UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000031254
Receipt No. R000035686
Scientific Title Elucidation of the effect of ketamine on resting state functional connectivity network in chronic pain patients
Date of disclosure of the study information 2018/02/12
Last modified on 2018/02/12

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Elucidation of the effect of ketamine on resting state functional connectivity network in chronic pain patients
Acronym Elucidation of the effect of ketamine on resting state functional connectivity network in chronic pain patients
Scientific Title Elucidation of the effect of ketamine on resting state functional connectivity network in chronic pain patients
Scientific Title:Acronym Elucidation of the effect of ketamine on resting state functional connectivity network in chronic pain patients
Region
Japan

Condition
Condition chronic pain
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Elucidation of the effect of ketamine on resting state functional connectivity network in chronic pain patients
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 Ketamine therapy
Key secondary outcomes correlation between changes in resting functional connectivity before and after Ketamine 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
Medicine
Interventions/Control_1 infusion of Ketamine
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 chronic pain of more than 6 months and who have difficulty in pain control by treatment of nerve blocks or medications and who want treatment with ketalar
Those who obtain document consent by their voluntary freedom about participation in this exam
Key exclusion criteria Present or past mental / neurological diseases
I use psychotropic drugs other than drugs prescribed for pain
Patients with organic brain injury
MRI non-compliant equipment such as pacemaker in the body
Have metallic instruments / instruments not compliant with MRI such as arterial clips in the body
Pregnant
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
Email 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
Email smizob@med.kobe-u.ac.jp

Sponsor
Institute Division of Anesthesiology, Department of Surgery Related,Kobe university graduate school of medicine
Institute
Department

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
Email

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 Preinitiation
Date of protocol fixation
2018 Year 01 Month 30 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 01 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
2018 Year 02 Month 12 Day
Last modified on
2018 Year 02 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035686

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.