UMIN-CTR Clinical Trial

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
Email	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
Email	kyokyon1985@yahoo.co.jp

Sponsor
Institute	Kobe University Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051165