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

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 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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name