UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044799 |
|---|---|
| Receipt number | R000051165 |
| Scientific Title | Effects of Different Stimulation Methods of Short-Term Spinal Cord Stimulation Therapy Effects of Different Stimulation Methods on Resting Brain Functional Connectivity Changes |
| Date of disclosure of the study information | 2021/08/16 |
| Last modified on | 2021/07/08 16:26:59 |
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Basic information
Public title
Effects of Different Stimulation Methods of Short-Term Spinal Cord Stimulation Therapy
Effects of Different Stimulation Methods on Resting Brain Functional Connectivity Changes
Acronym
Effects of Different Stimulation Methods of Short-Term Spinal Cord Stimulation Therapy
Effects of Different Stimulation Methods on Resting Brain Functional Connectivity Changes
Scientific Title
Effects of Different Stimulation Methods of Short-Term Spinal Cord Stimulation Therapy
Effects of Different Stimulation Methods on Resting Brain Functional Connectivity Changes
Scientific Title:Acronym
Effects of Different Stimulation Methods of Short-Term Spinal Cord Stimulation Therapy
Effects of Different Stimulation Methods on Resting Brain Functional Connectivity Changes
Region
| Japan |
Condition
Condition
Chronic intractable neuropathic pain
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the differences in changes in functional connectivity between brain regions before and after stimulation in those who benefit from low-dose stimulation (LD group) and those who benefit from high-dose stimulation (HD group).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Differential changes in functional connectivity of brain regions
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
high dose stimulation group
Interventions/Control_2
low dose stimulation group
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Males and females aged 20 years and older
(2) Patients with intractable neuropathic pain, such as postherpetic neuralgia, failed back surgery syndrome (FBSS), complex regional pain syndrome (CRPS), and other peripheral neuropathic pain:
(3) Patients who have chronic pain (subacute to chronic) for more than one month with intractable pain that is resistant to treatment and whose physician considers treatment with SCS test stimulation necessary.
(4) Patients who have freely given written consent to participate in the study.
Key exclusion criteria
(1) Current or past psychiatric or neurological disorders
(2) Using psychotropic drugs other than those prescribed for pain
(3) Patients with organic brain damage.
(4) Patients with non-MRI devices such as pacemakers in the body
(5) Patients with metal devices such as arterial clips in the body
(6) Pregnant
(7) Claustrophobia
(8) Other patients who have contraindications to spinal cord stimulation therapy or other conditions deemed inappropriate by the study investigators.
Target sample size
46
Research contact person
Name of lead principal investigator
| 1st name | SATOSHI |
| Middle name | |
| Last name | MIZOBUCHI |
Organization
Kobe University School of Medicine
Division name
Department of Surgery, Graduate School of Medicine, Kobe University
Zip code
650-0017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL
078-382-6172
anesth@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | KYOHEI |
| Middle name | |
| Last name | UENO |
Organization
Kobe University School of Medicine
Division name
Department of Surgery, Graduate School of Medicine, Kobe University
Zip code
650-0017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL
078-382-6172
Homepage URL
kyokyon1985@yahoo.co.jp
Sponsor or person
Institute
Kobe University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kobe University Hospital
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
Kobe University Hospital
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Japan
Tel
078-382-6172
anesth@med.kobe-u.ac.jp
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
| 2021 | Year | 08 | Month | 16 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 07 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 08 | Month | 16 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 07 | Month | 08 | Day |
Last modified on
| 2021 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051165
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| Registered date | File name |
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| Registered date | File name |
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