Managing Transient Neurologic Episodes in Surgery for Moy... | NCT06880341

Studies
Managing Transient Neurologic Episodes in Surgery for Moyamoya Disease

NCT06880341

Sponsor

Stanford University

Status

Recruiting

Last Update Posted

May 28, 2025Actual

Enrollment

88Estimated

Phase

Not provided

Conditions

Moya Moya Disease

Interventions

Standard of Care

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 21, 2025Actual

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Mar 31, 2027Estimated

First Submitted Date

Mar 11, 2025

First Submission Date that Met QC Criteria

Mar 11, 2025

First Posted Date

Mar 17, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 21, 2025

Last Update Posted Date

May 28, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Gary Steinberg, MD, PhD, Professor and Former Chair, Department of Neurosurgery, School of Medicine, Stanford UniversityPrincipal Investigator

Lead Sponsor

Stanford UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

88Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Standard of Care	Other	Standard of care treatment of Transient Neurologic Events (TNEs) as needed	MoyaMoya Subjects

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jinendra Ekanayake	Contact	650-660-1266		jine7000@stanford.edu
Anthony Bet	Contact			abet0915@stanford.edu

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stanford University Hospital	Recruiting	Palo Alto	California	94305	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009072	Moyamoya Disease

Ancestor Terms

ID	Term
D002340	Carotid Artery Diseases
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D059039	Standard of Care

Ancestor Terms

ID	Term
D019984	Quality Indicators, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration
D017530	Health Care Quality, Access, and Evaluation

Browse Leaves

Not provided

Browse Branches

Not provided