UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006121 |
|---|---|
| Receipt number | R000007241 |
| Scientific Title | Development of nonresective treatment for truly intractable epilepsy |
| Date of disclosure of the study information | 2011/08/06 |
| Last modified on | 2023/09/04 11:14:05 |
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Basic information
Public title
Development of nonresective treatment for truly intractable epilepsy
Acronym
Development of nonresective treatment for epilepsy
Scientific Title
Development of nonresective treatment for truly intractable epilepsy
Scientific Title:Acronym
Development of nonresective treatment for epilepsy
Region
| Japan |
Condition
Condition
epilepsy
Classification by specialty
| Neurology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop nonresective treatment like electrical stimulation and cooling for truly intractable epilepsy by measuring normal and pathological brain activity using cutting-edge of engineering and technology and by establishing a novel concept of epileptic focus and its detection
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Frequency of epileptic seizure
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
(1)Analysis of brain activity in patients with nonlesional partial epilepsy, (2)Development of intracranial electrodes for simultaneous recording of ECoG and single unit, (3)Development of a functional-mapping module and a seizure-detection/prediction module, (4)Development of treatment system using electrical stimulation and local cooling responding to seizures
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
| 15 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with medically intractable epilepsy for whom standard resective surgery is not curable
Key exclusion criteria
None
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Seijiro |
| Middle name | |
| Last name | Shimada |
Organization
University of Tokyo
Division name
Hospital
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo, Tokyo
TEL
0358008853
seshimada-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Seijiro |
| Middle name | |
| Last name | Shimada |
Organization
University of Tokyo, Graduate School of Medicine
Division name
Department of Neurosurgery
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo, Tokyo
TEL
0358008853
Homepage URL
seshimada-tky@umin.ac.jp
Sponsor or person
Institute
University of Tokyo, Graduate School of Medicine, Department of Neurosurgery
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of the Faculty of Medicine of the University of Tokyo
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
Tel
03-5841-0818
ethics@m.u-tokyo.ac.jp
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
| 2011 | Year | 08 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2011 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2011 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2011 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 08 | Month | 05 | Day |
Last modified on
| 2023 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007241
