EpilepsyNCT02969213
Big Data Construction and Biological Etiological Epidemiology Study of Children Epilepsy in China
An observational study of Epilepsy, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
The purpose of this study is to develop the electronic management platform for children with epilepsy, establish large data of Chinese children with epilepsy and explore its biological etiology. Read more about this study
- Who is it for?
- Ages Up to 14 years
- Conditions the study is for
- Epilepsy
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- Nov 2016to Dec 2019
- 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 Up to 14 years
- All sexes
- No healthy volunteers
- Child
Study population: 0-14 years old epilepsy patients in China
Who may be able to join
- Children with epilepsy diagnosis, seizure types and causes of disease classification in accordance with the International Association for the diagnosis and treatment of epilepsy in 2015 guidelines
- Epilepsy children Included 0-14 years old from outpatients and inpatients by the Children's epilepsy specialist using iGrowSys management platform and clinical research, and medical records data entry complete in all China
Who cannot join
- The patients that recorded data is not complete, telephone and communication address unknown
- The patients that families do not have Internet or children and families will not access the Internet, can not be online operation
Trial locations and contacts
1 site in 1 country.
China1 site
Ling Li
Shanghai, 200092
Ling Li, PhD, 13651715616, linglidoctor@163.com
Mei Yu Yan, PhD, 15800793973, yanyumei_020601@163.com
About this study
The purpose of this study is to develop the electronic management platform for children with epilepsy, establish large data of Chinese children with epilepsy and explore its biological etiology.
Read the detailed description
The establishment of the electronic management platform for children with epilepsy and large data of epilepsy in Chinese children as well as the epidemiological study its biological etiology.
- Conditions
- Epilepsy
- Keywords
- Electronic management of epilepsy, biological etiology, Chinese children
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Genetic | patients with Gene detection (+) | |
| Metabolism | patients with Metabolic disturbance | |
| Immune | patients with Immunological marker and Immunotherapy (+) | |
| infection | patients with the Infection of central nervous system | |
| structure | patients with abnormal image of brain | |
| unknown | patients not found any reason |
What is being measured
The primary outcome is the main question the study is designed to answer.
The data of over 10 thousand childhood epilepsy patients in China
To develop a public platform for electronic analysis and management of children epilepsy to doctors and patients in China
Measured: 26 month after developing a public platform for electronic analysis and management
Secondary outcomes (1)
Incidence of several different causes of children epilepsy in China
A surveillance mechanism will be developed to identify and recruit children with epilepsy from the public platform for electronic analysis management of children epilepsy for doctors and patients
Measured: up to 26 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe 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
- Time perspective
- Retrospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ling Li, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02969213
- Sponsor's protocol ID
- XH-16-029
- Status last verified
- Nov 2016
- First submitted
- 19 Oct 2016
- Last updated
- 21 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Sauro KM, Wiebe S, Dunkley C, Janszky J, Kumlien E, Moshe S, Nakasato N, Pedley TA, Perucca E, Senties H, Thomas SV, Wang Y, Wilmshurst J, Jette N. The current state of epilepsy guidelines: A systematic review. Epilepsia. 2016 Jan;57(1):13-23. doi: 10.1111/epi.13273. Epub 2015 Dec 10.
PubMed 26659723Singh A, Trevick S. The Epidemiology of Global Epilepsy. Neurol Clin. 2016 Nov;34(4):837-847. doi: 10.1016/j.ncl.2016.06.015.
PubMed 27719996Lua PL, Neni WS. Health-related quality of life improvement via telemedicine for epilepsy: printed versus SMS-based education intervention. Qual Life Res. 2013 Oct;22(8):2123-32. doi: 10.1007/s11136-013-0352-6. Epub 2013 Jan 18.
PubMed 23329469Coles LD, Patterson EE, Sheffield WD, Mavoori J, Higgins J, Michael B, Leyde K, Cloyd JC, Litt B, Vite C, Worrell GA. Feasibility study of a caregiver seizure alert system in canine epilepsy. Epilepsy Res. 2013 Oct;106(3):456-60. doi: 10.1016/j.eplepsyres.2013.06.007. Epub 2013 Aug 18.
PubMed 23962794Tzallas AT, Tsipouras MG, Rigas G, Tsalikakis DG, Karvounis EC, Chondrogiorgi M, Psomadellis F, Cancela J, Pastorino M, Waldmeyer MT, Konitsiotis S, Fotiadis DI. PERFORM: a system for monitoring, assessment and management of patients with Parkinson's disease. Sensors (Basel). 2014 Nov 11;14(11):21329-57. doi: 10.3390/s141121329.
