UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005644
Receipt number R000006668
Scientific Title Evaluation of cerebral blood flow before and after acupuncture stimulation using arterial spin-labeled MRI for migraine -uncontrolled, open label study-
Date of disclosure of the study information 2011/05/26
Last modified on 2020/11/09 17:35:04

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Basic information

Public title

Evaluation of cerebral blood flow before and after acupuncture stimulation using arterial spin-labeled MRI for migraine
-uncontrolled, open label study-

Acronym

Japan Evaluation of cerebral blood flow before and after acupuncture stimulation using arterial spin-labeled MRI for migraine
JASCA study

Scientific Title

Evaluation of cerebral blood flow before and after acupuncture stimulation using arterial spin-labeled MRI for migraine
-uncontrolled, open label study-

Scientific Title:Acronym

Japan Evaluation of cerebral blood flow before and after acupuncture stimulation using arterial spin-labeled MRI for migraine
JASCA study

Region

Japan


Condition

Condition

migaraine

Classification by specialty

Neurology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

In the update report of Cochrane review analyzing it has not yet been verified whether acupuncture is more useful than fake acupuncture (placebo), but in comparison with the efficacy-established preventive drug therapy, it was concluded that acupuncture is equivalent to or slightly more effective than the preventive drug therapy and induces less adverse events. We investigated the onset mechanism of tension-type headache and the action mechanism of acupuncture using plethysmography, EMG, thermography and open loop video pupillography. As a result, it was found that the hypertension of the posterior cervical, suprascapular and interscapular muscles play more important roles than the hypertension of the head muscles in the onset mechanism of headache, and acupuncture contributes to alleviation of headache by relaxing the hypertension of these muscles and normalizing the circulatory dynamics. It was further clarified that such analgesic mechanism has influences not only on the local reaction (axonal reflex) but also on the high-level central nervous system (Edinger-Westphal Nucleus / periaqueductal gray matter) and the autonomic nerve system is playing important roles.
Then, in this study, for the purpose of clarifying the mechanism of acupuncture against migraine, we will investigate the influences of acupuncture on the cerebral blood flow at the pain-sensitive sites of thalamus, hypothalamus, periaqueductal gray matter, ceruleus nucleus, nucleus raphe magnus, etc., which are considered to be the migraine-inducing organs, by determining the cerebral blood flow changes using ASL as an index

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

cerebral blood flow

Key secondary outcomes

Headache diary


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

Maneuver

Interventions/Control_1

acupuncture

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

18 years-old <=

Age-upper limit

65 years-old >=

Gender

Male and Female

Key inclusion criteria

Migraine headache of the diplomatic relations verge headache classification second edition

Key exclusion criteria

The subjects have history of cerebrovascular disorder

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Satoru
Middle name
Last name Yamaguchi

Organization

Saitama Medical University

Division name

The Center for Oriental and Integrated Medicine,Saitama Medical University, Saitama, Japan.

Zip code

350-0495

Address

38,Morohongo,Moroyamamachi,Iruma-gun,Saitama

TEL

+81-(0)49-276-1274

Email

sayama@saitama-med.ac.jp


Public contact

Name of contact person

1st name Satoru
Middle name
Last name Yamaguchi

Organization

Saitama Medical University

Division name

The Center for Oriental and Integrated Medicine,Saitama Medical University, Saitama, Japan.

Zip code

350-0495

Address

38,Morohongo,Moroyamamachi,Iruma-gun,Saitama

TEL

+81-(0)49-276-1274

Homepage URL

http://www.saitama-med.ac.jp/hospital/division_info/26.html

Email

sayama@saitama-med.ac.jp


Sponsor or person

Institute

Saitama Medical University

Institute

Department

Personal name



Funding Source

Organization

Saitama Medical University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

IRBl ,Saitama Medical University, Saitama, Japan.

Address

38,Morohongo,Moroyamamachi,Iruma-gun,Saitama

Tel

049-276-1354

Email

hirb@saitama-med.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

2011 Year 05 Month 26 Day


Related information

URL releasing protocol

https://touyouigakuka.wixsite.com/touyou-2/blank-7

Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

20

Results

The target cases are 11 patients with migraine (4 males and 7 females) and 11 healthy adults (6 males and 4 females).

Results date posted

2019 Year 06 Month 10 Day

Results Delayed

Delay expected

Results Delay Reason

Because the analysis is delayed

Date of the first journal publication of results


Baseline Characteristics

migraine

Participant flow

Open call for participants
Diagnosis by a specialist
Inform outlet
Cerebral blood flow evaluation

Adverse events

none

Outcome measures

Cerebral blood flow

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2010 Year 09 Month 01 Day

Date of IRB

2011 Year 07 Month 23 Day

Anticipated trial start date

2011 Year 07 Month 22 Day

Last follow-up date

2013 Year 03 Month 31 Day

Date of closure to data entry

2014 Year 03 Month 31 Day

Date trial data considered complete

2014 Year 03 Month 31 Day

Date analysis concluded

2014 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2011 Year 05 Month 25 Day

Last modified on

2020 Year 11 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006668


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name