NIRS to Evaluate Haemodynamic Reserve in Paediatric Moyamoya

Not Applicable

Suspended

• Conditions: Moyamoya
• Interventions: Device: near infrared spectroscopy

• Registration Number: NCT05160454
• Lead Sponsor: Great Ormond Street Hospital for Children NHS Foundation Trust

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.

Detailed Description

Moyamoya disease is a cerebrovascular condition in which there is chronic brain hypoperfusion. As surgery can possibly augment brain blood flow, a method for evalutaing cerebrovascualr reserve would be helpful in selecting patients for intervention.

Near infrared spectroscopy (NIRS) is a validated non-invasive method of evaluating cerebral blood flow. We aim to investigate the feasibility and tolerability of using NIRS haemodynamic reserve in children with moyamoya and controls by evaluating cerebral blood flow in the baseline state and after breath-holding.

Feasibility will be assessed by how many successful studies are carried out. Tolerability will be assessed by asking children some simple questions about their experience.

Study Timeline

• Study Start: 2018-02-14
• Study First Submitted: 2019-11-08
• Status Verified: 2021-11
• Study First Submitted QC: 2021-12-02
• Last Update Submitted: 2021-12-02
• Study First Posted: 2021-12-16
• Last Update Posted: 2021-12-16
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Patients with moyamoya and unaffected healthy controls -

Exclusion Criteria

age <6

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
control	near infrared spectroscopy	unaffected control
patient	near infrared spectroscopy	child with moyamoya

Primary Outcome Measures

Name	Time	Method
Number of NIRS studies that can be completed in moyamoya patients	2years	how many studies can be completed

Secondary Outcome Measures

Name	Time	Method
Patient questionnaire to evaluate children's experience of NIRS in moyamoya	2years	ask children re their experience

Trial Locations

Locations (1)

Great Ormond Street Hospital for Children NHS Foundation Trust; 🇬🇧 London, United Kingdom