NCT02969213

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2016

Completed
13 days until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 21, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

November 21, 2016

Status Verified

November 1, 2016

Enrollment Period

2.1 years

First QC Date

October 19, 2016

Last Update Submit

November 17, 2016

Conditions

Epilepsy

Keywords

Electronic management of epilepsybiological etiologyChinese children

Outcome Measures

Primary Outcomes (1)

  • 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

    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

    up to 26 months

Other Outcomes (5)

  • gene mutation

    30 days after receipt of DNA sample

  • immune factors

    7days after receipt of blood sample or/and cerebrospinal fluid

  • metabolic factors

    7days after receipt of blood sample or/and urine

  • +2 more other outcomes

Study Arms (6)

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

Eligibility Criteria

AgeUp to 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

0-14 years old epilepsy patients in China

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ling Li

Shanghai, 200092, China

Location

Related Publications (14)

  • 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.

    PMID: 26659723BACKGROUND

  • Singh A, Trevick S. The Epidemiology of Global Epilepsy. Neurol Clin. 2016 Nov;34(4):837-847. doi: 10.1016/j.ncl.2016.06.015.

    PMID: 27719996RESULT

  • Lua 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.

    PMID: 23329469RESULT

  • Coles 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.

    PMID: 23962794RESULT

  • Tzallas 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.

    PMID: 25393786RESULT

  • Larner AJ. Teleneurology: an overview of current status. Pract Neurol. 2011 Oct;11(5):283-8. doi: 10.1136/practneurol-2011-000090.

    PMID: 21921003RESULT

  • Hani 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.

    PMID: 26022171RESULT

  • Bearden 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.

    PMID: 25042079RESULT

  • Wright S, Vincent A. Progress in autoimmune epileptic encephalitis. Curr Opin Neurol. 2016 Apr;29(2):151-7. doi: 10.1097/WCO.0000000000000304.

    PMID: 26886357RESULT

  • Patel 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.

    PMID: 26821542RESULT

  • Kim 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.

    PMID: 27186225RESULT

  • Bonello 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.

    PMID: 26060903RESULT

  • Zhang 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.

    PMID: 40209515DERIVED

  • Yin 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.

    PMID: 34939173DERIVED

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
chief physician,proffessor

Study Record Dates

First Submitted

October 19, 2016

First Posted

November 21, 2016

Study Start

November 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2019

Last Updated

November 21, 2016

Record last verified: 2016-11

Locations

CN(1)