Biomarker-Led Optimization of Successful Surgical Outcomes in Moyamoya

NCT06634004 | Enrolling By Invitation DMC FDA Drug

• 2 other identifiers: 2311141R01NS133101
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Moyamoya Disease

Keywords

moyamoya; stroke

Outcome Measures

Primary Outcomes (1)

• Revascularization success

  The outcome measure will be the number of patients with successful surgical revascularization.

  6 years

Secondary Outcomes (1)

• Infarct development

  6 years

Study Arms (2)

Moyamoya

Adults diagnosed with Moyamoya who are being considered for revascularization surgery.

Other: BOLD MRI

Control

Healthy adults who will under go a BOLD MRI for research purposes.

Other: BOLD MRI

Interventions

BOLD MRI 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.

Control; Moyamoya

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with moyamoya disease.

You 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 may not qualify 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (2)

Johns Hopkins University

Baltimore, Maryland, 21218, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood (10 mL) and Urine (10 mL) samples.

MeSH Terms

Conditions

Moyamoya Disease; Stroke

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cerebral Arterial Diseases; Intracranial Arterial Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Manus J Donahue, MBA, PhD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology

Study Record Dates

• First Submitted: September 30, 2024
• First Posted: October 9, 2024
• Study Start: September 11, 2023
• Primary Completion (Estimated): September 11, 2029
• Study Completion (Estimated): September 11, 2030
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)