UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020291 |
|---|---|
| Receipt number | R000022598 |
| Scientific Title | Analysis of efficacy and safety of the stimulation of primary motor cortex with rTMS (TEN-P11) in the intractable neuropathic pain |
| Date of disclosure of the study information | 2015/12/25 |
| Last modified on | 2018/05/01 17:41:07 |
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Basic information
Public title
Analysis of efficacy and safety of the stimulation of primary motor cortex with rTMS (TEN-P11) in the intractable neuropathic pain
Acronym
Analysis of efficacy and safety of rTMS(TEN-P11) of primary motor cortex in the intractable neuropathic pain
Scientific Title
Analysis of efficacy and safety of the stimulation of primary motor cortex with rTMS (TEN-P11) in the intractable neuropathic pain
Scientific Title:Acronym
Analysis of efficacy and safety of rTMS(TEN-P11) of primary motor cortex in the intractable neuropathic pain
Region
| Japan |
Condition
Condition
Intractable neuropathic pain
Classification by specialty
| Neurology | Orthopedics | Anesthesiology |
| Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Confirmation of pain reduction with rTMS of primary motor cortex using TEN-P11 for intractable neuropathic pain in comparison with sham stimulation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
VAS reduction from baseline (i.e. before the intervention on the first day) just after the intervention
Key secondary outcomes
Pain reduction rate in VAS
Pain reduction and pain reduction rate of VAS in short term
Pain reduction and pain reduction rate of VAS just before intervention
Reduction and reduction rate of SF-MPQ2
Reduction and reduction rate of SF-MPQ2 in short term
Reduction and reduction rate of SF-MPQ2 just before intervention
Amount and rate of change in the QOL score of EQ-5D-5L
Amount and rate of change in the visual analogue scale of EQ-5D-5L
Rate of subjects with 10mm VAS reduction or more
Rate of subjects with 20mm VAS reduction or more
Rate of subjects with 15% VAS reduction rate or more
Rate of subjects with 30% VAS reduction rate or more
Rate of subjects showing "minimally improved" or more in PGIC
Rate of subjects showing "much improved" or more in PGIC
Rate of subjects showing 5 points or more improvement in BDI-II
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Active stimulation (primary motor cortex) for 5 days
The patients who fulfil the required conditions receive active stimualtions in the extension period (once a week or more)
Interventions/Control_2
Sham stimulation for 5 days
The patients who fulfil the required conditions receive active stimualtions in the extension period (once a week or more)
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)Patients with intractable neuropathic pain for 6 months or longer
2)Patients with 30-94 mm in VAS at baseline
3)Patients with insufficient pain relief, despite receiving drugs for neuropathic pain, or a history of using more than a drug for neuropathic pain
4)Patients with continuous pain in extremities or face
5)Patients with an informed consent given
Key exclusion criteria
1)Patients with dementia (MMSE=<24)
2)Patients with severe aphasia or higher brain dysfunction
3)Patients with a major psychiatric disease
4)Patients with a desire for suicide
5)Patients with a history of epileptic attacks
6)Patients with an implantable stimulator including a cardiac pacemaker, except an impantable spinal cord stimulator
7)Patients with an implanted metal, except for titanium products, in their heads
8)Patients with an implanted pump or mechanical heart
8)Patients who cannot write questionaires
9)Patients showing complete paralysis in painful evaluation area
10)Patients without ability of agreements
11)Patients receiving rTMS within a year before agreements
12)Patients receiving other clinical trials or studies within 6 months before agreements
13)Compliance of patients for prohibited drugs and treatments is under 80%
14)Patients who are considered unsuitable for this clinical trial by a principal or sub investigator
Target sample size
144
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
Zip code
Address
2-2 Yamadaoka, Suita, Osaka 565-0871, Japan
TEL
+81-6-6210-8435
saitoh@nsurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koichi Hosomi |
Organization
Osaka University
Division name
Department of Neuromodulation and Neurosurgery
Zip code
Address
2-2 Yamadaoka, Suita, Osaka 565-0871, Japan
TEL
+81-6-6210-8435
Homepage URL
k-hosomi@nsurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Medical Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2015 | Year | 12 | Month | 25 | 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
| 2015 | Year | 12 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2017 | Year | 09 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2018 | Year | 02 | Month | 21 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 21 | Day |
Last modified on
| 2018 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022598
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