Back to resultsNIRS to Evaluate Haemodynamic Reserve in Paediatric Moyamoya (NIRS moyamoya)
Primary Purpose
Moyamoya
Status
Suspended
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
near infrared spectroscopy
Sponsored by
About this trial
This is an interventional other trial for Moyamoya
Eligibility Criteria
Inclusion Criteria: Patients with moyamoya and unaffected healthy controls -
Exclusion Criteria: age <6
-
Sites / Locations
- Great Ormond Street Hospital for Children NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
patient
control
Arm Description
child with moyamoya
unaffected control
Outcomes
Primary Outcome Measures
Number of NIRS studies that can be completed in moyamoya patients
how many studies can be completed
Secondary Outcome Measures
Patient questionnaire to evaluate children's experience of NIRS in moyamoya
ask children re their experience
Full Information
NCT ID
NCT05160454
First Posted
November 8, 2019
Last Updated
December 2, 2021
Sponsor
Great Ormond Street Hospital for Children NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT05160454
Brief Title
NIRS to Evaluate Haemodynamic Reserve in Paediatric Moyamoya
Acronym
NIRS moyamoya
Official Title
NIRS to Evaluate Haemodynamic Reserve in Paediatric Moyamoya
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Suspended
Why Stopped
COVID19
Study Start Date
February 14, 2018 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Great Ormond Street Hospital for Children NHS Foundation Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moyamoya
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
patients and controls
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
patient
Arm Type
Active Comparator
Arm Description
child with moyamoya
Arm Title
control
Arm Type
Active Comparator
Arm Description
unaffected control
Intervention Type
Device
Intervention Name(s)
near infrared spectroscopy
Intervention Description
evaluate cerebral blood flow with and without breatholding
Primary Outcome Measure Information:
Title
Number of NIRS studies that can be completed in moyamoya patients
Description
how many studies can be completed
Time Frame
2years
Secondary Outcome Measure Information:
Title
Patient questionnaire to evaluate children's experience of NIRS in moyamoya
Description
ask children re their experience
Time Frame
2years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients with moyamoya and unaffected healthy controls -
Exclusion Criteria: age <6
-
Facility Information:
Facility Name
Great Ormond Street Hospital for Children NHS Foundation Trust
City
London
ZIP/Postal Code
WC1N 3JH
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
NIRS to Evaluate Haemodynamic Reserve in Paediatric Moyamoya
We'll reach out to this number within 24 hrs