MoyamoyaNIRS moyamoyaNCT05160454
NIRS to Evaluate Haemodynamic Reserve in Paediatric Moyamoya
A study testing near infrared spectroscopy in people with Moyamoya, run by Great Ormond Street Hospital for Children NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Moyamoya
- What is being tested?
- near infrared spectroscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Feb 2018to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Great Ormond Street Hospital for Children NHS Foundation Trust
London, WC1N 3JH
About this study
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.
Read the 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.
- Conditions
- Moyamoya
- Being tested
- near infrared spectroscopy
- Medical subject headings
- Moyamoya Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
near infrared spectroscopyDevice
evaluate cerebral blood flow with and without breatholding
| Study group | Role | What they receive |
|---|---|---|
| patient | Active comparator | child with moyamoya Receives: Device: near infrared spectroscopy |
| control | Active comparator | unaffected control Receives: Device: near infrared spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of NIRS studies that can be completed in moyamoya patients
how many studies can be completed
Measured: 2years
Secondary outcomes (1)
Patient questionnaire to evaluate children's experience of NIRS in moyamoya
ask children re their experience
Measured: 2years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start14 Feb 2018
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Why it stopped: COVID19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MoyamoyaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- patients and controls
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Great Ormond Street Hospital for Children NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05160454
- Sponsor's protocol ID
- 16NC24
- Acronym
- NIRS moyamoya
- Status last verified
- Nov 2021
- First submitted
- 8 Nov 2019
- Last updated
- 16 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NIRS to Evaluate Haemodynamic Reserve in Paediatric Moyamoya
- ClinicalTrials.gov ID
- NCT05160454
- Acronym / sponsor ID
- NIRS moyamoya / 16NC24
- Conditions
- Moyamoya
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: COVID19
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Great Ormond Street Hospital for Children NHS Foundation TrustUniversity, hospital or other
- Study start
- 14 Feb 2018 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 16 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- patients and controls
| Arm | Type | Receives |
|---|---|---|
| patient | Active comparator | Device: near infrared spectroscopychild with moyamoya |
| control | Active comparator | Device: near infrared spectroscopyunaffected control |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| near infrared spectroscopyevaluate cerebral blood flow with and without breatholding | Device | control, patient |
Primary outcome
Number of NIRS studies that can be completed in moyamoya patients
Time frame: 2years
how many studies can be completed
1 secondary outcome
Patient questionnaire to evaluate children's experience of NIRS in moyamoya
Time frame: 2years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing near infrared spectroscopy in people with Moyamoya, run by Great Ormond Street Hospital for Children NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 16 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of NIRS studies that can be completed in moyamoya patients (time frame: 2years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2021.