UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000010536
Receipt number	R000012320
Scientific Title	Repetitive transcranial magnetic stimulation (rTMS) of primary motor cortex for intractable neuropathic pain: determination of the effect between 8 shaped coil and H-coil by consecutive rTMS and analysis of the mechanism
Date of disclosure of the study information	2013/04/19
Last modified on	2015/10/19 14:14:00

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Basic information

Public title

Repetitive transcranial magnetic stimulation (rTMS) of primary motor cortex for intractable neuropathic pain: determination of the effect between 8 shaped coil and H-coil by consecutive rTMS and analysis of the mechanism

Acronym

Scientific Title

Scientific Title:Acronym

Region

Japan

Condition

Intractable neuropathic pain

Classification by specialty

Neurology Neurosurgery Adult

Classification by malignancy

Others

Genomic information

Objectives

Narrative objectives1

Analysis of efficacy and safety of repetitive transcraanial magnetic stimulation, between 8 shaped coil and H-coil for intractable neuropathic pain

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Assessment

Primary outcomes

VAS (Visual analogue scale)

Key secondary outcomes

SF-MPQ 2(Short form of McGill pain questionnaire2)
patient global impression of change scale(PGIC)
Beck depression inventory(BDI)

Base

Study type

Interventional

Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

Institution consideration

Blocking

Concealment

Intervention

No. of arms

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Repetitive transcranial magnetic stimulation of H-coil

Interventions/Control_2

Repetitive transcranial magnetic stimulation of 8 shaped coil

Interventions/Control_3

Sham stimulation

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

20 years-old <=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

(1) Intractable neuropathic pain for 6 months
(2)Patients who consented to keep drug and living conditions during the study
(3) No cognitive disorders, aphasia, psychiatric disorder, higher brain dysfunction
(4) the patients who can write questionare
(5) over 20 years old
(6) Those who give us informed consent to participate in the present study after detailed explanation of the study

Key exclusion criteria

(1) No implantation of metal in head, except in the mouth
(2) Those having heart pacemaker or drug infusion pomp
(3) Those having heart pacemaker or severe heart diseases
(4) Those having the deep brain stimulation or the spinal cord stimulation
(5)Major cerebral infarction, head traum, epilepsy, brain tumor
(6) Pregnant or intend to be pregnant
(7) the patients who are excluded by doctors

Target sample size

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name Youichi Saitoh

Organization

Osaka university

Division name

Department of Neuromodulation and Neurosurgery,Office forUniversity-Industry Collaboration

Zip code

Address

2-1 Yamadaoka, Suita, Osaka

TEL

+81-6-6879-4138

Email

neurosaitoh@mbk.nifty.com

Public contact

Name of contact person

1st name

Middle name

Last name Takeshi Shimizu

Organization

Osaka university

Division name

Department of Neuromodulation and Neurosurgery,Office forUniversity-Industry Collaboration

Zip code

Address

2-1 Yamadaoka, Suita, Osaka

TEL

+81-6-6879-4138

Homepage URL

Email

Takeshi.Shimizu32@gmail.com

Sponsor or person

Institute

Osaka University, Department of Neuromodulation and Neurosurgery,Office forUniversity-Industry Collaboration

Institute

Department

Personal name

Funding Source

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Other related organizations

Co-sponsor

Name of secondary funder(s)

IRB Contact (For public release)

Organization

Address

Tel

Email

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2013 Year 04 Month 19 Day

Related information

URL releasing protocol

Publication of results

Partially published

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

Completed

Date of protocol fixation

2013 Year 04 Month 18 Day

Date of IRB

Anticipated trial start date

2013 Year 04 Month 19 Day

Last follow-up date

2015 Year 02 Month 01 Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

2015 Year 12 Month 31 Day

Other

Other related information

Management information

Registered date

2013 Year 04 Month 18 Day

Last modified on

2015 Year 10 Month 19 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012320

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name