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NIRS to Evaluate Haemodynamic Reserve in Paediatric Moyamoya

NCT ID: NCT05160454

Last Updated: 2021-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-14

Study Completion Date

2022-06-30

Brief Summary

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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

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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.

Conditions

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Moyamoya

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

patients and controls
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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patient

child with moyamoya

Group Type ACTIVE_COMPARATOR

near infrared spectroscopy

Intervention Type DEVICE

evaluate cerebral blood flow with and without breatholding

control

unaffected control

Group Type ACTIVE_COMPARATOR

near infrared spectroscopy

Intervention Type DEVICE

evaluate cerebral blood flow with and without breatholding

Interventions

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near infrared spectroscopy

evaluate cerebral blood flow with and without breatholding

Intervention Type DEVICE

Eligibility Criteria

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Exclusion Criteria

\-
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Great Ormond Street Hospital for Children NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Great Ormond Street Hospital for Children NHS Foundation Trust

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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16NC24

Identifier Type: -

Identifier Source: org_study_id