PubMed 25393786Larner AJ. Teleneurology: an overview of current status. Pract Neurol. 2011 Oct;11(5):283-8. doi: 10.1136/practneurol-2011-000090.
PubMed 21921003Hani AJ, Mikati HM, Mikati MA. Genetics of pediatric epilepsy. Pediatr Clin North Am. 2015 Jun;62(3):703-22. doi: 10.1016/j.pcl.2015.03.013.
PubMed 26022171Bearden D, Strong A, Ehnot J, DiGiovine M, Dlugos D, Goldberg EM. Targeted treatment of migrating partial seizures of infancy with quinidine. Ann Neurol. 2014 Sep;76(3):457-61. doi: 10.1002/ana.24229. Epub 2014 Jul 26.
PubMed 25042079Wright S, Vincent A. Progress in autoimmune epileptic encephalitis. Curr Opin Neurol. 2016 Apr;29(2):151-7. doi: 10.1097/WCO.0000000000000304.
PubMed 26886357Patel J, Mercimek-Mahmutoglu S. Epileptic Encephalopathy in Childhood: A Stepwise Approach for Identification of Underlying Genetic Causes. Indian J Pediatr. 2016 Oct;83(10):1164-74. doi: 10.1007/s12098-015-1979-9. Epub 2016 Jan 29.
PubMed 26821542Kim EH, Ko TS. Cognitive impairment in childhood onset epilepsy: up-to-date information about its causes. Korean J Pediatr. 2016 Apr;59(4):155-64. doi: 10.3345/kjp.2016.59.4.155. Epub 2016 Apr 30.
PubMed 27186225Bonello M, Michael BD, Solomon T. Infective Causes of Epilepsy. Semin Neurol. 2015 Jun;35(3):235-44. doi: 10.1055/s-0035-1552619. Epub 2015 Jun 10.
PubMed 26060903Zhang Z, Wu J, Xu D, Zhao S, Lian D, Zhang D, Li L. Clinical characteristics and immunotherapy efficacy in autoimmune-associated benign epilepsy with centrotemporal spikes: A prospective cohort study. J Neuroimmunol. 2025 Jul 15;404:578603. doi: 10.1016/j.jneuroim.2025.578603. Epub 2025 Apr 4.
PubMed 40209515Yin Y, Wu J, Wu S, Chen S, Cheng W, Li L, Wang H. Usefulness of brain FDG PET/CT imaging in pediatric patients with suspected autoimmune encephalitis from a prospective study. Eur J Nucl Med Mol Imaging. 2022 May;49(6):1918-1929. doi: 10.1007/s00259-021-05649-w. Epub 2021 Dec 23.
PubMed 34939173
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Big Data Construction and Biological Etiological Epidemiology Study of Children Epilepsy in China
- ClinicalTrials.gov ID
- NCT02969213
- Acronym / sponsor ID
- XH-16-029
- Conditions
- Epilepsy
- Keywords
- Electronic management of epilepsy, biological etiology, Chinese children
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 21 Nov 2016 (estimated)
- 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.
The purpose of this study is to develop the electronic management platform for children with epilepsy, establish large data of Chinese children with epilepsy and explore its biological etiology.
Detailed description
The establishment of the electronic management platform for children with epilepsy and large data of epilepsy in Chinese children as well as the epidemiological study its biological etiology.
Study design
- Time perspective
- Retrospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Genetic | – | –patients with Gene detection (+) |
| Metabolism | – | –patients with Metabolic disturbance |
| Immune | – | –patients with Immunological marker and Immunotherapy (+) |
| infection | – | –patients with the Infection of central nervous system |
| structure | – | –patients with abnormal image of brain |
| unknown | – | –patients not found any reason |
Who may qualify
- Ages
- Up to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 0-14 years old epilepsy patients in China
Key inclusion criteria (2 listed)
- Children with epilepsy diagnosis, seizure types and causes of disease classification in accordance with the International Association for the diagnosis and treatment of epilepsy in 2015 guidelines
- Epilepsy children Included 0-14 years old from outpatients and inpatients by the Children's epilepsy specialist using iGrowSys management platform and clinical research, and medical records data entry complete in all China
Key exclusion criteria (2 listed)
- The patients that recorded data is not complete, telephone and communication address unknown
- The patients that families do not have Internet or children and families will not access the Internet, can not be online operation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The data of over 10 thousand childhood epilepsy patients in China
Time frame: 26 month after developing a public platform for electronic analysis and management
To develop a public platform for electronic analysis and management of children epilepsy to doctors and patients in China
1 secondary outcome
Incidence of several different causes of children epilepsy in China
Time frame: up to 26 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2016.
