PhD principal investigator
Vanderbilt University Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Moyamoya Disease, run by Vanderbilt University Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Revascularization success (time frame: 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.