Managing Transient Neurologic Episodes in Surgery for Moyamoya Disease (MagNETs)

MagNETs- Managing Transient Neurologic Episodes in Surgery for Moyamoya Disease

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.

Study Overview

• Status: Recruiting
• Conditions: Moya Moya Disease
• Intervention / Treatment: Other: Standard of Care

• Study Type: Observational
• Enrollment (Estimated): 88

Contacts and Locations

• Study Contact: Name: Anthony Bet; Email: abet0915@stanford.edu
• Study Contact Backup: Name: Jinendra Ekanayake; Phone Number: 650-660-1266; Email: jine7000@stanford.edu

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94305
      • Recruiting
      • Stanford University Hospital
      • Contact: Gabriella Morton, BS; Phone Number: 6503047766; Email: neurosurgeryresearch@stanford.edu
      • Contact: Sasha Alexander; Email: neurosurgeryresearch@stanford.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Standard of care treatment of Transient Neurologic Events (TNEs) as needed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: March 11, 2025
• First Submitted That Met QC Criteria: March 11, 2025
• First Posted (Actual): March 17, 2025

Study Record Updates

• Last Update Posted (Actual): May 28, 2025
• Last Update Submitted That Met QC Criteria: May 21, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arterial Occlusive Diseases; Intracranial Arterial Diseases; Carotid Artery Diseases; Cerebral Arterial Diseases; Moyamoya Disease
• Other Study ID Numbers: 77828

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No