UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003048 |
|---|---|
| Receipt number | R000003020 |
| Scientific Title | Multicenter study of repetitive transcranial magnetic stimulation (rTMS) of primary motor cortex for intractable neuropathic pain: determination of the effect by consecutive rTMS and analysis of the mechanism |
| Date of disclosure of the study information | 2010/01/17 |
| Last modified on | 2012/04/14 08:36:13 |
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Basic information
Public title
Multicenter study of repetitive transcranial magnetic stimulation (rTMS) of primary motor cortex for intractable neuropathic pain: determination of the effect by consecutive rTMS and analysis of the mechanism
Acronym
Treatment of neuropathic pain with consecutive rTMS
Scientific Title
Multicenter study of repetitive transcranial magnetic stimulation (rTMS) of primary motor cortex for intractable neuropathic pain: determination of the effect by consecutive rTMS and analysis of the mechanism
Scientific Title:Acronym
Treatment of neuropathic pain with consecutive rTMS
Region
| Japan |
Condition
Condition
Intractable neuropathic pain
Classification by specialty
| Neurology | Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Analysis of efficacy and safety of repetitive transcraanial magnetic stimulation of primary motor cortex for intractable neuropathic pain
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual analogue scale
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
real repetitive transcranial magnetic stimulation
Interventions/Control_2
sham stimulation
Interventions/Control_3
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) the patients who agree with no change of drugs during trial
(3) No cognitive disorders, aphasia, psychiatric disorder, higher brain dysfunction or desire for suicide
(4) the patients who can write questionare
(5) over 20 years old
(6) informed consent
Key exclusion criteria
(1) metal implant on the head
(2) heart pacing, drug infusion pump
(3) severe heart diseases
(4) Major cerebral infarction, head traum, epilepsy, brain tumor
(5) pregnancy
(6) the patients who was excluded by doctors
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Youichi saitoh |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Neurosurgery
Zip code
Address
Yamadaoka 2-2, Suita, Osaka 565-0871
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Neurosurgery
Zip code
Address
TEL
Homepage URL
saitoh@nsurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Neuromodulation and Neurosurgery, Osaka University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2010 | Year | 01 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
| 2009 | Year | 05 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 01 | Month | 17 | Day |
Last modified on
| 2012 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003020
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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