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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025975
Receipt No. R000028176
Scientific Title Exploratory study of optimal conditions of non-invasive brain stimulation for intractable pain
Date of disclosure of the study information 2017/03/01
Last modified on 2019/02/04

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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 No longer recruiting
Date of protocol fixation
2017 Year 02 Month 02 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 01 Day
Last follow-up date
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
2019 Year 02 Month 04 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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