UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028222 |
|---|---|
| Receipt number | R000032184 |
| Scientific Title | The investigation of pathophysiology of migraine and mechanisms of acupuncture using Advanced-MRI. And the application for diagnosis. |
| Date of disclosure of the study information | 2017/07/14 |
| Last modified on | 2022/10/21 12:58:24 |
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Basic information
Public title
The investigation of pathophysiology of migraine and mechanisms of acupuncture using Advanced-MRI. And the application for diagnosis.
Acronym
The investigation of pathophysiology of migraine and mechanisms of acupuncture using Advanced-MRI
Scientific Title
The investigation of pathophysiology of migraine and mechanisms of acupuncture using Advanced-MRI. And the application for diagnosis.
Scientific Title:Acronym
The investigation of pathophysiology of migraine and mechanisms of acupuncture using Advanced-MRI
Region
| Japan |
Condition
Condition
Migraine without aura
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We perform EAP-C2-PNfS for the patients with migraine without aura, and emamine Advanced-MRI before and after acupuncture.
We examine MRI findings of patients and healthy controls.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Headache Impact Test (HIT-6): initials and 3 months later.
Key secondary outcomes
Numerical rating scale (NRS)
Short-form 36 (SF-36)
Self-rating depression scale (SDS)
Neurite Orientation Dispersion and Density Imaging (NODDI)
Resting state functional MRI (rsfMRI)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Acupuncture once a week for 3 months.
Interventions/Control_2
Healthy control
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Subjects must satisfy the following conditions for inclusion
1.Migraine without aura
2.Understand the explanation of the experiment and express consent.
Key exclusion criteria
1. Neurological deficit and/or intracranial abnormality.
2. Having acupuncture therapy now
3. Pregnant
4. Perticipating another clinical trials"
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasushi Shibata |
Organization
University of Tsukuba, Mito medical center, Mito kyodo general hospital.
Division name
Department of Neurosurgery
Zip code
Address
3-2-7, Miyamachi, Mito, Ibaraki
TEL
029-231-2371
yshibata@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sumire Ishiyama |
Organization
University of Tsukuba
Division name
Graduate School of Comprehensive Human Sciences, Doctoral Program in Clinical Sciences
Zip code
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
029-231-2371
Homepage URL
ckckck_sumire@yahoo.co.jp
Sponsor or person
Institute
University of Tsukuba, Mito medical center, Mito kyodo general hospital.
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the promotion of science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 07 | Month | 14 | 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
Completed
Date of protocol fixation
| 2017 | Year | 07 | Month | 07 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 07 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 07 | Month | 13 | Day |
Last modified on
| 2022 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032184
