UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031254
Receipt number 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 01:33:07

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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 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


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

Value
https://center6.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