UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031253 |
|---|---|
| Receipt number | R000035685 |
| Scientific Title | Elucidation of the effect of short-term spinal cord stimulation therapy on resting state functional connectivity network |
| Date of disclosure of the study information | 2018/02/12 |
| Last modified on | 2025/02/21 00:14:42 |
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Basic information
Public title
Elucidation of the effect of short-term spinal cord stimulation therapy on resting state functional connectivity network
Acronym
the effect of short-term spinal cord stimulation therapy on resting state functional connectivity network
Scientific Title
Elucidation of the effect of short-term spinal cord stimulation therapy on resting state functional connectivity network
Scientific Title:Acronym
the effect of short-term spinal cord stimulation therapy on resting state functional connectivity network
Region
| Japan |
Condition
Condition
intractable pain in limbs
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Elucidation of the effect of short-term spinal cord stimulation therapy on resting state functional connectivity network
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
changes in resting functional connectivity before and after spinal cord stimulation therapy
Key secondary outcomes
correlation between changes in resting functional connectivity before and after spinal cord stimulation therapy and improvement of pain after treatment
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
spinal cord stimulation
magnetic resonance imaging
Interventions/Control_2
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
Men and women over 20 years old
Patients who have refractory extremity pain and receive treatment for SCS test stimulation
Those who obtain written agreement by voluntary free willingness concerning participation in this exam
Key exclusion criteria
have mental / neurological disorder now or in the past
Psychotropic medicine other than drug prescribed for pain is used
Patients with organic brain damage
Have equipment not compatible with MRI such as pacemaker in the body
Have metallic instruments / instruments not compliant with MRI such as arterial clips in the body
During pregnancy
claustrophobia
In addition, patients judged inappropriate by the person in charge of this study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Mizobuchi |
Organization
Kobe university graduate school of medicine/school of medicine
Division name
Anesthesiology
Zip code
Address
5-2, Kusunoki-cho7, Chuo-ku,Kobe-shi,Hyougo
TEL
078-382-6172
smizob@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Mizobuchi |
Organization
Kobe university graduate school of medicine/school of medicine
Division name
Anesthesiology
Zip code
Address
5-2, Kusunoki-cho7, Chuo-ku,Kobe-shi,Hyougo
TEL
078-382-6172
Homepage URL
smizob@med.kobe-u.ac.jp
Sponsor or person
Institute
Division of Anesthesiology, Department of Surgery Related,Kobe university graduate school of medicine
Institute
Department
Personal name
Funding Source
Organization
Division of Anesthesiology, Department of Surgery Related,Kobe university graduate school of medicine
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 12 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 01 | Month | 30 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 02 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 12 | Day |
Last modified on
| 2025 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035685
