UMIN-CTR Clinical Trial

Public title

The elucidation of glial function in intractable epilepsy and standardization of clinical practice guidelines

Acronym

The elucidation of the role of glial function in intractable epilepsy

Scientific Title

The elucidation of glial function in intractable epilepsy and standardization of clinical practice guidelines

Scientific Title:Acronym

The elucidation of the role of glial function in intractable epilepsy

Region

Japan

Condition

Epilepsy

Classification by specialty

Neurology

Neurosurgery

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

So far, We considered that epilepsy is caused by excessive paroxysmal excitability of the neurons. However, we can't explain the whole mechanism of the epilepsy only neurons. Therefore, in this study, we try to elucidate the role of glial function which is thoght to be related to the control of neuron excitability in epilepsy.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The result of electorocorticogram by subdural electrodes implanted for clinical purpose in intractable partial epileptic patients

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

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

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

The intractable epilepsy patients implanted chronic subdural electrodes for clinical purpose before surgery

Key exclusion criteria

nothing particular

Target sample size

100

Name of lead principal investigator

1st name
Middle name
Last name	Akio Ikeda

Organization

Kyoto University, Graduate School of Medicine

Division name

Department of Epilepsy, Movement Disorders and Physiology

Zip code

Address

kawaramachi 54, Shogoin, Sakyo-ku, Kyoto, 606-8507, JAPAN

TEL

075-751-3662

Email

akio@kuhp.kyoto-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Moritoo Inouchi

Organization

Kyoto University, Graduate School of Medicine

Division name

Department of Respiratory Care and Sleep Control Medicine

Zip code

Address

kawaramachi 54, Shogoin, Sakyo-ku, Kyoto, 606-8507, JAPAN

TEL

075-751-3772

Homepage URL

http://www.kuhp.kyoto-u.ac.jp/~neurology/patient/news/index.html

Email

inouchi@kuhp.kyoto-u.ac.jp

Institute

Department of Epilepsy, Movement Disorders and Physiology, Kyoto University, Graduate School of Medicine

Institute

Department

Personal name

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Tokyo medical and dental university, department of neurosurgery,
National center of neurology and psychiatry,
National epilepsy center, Shizuoka institute of epilepsy and neurological disorders,
Nishi-Niigata chuo national hospital, department of neurosurgery

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

京都大学医学部附属病院

Date of disclosure of the study information

2016

Year

07

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

No longer recruiting

Date of protocol fixation

2016

Year

07

Month

19

Day

Date of IRB

Anticipated trial start date

2016

Year

07

Month

19

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This research is mainly retrospective observational research of intractable epileptic patients who underwent chronic subdural electrodes implantation for clinical purpose.

We choose the ictal DC shifts which are expected to be generated by glial cells as main observational items, and analyze their onset time, distributions and waveform in order to extract the features of DC shifts by comparing 1)epileptic focus determined by other clinical findings, 2)HFOs generated by neurons, and 3)the pathological findings of resected areas, and then try to elucidate the relevance of glial cells to epileptic seizures.

Registered date

2016

Year

06

Month

27

Day

Last modified on

2018

Year

06

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025920