NCT05160454

Brief Summary

Near infrared spectroscpy is a validated method of evaluating cerebral blood flow. The aim in this pilot study to explore its use in children with moyamoya disease.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 14, 2018

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 8, 2019

Completed
2.1 years until next milestone

First Posted

Study publicly available on registry

December 16, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

December 16, 2021

Status Verified

November 1, 2021

Enrollment Period

4.4 years

First QC Date

November 8, 2019

Last Update Submit

December 2, 2021

Conditions

Moyamoya

Outcome Measures

Primary Outcomes (1)

  • Number of NIRS studies that can be completed in moyamoya patients

    how many studies can be completed

    2years

Secondary Outcomes (1)

  • Patient questionnaire to evaluate children's experience of NIRS in moyamoya

    2years

Study Arms (2)

patient

ACTIVE COMPARATOR

child with moyamoya

Device: near infrared spectroscopy

control

ACTIVE COMPARATOR

unaffected control

Device: near infrared spectroscopy

Interventions

near infrared spectroscopyDEVICE

evaluate cerebral blood flow with and without breatholding

controlpatient

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Great Ormond Street Hospital for Children NHS Foundation Trust

London, WC1N 3JH, United Kingdom

Location

MeSH Terms

Conditions

Moyamoya Disease

Interventions

Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

Carotid Artery DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCerebral Arterial DiseasesIntracranial Arterial DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisSpectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: patients and controls
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2019

First Posted

December 16, 2021

Study Start

February 14, 2018

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

December 16, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)