UMIN-CTR Clinical Trial

Public title

Single Comparative Study of Magnetic
Stimulation for Neuropathic Pain

Acronym

Minamata Study

Scientific Title

Single Comparative Study Confirming the Effectiveness of Magnetic
Stimulation for Neuropathic Pain including Minamata Disease Patients

Scientific Title:Acronym

Minamata Study

Region

Japan

Condition

Neuropathic pain patients including Minamata disease

Classification by specialty

Neurology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Evaluation of the effect of Magnetic Stimulation Therapy on Neuropathic pain in Minamata diseases

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Amount of change of the mean VAS score for one week after the end of treatment from baseline VAS score*.
*Baseline VAS score : Mean VAS score performed for 1 week before treatment.

Key secondary outcomes

Amount of change of the mean VAS score for each week of 2nd, 3rd, and 4th week after the treatment from baseline VAS score.
Amount of change of the pain threshold in transcranial magnetic stimulation treatment at each time point (immediately after 5th day-treatment, 28 days after treatment).
Amount of change of the pain evaluation scale (SF-MPQ-2) at each time point (immediately after 5th day-treatment, 28 days after treatment).
Amount of change of Beck Depression Inventory (BDI) at each time point of (immediately after 5th day-treatment, 28 days after treatment).
Satisfaction with treatment (PGIC) at immediately after 5th day-treatment and 28 days after treatment.
Amount of change of VAS score from the pre-treatment value in the days during the treatment period (1st - 5th day).

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

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Using High Frequency Transcranial Magnetic Stimulator (MagPro X100, Mag Venture), magnetic stimulation therapy is performed a total of 5 times for 5 consecutive days.

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

50

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Age at the time of consent acquisition: 50 years old or older / Gender: No matter / ADL: Relatively maintained / Not excluded by TMS registration form / Neuropathic pain had been continuing for 6 months or more at the time of consent obtained / The average value of VAS for one week during the screening period is 4.0 or more / The VAS could be recorded for one week during the screening period

Key exclusion criteria

Those who cannot obtain written consent for this study / Those who meet the eligibility criteria but their attending physicians have determined that it is impossible for them to enrolled in the clinical study / Those with diabetic neuropathy / Those for whome 3T MRI examination cannot be performed / Those with cognitive decline (MMSE<24) / Pregnant or potentially pregnant

Target sample size

40

Name of lead principal investigator

1st name	Nakamura
Middle name
Last name	Masaaki

Organization

National Institute for Minamata Disease

Division name

Department of Clinical Medicine

Zip code

867-0008

Address

4058-18 Hama, Minamata-City, Kumamoto, Japan

TEL

0966-63-3111

Email

MASAAKI_NAKAMURA@env.go.jp

Name of contact person

1st name	Tabata
Middle name
Last name	Nobuko

Organization

National Institute for Minamata Disease

Division name

Department of Clinical Medicine

Zip code

867-0008

Address

4058-18 Hama, Minamata-City, Kumamoto, Japan

TEL

0966-63-3111

Homepage URL

Email

NOBUKO_TABATA@env.go.jp

Institute

National Institute for Minamata Disease

Institute

Department

Personal name

Organization

NMinistry of the Environment

Organization

Division

Category of Funding Organization

Government offices of other countries

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Kyushu University Certified Institutional Review Board for Clinical Trials

Address

WWW 6F-615,3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, JAPAN

Tel

092-642-5082

Email

byskenkyu@jimu.kyushu-u.ac.jp

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

2020

Year

06

Month

19

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

Terminated

Date of protocol fixation

2020

Year

03

Month

06

Day

Date of IRB

2020

Year

06

Month

23

Day

Anticipated trial start date

2020

Year

07

Month

01

Day

Last follow-up date

2023

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2020

Year

06

Month

12

Day

Last modified on

2022

Year

06

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046514