UMIN-CTR Clinical Trial

Public title

Optimization of methods to suppress afterdischarges in direct cortical electrical stimulation

Acronym

Optimization of methods to suppress afterdischarges in direct cortical electrical stimulation

Scientific Title

Optimization of methods to suppress afterdischarges in direct cortical electrical stimulation

Scientific Title:Acronym

Optimization of methods to suppress afterdischarges in direct cortical electrical stimulation

Region

Japan

Condition

Epilepsy

Classification by specialty

Neurology

Neurosurgery

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Additional brief pulse cortical stimulations are reported to suppress afterdischarges induced by direct cortical stimulation during functional mapping of patients with subdural electrode implantation for possible epilepsy or lesion surgeries before they evolve into clinical seizures. We aim to optimize parameters such as interval between the stimulation which caused afterdischarges and a brief pulse cortical stimulation, and duration of a brief pulse cortical stimulation.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Electroencephalographic data during and after direct cortical electrical stimulation is to be analyzed. Statistical methods such as Student's t-test or analysis of variance will be used to analyze parameters such as the rate of afterdischarge suppression, interval between the stimulation which induced afterdischarges and a brief pulse cortical stimulation, and the duration of brief pulse cortical stimulation. Spectrogram is to be used to analyze the relationship between frequency changes of electroencephalographic waveform and timing of a brief pulse cortical stimulation.

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

Brief pulse cortical stimulation will be added in order to suppress afterdischarges induced by direct cortical stimulation. Intensity and frequency of brief pulse cortical stimulation will be equivalent to the stimulation which induced the afterdischarges. Duration of brief pulse cortical stimulation will be shorter than the stimulation which induced the afterdischarges, and will be generally shorter than 1 second.

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

10

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Medically intractable epilepsy patients undergoing subdural and/or depth electrode implantation for possible epilepsy or lesion surgeries.

Key exclusion criteria

When an informed consent is not obtained.

Target sample size

50

Name of lead principal investigator

1st name
Middle name
Last name	Akio Ikeda

Organization

Kyoto University School of Medicine

Division name

Department of Neurology

Zip code

Address

54, Shogoin, Sakyo-ku, Kyoto, 606-8508, JAPAN

TEL

Email

Name of contact person

1st name
Middle name
Last name

Organization

Kyoto University School of Medicine

Division name

Department of Neurology

Zip code

Address

54, Shogoin, Sakyo-ku, Kyoto, 606-8508, JAPAN

TEL

Homepage URL

Email

Institute

Kyoto University School of Medicine

Institute

Department

Personal name

Organization

Japan Society of the Promotion of Science

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Nihon Kohden Corporation

Name of secondary funder(s)

National Center of Neurology and Psychiatry

Takeda Science Foundation

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

Date of disclosure of the study information

2011

Year

11

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

Open public recruiting

Date of protocol fixation

2011

Year

11

Month

01

Day

Date of IRB

Anticipated trial start date

2011

Year

11

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

1)In this study, we also plan to optimize amplifier circuits of an electroencephalographic recorder in order to terminate electrode saturation due to a cortical stimulation, and to detect afterdischarges earlier so that neccessary brief pulse cortical stimulations can be given promptly, which will contribute to safer practice of functional cortical mapping.
2)Also, we plan to integrate a cortical stimulator (MS-120B, Nihon Kohden Corporation) and a switch box (MS-120B, Nihon Kohden Corporation), which uses computer software to switch electrodes to stimulate, in order to carry out cortical functional mapping more safely and efficiently (MS-210B and PE-210A have been approved under the Pharmaceutical Affairs Act in Japan.).

Registered date

2011

Year

09

Month

08

Day

Last modified on

2012

Year

09

Month

08

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007467