UMIN-CTR Clinical Trial
| Recruitment status | Completed |
| Unique ID issued by UMIN | UMIN000005644 |
| Receipt No. | 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 (Ver. 5) |
* 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 | 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 |
|
|
| Condition | ||
| Condition | migaraine | |
| Classification by specialty |
|
|
| 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 |
|
|
| 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 |
|
|||
| Age-upper limit |
|
|||
| 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 |
|
||||||
| 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 |
|
||||||
| 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 | |
| Institute | Saitama Medical University |
| Institute | |
| Department | |
| 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 |
|
||||||
| 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 |
|
||||||
| Results Delayed |
|
||||||
| 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 |
|
||||||
| Date of IRB |
|
||||||
| Anticipated trial start date |
|
||||||
| 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 |
|
||||||
| Last modified on |
|
||||||
| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006668 |
