UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Analysis of efficacy and safety of the stimulation of primary motor cortex with rTMS (TEN-P11) in the intractable neuropathic pain
Title of the study (Brief title)	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	Youichi Saitoh
Organization	Osaka University
Division name	Department of Neuromodulation and Neurosurgery
Address	2-2 Yamadaoka, Suita, Osaka 565-0871, Japan
TEL	+81-6-6210-8435
Email	saitoh@nsurg.med.osaka-u.ac.jp

Public contact
Name of contact person	Koichi Hosomi
Organization	Osaka University
Division name	Department of Neuromodulation and Neurosurgery
Address	2-2 Yamadaoka, Suita, Osaka 565-0871, Japan
TEL	+81-6-6210-8435
Homepage URL
Email	k-hosomi@nsurg.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University Medical Hospital
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 12 Month 22 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022598