- Background: PubMed 26659723Sauro KM, Wiebe S, Dunkley C, Janszky J, Kumlien E, Moshe S, Nakasato N, Pedley TA, Perucca E, Senties H, Thomas SV, Wang Y, Wilmshurst J, Jette N. The current state of epilepsy guidelines: A systematic review. Epilepsia. 2016 Jan;57(1):13-23. doi: 10.1111/epi.13273. Epub 2015 Dec 10.
- Results publication: PubMed 27719996Singh A, Trevick S. The Epidemiology of Global Epilepsy. Neurol Clin. 2016 Nov;34(4):837-847. doi: 10.1016/j.ncl.2016.06.015.
- Results publication: PubMed 23329469Lua PL, Neni WS. Health-related quality of life improvement via telemedicine for epilepsy: printed versus SMS-based education intervention. Qual Life Res. 2013 Oct;22(8):2123-32. doi: 10.1007/s11136-013-0352-6. Epub 2013 Jan 18.
- Results publication: PubMed 23962794Coles LD, Patterson EE, Sheffield WD, Mavoori J, Higgins J, Michael B, Leyde K, Cloyd JC, Litt B, Vite C, Worrell GA. Feasibility study of a caregiver seizure alert system in canine epilepsy. Epilepsy Res. 2013 Oct;106(3):456-60. doi: 10.1016/j.eplepsyres.2013.06.007. Epub 2013 Aug 18.
- Results publication: PubMed 25393786Tzallas AT, Tsipouras MG, Rigas G, Tsalikakis DG, Karvounis EC, Chondrogiorgi M, Psomadellis F, Cancela J, Pastorino M, Waldmeyer MT, Konitsiotis S, Fotiadis DI. PERFORM: a system for monitoring, assessment and management of patients with Parkinson's disease. Sensors (Basel). 2014 Nov 11;14(11):21329-57. doi: 10.3390/s141121329.
- Results publication: PubMed 21921003Larner AJ. Teleneurology: an overview of current status. Pract Neurol. 2011 Oct;11(5):283-8. doi: 10.1136/practneurol-2011-000090.
- Results publication: PubMed 26022171Hani AJ, Mikati HM, Mikati MA. Genetics of pediatric epilepsy. Pediatr Clin North Am. 2015 Jun;62(3):703-22. doi: 10.1016/j.pcl.2015.03.013.
- Results publication: PubMed 25042079Bearden D, Strong A, Ehnot J, DiGiovine M, Dlugos D, Goldberg EM. Targeted treatment of migrating partial seizures of infancy with quinidine. Ann Neurol. 2014 Sep;76(3):457-61. doi: 10.1002/ana.24229. Epub 2014 Jul 26.
- Results publication: PubMed 26886357Wright S, Vincent A. Progress in autoimmune epileptic encephalitis. Curr Opin Neurol. 2016 Apr;29(2):151-7. doi: 10.1097/WCO.0000000000000304.
- Results publication: PubMed 26821542Patel J, Mercimek-Mahmutoglu S. Epileptic Encephalopathy in Childhood: A Stepwise Approach for Identification of Underlying Genetic Causes. Indian J Pediatr. 2016 Oct;83(10):1164-74. doi: 10.1007/s12098-015-1979-9. Epub 2016 Jan 29.
- Results publication: PubMed 27186225Kim EH, Ko TS. Cognitive impairment in childhood onset epilepsy: up-to-date information about its causes. Korean J Pediatr. 2016 Apr;59(4):155-64. doi: 10.3345/kjp.2016.59.4.155. Epub 2016 Apr 30.
- Results publication: PubMed 26060903Bonello M, Michael BD, Solomon T. Infective Causes of Epilepsy. Semin Neurol. 2015 Jun;35(3):235-44. doi: 10.1055/s-0035-1552619. Epub 2015 Jun 10.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
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 2 inclusion and 2 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 Nov 2016. 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 China. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The data of over 10 thousand childhood epilepsy patients in China (time frame: 26 month after developing a public platform for electronic analysis and management). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02969213, which also lists 14 linked publications.
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 Nov 2016.