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