UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of epileptic seizure prediction system for on-demand seizure intervention in intractable epilepsy patients
Title of the study (Brief title)	Development of epileptic seizure prediction system for on-demand seizure intervention in intractable epilepsy patients
Region	Japan

Condition
Condition	Epilepsy
Classification by specialty	Neurology Pediatrics Psychiatry Neurosurgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Developing a seizure prediction system
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Psychological prediction performance index of seizure prediction system: sensitivity 95% and false positive frequency 0.1 times/h Evaluation time: from the eighth week on both index
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Implementation test of the seizure prediction device: 0 to 8th week
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who are hospitalized for epilepsy treatment and who performs long-term video EEG examination Patients who are hospitalized for epilepsy treatment but who do not performs long-term video EEG examination Outpatient patients for epilepsy diagnosis
Key exclusion criteria	Patients who are judged inappropriate by a doctor ex) patients who can not wear a device due to serious complications, uncooperative patients etc.)
Target sample size	1000

Research contact person
Name of lead principal investigator	Miho Miyajima
Organization	Tokyo Medical and Dental University Medical Hospital
Division name	Psychosomatic and Palliative Medicine
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL	03-5803-5673
Email	miholppm@tmd.ac.jp

Public contact
Name of contact person	Miho Miyajima
Organization	Tokyo Medical and Dental University Medical Hospital
Division name	Psychosomatic and Palliative Medicine
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL	03-5803-5673
Homepage URL
Email	miholppm@tmd.ac.jp

Sponsor
Institute	Japan Agency for Medical Research and Development
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 11 Month 16 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2017 Year 12 Month 31 Day
Anticipated trial start date	2017 Year 12 Month 31 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 11 Month 15 Day
Last modified on	2018 Year 05 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034248