UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046006 |
|---|---|
| Receipt number | R000052512 |
| Scientific Title | A Study on Determining the Causes of Migraine by Measuring Cervical Muscle Activities Using a Wearable Electromyograph |
| Date of disclosure of the study information | 2021/11/11 |
| Last modified on | 2021/11/08 09:56:43 |
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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
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
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
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
shingo.shimoda@riken.jp
Sponsor or person
Institute
RIKEN
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052512
