UMIN-CTR Clinical Trial

Basic information
Public title	Exploratory study of optimal conditions of non-invasive brain stimulation for intractable pain
Acronym	Exploratory study of optimal conditions of non-invasive brain stimulation for intractable pain
Scientific Title	Exploratory study of optimal conditions of non-invasive brain stimulation for intractable pain
Scientific Title:Acronym	Exploratory study of optimal conditions of non-invasive brain stimulation for intractable pain
Region	Japan

Condition
Condition	intractable pain
Classification by specialty	Neurology Anesthesiology Neurosurgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To explore optimal conditions of non-invasive brain stimualtion for treating intractable pain, and to investigate safety and feasibility of the long-term application
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Pain reduction in VAS Pain reduction in NRS
Key secondary outcomes	Frequency and duration of shooting pain, if a subject has a shooting pain Pain reduction in SF-MPQ 2 (Short form of McGill pain questionnaire 2) PGIC (Patient global impression of change) Improvement in PDAS (Pain Disability Assessment Scale) Improvement in EQ-5D Improvement in PCS (Pain Catastrophizing Scale) Improvement in HADS (Hospital Anxiety and Depression Scale) Change in BDI-II

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	6
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Active rTMS, condition 1 single session
Interventions/Control_2	Active rTMS, condition 2 single session
Interventions/Control_3	Active rTMS, condition 3 single session
Interventions/Control_4	Sham rTMS single session
Interventions/Control_5	Active tDCS single session
Interventions/Control_6	Sham tDCS single session
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 pain for 6 months or longer 2)Patients with 30mm or more in VAS at baseline 3)Patients with insufficient pain relief, despite receiving drugs for pain, or a history of using drugs for pain 4)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 cardiac stimulator 7)Patients with an implantable deep brain stimulation devices 8)Patients with an implanted metal in their heads, except for titanium products 9)Pregnant patients 10)Patients who cannot write questionaires 11)Patients without ability of agreements 12)Patients receiving other clinical trials or studies within 6 months before agreements 13)Patients who are considered unsuitable for this clinical trial by a principal or sub investigator 14)Patients with a scalp lesion on the stimulation site (tDCS)
Target sample size	50

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
Email	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
Email	k-hosomi@nsurg.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University Hospital
Institute
Department

Funding Source
Organization	Osaka University, Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	大阪大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2017 Year 03 Month 01 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	2017 Year 02 Month 02 Day
Date of IRB	2017 Year 02 Month 15 Day
Anticipated trial start date	2017 Year 03 Month 01 Day
Last follow-up date	2019 Year 03 Month 29 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 02 Month 02 Day
Last modified on	2020 Year 02 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028176

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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