UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000777 |
|---|---|
| Receipt number | R000000906 |
| Scientific Title | Therapy for intractable deafferentation pain with navigation-guided repetitive transcranial magnetic stimulation |
| Date of disclosure of the study information | 2007/07/27 |
| Last modified on | 2012/04/14 08:39:21 |
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Basic information
Public title
Therapy for intractable deafferentation pain with navigation-guided repetitive transcranial magnetic stimulation
Acronym
Therapy for deafferentation pain with repetitive transcranial magnetic stimulation
Scientific Title
Therapy for intractable deafferentation pain with navigation-guided repetitive transcranial magnetic stimulation
Scientific Title:Acronym
Therapy for deafferentation pain with repetitive transcranial magnetic stimulation
Region
| Japan |
Condition
Condition
intractable deafferentation pain
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Analysis of the pain reduction of intractable deafferentation pain with repetitive transcranial magnetic stimulation (5Hz, 1500 times)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
visual analogue scale
Key secondary outcomes
SF-McGill Pain Questionare
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Pain relief is analysed for 2 weeks after repetitive transcranial magnetic stimulation(5Hz 10sec for 50sec interval, 30 times, 90% of resting motor thershold). Three cosecutive trials.
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
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The patients with drug-resistant (intractable) deafferentation pain for more than 6 months
Key exclusion criteria
The patients with history of convulsion, with unraptured aneurysm, with heart pacer, with brain stimulation device, and whom the physicians considered not to fit for this research trial.
Target sample size
30
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
2-2 Yamadaoka, Suita, Osaka
TEL
06-6879-3652
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
2-2 Yamadaoka, Suita, Osaka
TEL
Homepage URL
Sponsor or person
Institute
Osaka University Medical Hospital
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid from Ministry of Education, Culture, Sports, Science and Technology
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
| 2007 | Year | 07 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
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
| 2005 | Year | 02 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2007 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2007 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2007 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2007 | Year | 11 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 07 | Month | 26 | 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=R000000906
| 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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| Registered date | File name |
