UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025975 |
|---|---|
| Receipt number | 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 | 2020/02/05 12:05:52 |
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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
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 Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028176
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