UMIN-CTR Clinical Trial

Basic information
Public title	A Study on Determining the Causes of Migraine by Measuring Cervical Muscle Activities Using a Wearable Electromyograph
Acronym	Measurement of Cervical Muscle Activities Using a Wearable Electromyograph
Scientific Title	A Study on Determining the Causes of Migraine by Measuring Cervical Muscle Activities Using a Wearable Electromyograph
Scientific Title:Acronym	Measurement of Cervical Muscle Activities Using a Wearable Electromyograph
Region	Japan

Condition
Condition	Migraine
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Since muscle activity is a biological signal that can be measured in daily life and is also the final output of the nervous system, muscle activity may be a window to the nervous system. We have measured characteristic painful myoelectric signals from cervical muscle activity in migraine patients, which appear to be irregular activity caused by involuntary reflex movements. These signals indicate that myoelectricity is likely to contain not only forces that drive joints, but also signals that indicate the state or abnormality of the nervous system. In this study, we aim to clarify the relationship between headache attacks and pain myoelectricity in migraine patients to elucidate the mechanism of migraine attacks, and show that estimating neural activity from muscle activity analysis is useful for investigating and quantifying the cause of disease. These discussions will lead to patient-participatory medicine in which patients measure their own biological signals on a daily basis and understand their individual health status as changes in these signals. The purpose of this study is to demonstrate the usefulness of daily bio-signal measurement and monitoring for health maintenance, and to identify engineering, theoretical, and medical problems by reducing the problem to a concrete one of the relationship between migraine and cervical muscle activity and speeding up system development.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	- Difference of cervical muscle activity amplitude between in normal state and in migraine attack - Difference of muscle synergy of cervical muscles between in normal state and in migraine attack - Difference of frequency of cervical muscle activities between in normal state and in migraine attack
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
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Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients with stable general health, baseline migraine attacks of at least 2 on 4-14 days per month, regular visits to headache outpatient clinic, and appropriate headache diary entries
Key exclusion criteria	Those with metal allergies Those with abnormal skin conditions
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Shingo Middle name Last name Shimoda
Organization	RIKEN
Division name	Center of Brain Science
Zip code	463-0003
Address	2271-130 Shimo-Shidami Moriyama-ku Nagoya, Aichi
TEL	052-736-5861
Email	shingo.shimoda@riken.jp

Public contact
Name of contact person	1st name Shingo Middle name Last name Shimoda
Organization	RIKEN
Division name	Center of Brain Science
Zip code	463-0003
Address	2271-130 Shimo-Shidami Moriyama-ku Nagoya, Aichi
TEL	052-736-5861
Homepage URL
Email	shingo.shimoda@riken.jp

Sponsor
Institute	RIKEN
Institute
Department

Funding Source
Organization	Japan Science and Technology Agency
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	RIKEN
Address	2-1 Hirosawa Wako-shi, Saitama
Tel	048-462-1111
Email	human@riken.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	2021 Year 11 Month 11 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	Preinitiation
Date of protocol fixation	2021 Year 09 Month 15 Day
Date of IRB	2021 Year 10 Month 14 Day
Anticipated trial start date	2021 Year 11 Month 11 Day
Last follow-up date	2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	tentative

Management information
Registered date	2021 Year 11 Month 08 Day
Last modified on	2021 Year 11 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052512