NIRS to Evaluate Haemodynamic Reserve in Paediatric Moyamoya

Moyamoya Clinical Trial

— NIRS moyamoya  

Official title:

NIRS to Evaluate Haemodynamic Reserve in Paediatric Moyamoya

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05160454
• Other study ID #: 16NC24
• Status: Suspended
• Phase: N/A
• Start date: February 14, 2018
• Est. completion date: June 30, 2022

Study information

• Verified date: November 2021
• Source: Great Ormond Street Hospital for Children NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 20
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

Inclusion Criteria: Patients with moyamoya and unaffected healthy controls -

Exclusion Criteria: age <6

-

Related Conditions & MeSH terms

• Moyamoya
• Moyamoya Disease

Intervention

Device:
• near infrared spectroscopy
evaluate cerebral blood flow with and without breatholding

Locations

Country	Name	City	State
United Kingdom	Great Ormond Street Hospital for Children NHS Foundation Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Great Ormond Street Hospital for Children NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of NIRS studies that can be completed in moyamoya patients	how many studies can be completed	2years
Secondary	Patient questionnaire to evaluate children's experience of NIRS in moyamoya	ask children re their experience	2years