Big Data Construction and Biological Etiological Epidemiology Study of Children Epilepsy in China

Epilepsy Clinical Trial

Official title:

Big Data Construction and Biological Etiological Epidemiology Study of Children Epilepsy in China

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02969213
• Other study ID #: XH-16-029
• Status: Not yet recruiting
• Phase: N/A
• First received: October 19, 2016
• Last updated: November 17, 2016
• Start date: November 2016
• Est. completion date: December 2019

Study information

• Verified date: November 2016
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Shanghai Municipal Commission of Health and Family Planning
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10000
• Est. completion date: December 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 14 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Epilepsy

Locations

Country	Name	City	State
China	Ling Li	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

References & Publications (12)

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. — View Citation

Bonello M, Michael BD, Solomon T. Infective Causes of Epilepsy. Semin Neurol. 2015 Jun;35(3):235-44. doi: 10.1055/s-0035-1552619. Review. — View Citation

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 — View Citation

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. Review. — View Citation

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. Review. — View Citation

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

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. — View Citation

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. Review. — View Citation

Sauro KM, Wiebe S, Dunkley C, Janszky J, Kumlien E, Moshé S, Nakasato N, Pedley TA, Perucca E, Senties H, Thomas SV, Wang Y, Wilmshurst J, Jetté N. The current state of epilepsy guidelines: A systematic review. Epilepsia. 2016 Jan;57(1):13-23. doi: 10.1111/epi.13273. Review. — View Citation

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. Review. — View Citation

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 dise — View Citation

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

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	gene mutation	To detect the mutation and characterize the genetic architecture and risk variants of epilepsy using genomic methods	30 days after receipt of DNA sample	No
Other	immune factors	To test Inflammatory factors, Autoimmune antibodies , Immunoglobulin	7days after receipt of blood sample or/and cerebrospinal fluid	No
Other	metabolic factors	To test tandem mass spectrometry and enzyme	7days after receipt of blood sample or/and urine	No
Other	structural factors	To scan head MRI	5ays after patients see doctor	No
Other	Infection factors	To test various pathogen	7days after receipt of blood sample, urine and cerebrospinal fluid	No
Primary	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	No
Secondary	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	up to 26 months	No