UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013608 |
|---|---|
| Receipt number | R000015894 |
| Scientific Title | The contraction and management of the cooperative shared system between the multiple fixed research institutions for the investigation of the biomarker and dimension of many kinds of metal disorders |
| Date of disclosure of the study information | 2014/04/02 |
| Last modified on | 2014/04/02 11:47:19 |
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Basic information
Public title
The contraction and management of the cooperative shared system between the multiple fixed research institutions for the investigation of the biomarker and dimension of many kinds of metal disorders
Acronym
The contraction and management of the cooperative shared system between the multiple fixed research institutions for the investigation of the biomarker and dimension of many kinds of metal disorders
Scientific Title
The contraction and management of the cooperative shared system between the multiple fixed research institutions for the investigation of the biomarker and dimension of many kinds of metal disorders
Scientific Title:Acronym
The contraction and management of the cooperative shared system between the multiple fixed research institutions for the investigation of the biomarker and dimension of many kinds of metal disorders
Region
| Japan |
Condition
Condition
intractable neuropathic pain
Classification by specialty
| Medicine in general | Neurology | Psychosomatic Internal Medicine |
| Psychiatry | Orthopedics | Anesthesiology |
| Neurosurgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of the brain imaging biomarkers of intractable neuropathic pain using fMRI and MEG
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Functional connectivity
SF-MPQ2(Short form of McGill pain questionnaire2)
VAS(Visual analogue scale)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Other |
Interventions/Control_1
Neurofeedback
Interventions/Control_2
Sham feedback
Interventions/Control_3
rTMS(repetitive transcranial magnetic stimulation)
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Intractable neuropathic pain for 6 months
(2)Patients who consented to keep drug and living conditions during the study
(3) No cognitive disorders, aphasia, psychiatric disorder, higher brain dysfunction
(4) the patients who can write questionare
(5) over 20 years old
(6) Those who give us informed consent to participate in the present study after detailed explanation of the study
Key exclusion criteria
Patients wear devices that are susceptable to high magnetic field of the MRI.
(1) Pacemaker for heart diseases
(2) Clip for aneurysms
(3) Deep brain stimulation or spinal cord stimulation
(4) Drug infusion pomp
(5) Implantation of metal in head, except in the mouth
(6) Pregnant or intend to be pregnant
(7) Tattoo or eye line
Target sample size
15
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
TEL
+81-6-6879-8435
neurosaitoh@mbk.nifty.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Shmizu |
Organization
Osaka University
Division name
Department of Neurosurgery
Zip code
Address
2-2 Yamadaoka, Suita, Osaka
TEL
+81-6-6879-3652
Homepage URL
takeshi.shimizu32@gmail.com
Sponsor or person
Institute
Osaka University, Department of Neuromodulation and Neurosurgery
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
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
| 2014 | Year | 04 | Month | 02 | 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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 03 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 03 | Month | 05 | 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
| 2014 | Year | 04 | Month | 02 | Day |
Last modified on
| 2014 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015894
