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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name