EEG With Periodic AbnormalitiesNCT03173014
EEG Monitoring in Children With Moyamoya Disease
An observational study of EEG With Periodic Abnormalities, run by Seoul National University Hospital at 2 sites in South Korea.
Trial summary
EEG in moyamoya disease in children preoperatively Read more about this study
- Who is it for?
- Ages 5 to 10 years
- Conditions the study is for
- EEG With Periodic Abnormalities
- What is being tested?
- EEG
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 30 Jun 2017to 5 Jun 2018
- Phase
- Observational
- 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 5 to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: children with moyamoya disease from 5-10 years old
Who may be able to join
- moyamoya disease
Who cannot join
- refusal
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites, 2 recruiting
- Recruiting
Hee-Soo Kim
Seoul, Soul-t'ukpyolsi, 03080
Hee-Soo Kim, 1052878006, dami0605@snu.ac.kr
- Recruiting
Seoul National University Hospital
Seoul
About this study
Official title: EEG Finding in Moyamoya Disease in Children
EEG in moyamoya disease in children preoperatively
Read the detailed description
EEG monitoring in children with moyamoy disease preoperatively for 10 minutes
- Conditions
- EEG With Periodic Abnormalities
- Being tested
- EEG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEGDevice
EEG monitoring
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG
EEG finding
Measured: preoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2017
- Study start30 Jun 2017
- Primary completion30 May 2018 (estimated)
- Study completion5 Jun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EEG With Periodic AbnormalitiesStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hee-Soo Kim, Seoul National University Hospital
- Investigators
- Hee-Soo Kim, Principal investigator, Seoul National University Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03173014
- Sponsor's protocol ID
- 1705-013-851
- Status last verified
- Jul 2017
- First submitted
- 30 May 2017
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EEG Finding in Moyamoya Disease in Children
- ClinicalTrials.gov ID
- NCT03173014
- Acronym / sponsor ID
- 1705-013-851
- Conditions
- EEG With Periodic Abnormalities
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 30 Jun 2017 (actual)
- Primary completion
- 30 May 2018 (estimated)
- Study completion
- 5 Jun 2018 (estimated)
- First posted
- 1 Jun 2017 (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.
EEG in moyamoya disease in children preoperatively
Detailed description
EEG monitoring in children with moyamoy disease preoperatively for 10 minutes
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- children with moyamoya disease from 5-10 years old
Key inclusion criteria (1 listed)
- moyamoya disease
Key exclusion criteria (1 listed)
- refusal
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 |
|---|---|---|
| EEGEEG monitoring | Device | – |
Primary outcome
EEG
Time frame: preoperative
EEG finding
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
- Individual participant dataSharing planned: Undecided
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RecruitingObservational study
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Perioperative/Postoperative Complications, Postoperative Cognitive Dysfunction
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.
Hee-Soo Kim principal investigator
Seoul National University Children's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of EEG With Periodic Abnormalities, run by Seoul National University Hospital at 2 sites in South Korea.
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 1 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: status not confirmed, as of the sponsor's last update on 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. 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?
Contact Hee-Soo Kim (1052878006, dami0605@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EEG (time frame: preoperative). 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 21 Jul 2017.