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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010536
Receipt No. 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

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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 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
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
Scientific Title:Acronym 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
Region
Japan

Condition
Condition Intractable neuropathic pain
Classification by specialty
Neurology Neurosurgery Adult
Classification by malignancy Others
Genomic information NO

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 3
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 20

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

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
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
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
URL(English) https://upload.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


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