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
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
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
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
