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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028222
Receipt No. 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 2017/07/13

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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
Email 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
Email ckckck_sumire@yahoo.co.jp

Sponsor
Institute University of Tsukuba, Mito medical center, Mito kyodo general hospital.
Institute
Department

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
Email

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 Open public recruiting
Date of protocol fixation
2017 Year 07 Month 07 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 07 Day
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
2017 Year 07 Month 13 Day
Last modified on
2017 Year 07 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032184

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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