UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005645 |
|---|---|
| Receipt number | R000006669 |
| Scientific Title | Evaluation of cerebral blood flow before and after acupuncture stimulation using arterial spin-labeled MRI for healthy adults |
| Date of disclosure of the study information | 2011/05/26 |
| Last modified on | 2023/12/05 17:59:27 |
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Basic information
Public title
Evaluation of cerebral blood flow before and after acupuncture stimulation using arterial spin-labeled MRI for healthy adults
Acronym
Japan Evaluation of cerebral blood flow before and after acupuncture stimulation using arterial spin-labeled MRI for healthy adults
JASCA study
Scientific Title
Evaluation of cerebral blood flow before and after acupuncture stimulation using arterial spin-labeled MRI for healthy adults
Scientific Title:Acronym
Japan Evaluation of cerebral blood flow before and after acupuncture stimulation using arterial spin-labeled MRI for healthy adults
JASCA study
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Under the concept that acupuncture being one of the traditional Asian medicines fostered over thousands of years contributes to alleviation of many diseases and symptoms not only through mere local reactions but also through the reactions of autonomic nerve system mediated by the high-level central nervous system and immunological/endocrine functions, we have investigated the influences of acupuncture on various body functions and on mainly painful affections.
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 Arterial Spin Labeled (ASL) as an index.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
cerebral blood flow
Key secondary outcomes
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
| Other |
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
Healthy adult
Key exclusion criteria
The subjects have history of cerebrovascular disorder
The primary headache in Version 2 of International Headache Classification.
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
saitama medical univercity IRB
Address
38 morohongo, irumagun,
Tel
049-276-2143
rinri@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://www.saitama-med.ac.jp/jsms/vol39/01/jsms39_039_040.pdf
Publication of results
Partially published
Result
URL related to results and publications
https://www.saitama-med.ac.jp/jsms/vol39/01/jsms39_039_040.pdf
Number of participants that the trial has enrolled
11
Results
Before acupuncture stimulation, cerebral blood flow in migraineurs was higher in the occipital lobe and right temporal lobe, and lower in the left temporal lobe and precuneus of the vertebral lobe, compared with healthy adults. Compared to healthy adults before acupuncture stimulation, blood flow in the thalamus, hypothalamus, valgus, cingulate gyrus, and insula increased after 5 and 10 minutes during acupuncture stimulation.
Results date posted
| 2023 | Year | 09 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
healthy adults.
Participant flow
11 out of 11 recruited participated.
Adverse events
none
Outcome measures
Arterial spin-labeled MRI
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 | 02 | Month | 26 | Day |
Anticipated trial start date
| 2011 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 12 | Day |
Date of closure to data entry
| 2012 | Year | 03 | Month | 12 | Day |
Date trial data considered complete
| 2012 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 08 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 05 | Month | 25 | Day |
Last modified on
| 2023 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006669
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| Registered date | File name |
| Research case data | |
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