Managing Transient Neurologic Episodes in Surgery for Moyamoya Disease

NCT06880341 | Recruiting

• 1 other identifier: 77828
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to study the incidence of post-operative Transient Neurologic Events (TNEs) within 30 days postoperatively, as assessed by clinical neurological scales, binned by week. Collect data on all interventions and assessments performed during the recovery post surgery up to 30 days, to understand what factors might cause Transient Neurologic Events (TNEs) and determine how these can be reduced in Moyamoya subjects post surgery.

Conditions

Moya Moya Disease

Outcome Measures

Primary Outcomes (1)

• Transient Neurologic Events (TNEs)

  Number of Incidence of post-operative Transient Neurologic Events (TNEs) within 30 days postoperatively, as assessed by clinical neurological scales (e.g., NIH Stroke Scale, Modified Rankin Scale), binned by week.

  30 days post-surgery

Study Arms (1)

MoyaMoya Subjects

Subjects will receive standard of care moyamoya surgical intervention and be followed for 30 days post for transient neurological episodes (TNEs).

Other: Standard of Care

Interventions

Standard of Care OTHER

Standard of care treatment of Transient Neurologic Events (TNEs) as needed

MoyaMoya Subjects

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Moyamoya subject undergoing a standard of care direct and indirect extracranial-intracranial (ECIC) bypass.

You may qualify if:

• Moyamoya Disease (MMD) patients undergoing direct extracranial-intracranial (ECIC) bypass. Patients above the age of 3 years old are eligible for the study

You may not qualify if:

• Renal dysfunction, electrolyte disturbances neuromuscular disorders including Myaesthenia Gravis, heart block

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University Hospital

Palo Alto, California, 94305, United States

RECRUITING

MeSH Terms

Conditions

Moyamoya Disease

Interventions

Standard of Care

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Jinendra Ekanayake

CONTACT

650-660-1266; jine7000@stanford.edu

Anthony Bet

CONTACT

abet0915@stanford.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Former Chair, Department of Neurosurgery, School of Medicine

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 17, 2025
• Study Start: May 21, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)