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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033333
Receipt No. R000038001
Scientific Title The prospective study of the preventive effect of supraorbital transcutaneous stimulation using the Cefaly(R) device against frequent episodic migraine and chronic migraine
Date of disclosure of the study information 2018/07/10
Last modified on 2018/07/09

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Basic information
Public title The prospective study of the preventive effect of supraorbital transcutaneous stimulation using the Cefaly(R) device against frequent episodic migraine and chronic migraine
Acronym The prospective study of the preventive effect of supraorbital transcutaneous stimulation using the Cefaly(R) device against frequent episodic migraine and chronic migraine
Scientific Title The prospective study of the preventive effect of supraorbital transcutaneous stimulation using the Cefaly(R) device against frequent episodic migraine and chronic migraine
Scientific Title:Acronym The prospective study of the preventive effect of supraorbital transcutaneous stimulation using the Cefaly(R) device against frequent episodic migraine and chronic migraine
Region
Japan

Condition
Condition Migraine with and without aura, including chronic migraine (ICHD-3beta 1.1, 1.2.1, or 1.3)
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the preventive effect of supraorbital transcutaneous stimulation using the Cefaly(R) device against frequent episodic migraine and chronic migraine in Japan.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The decrease of migraine days after 12 weeks of treatment from run-in phase
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Stimulation to the forehead using Cefaly(R) device with a pulse width of 300 micro-sec, frequency of 60 Hz, and maximum electric current of 16 mA for 20 minutes every 24h for 12 weeks.
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
18 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria Migraine with and without aura, including chronic migraine (ICHD-3beta 1.2.1, 1.1, or 1.3), and at least 2 attacks and 4 days of migraine days per month.

The subjects who are using acute medicine and/or prophylactic medicine without changing the prescription for the last three months

The subjects whom informed consent has been obtained
Key exclusion criteria 1)The subjects who changed their prophylaxis within the previous 3 months
2)The subjects who received BOTOX or a nerve block within the previous 3 months
3)The subjects with any secondary headache except for MOH
4)The subjects who have severe neurologic and/or psychiatric disorders
5)The subjects who have epilepsy
6)Pregnant or breast-feeding women
7)The subjects who have severe heart, liver, and/or renal dysfunction
8)The subjects who are using opioids
9)The subjects who have allodynia
10)The subjects who have metal and/or electrical device in their body
11)The subjects who are using cardiac pace-maker and/or implantable cardioverter-defibrillator
12)The subjects whom investigators estimate are not eligible
Target sample size 100

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Takao TAKESHIMA
Organization Tominaga Hospital
Division name Headache center Department of Neurology
Zip code
Address 556-0017 4-48, Minatomachi 1-chome, Naniwa-ku Osaka-city, Osaka, Japan
TEL 81-6-6568-1601
Email Takao.Takeshima@nifty.com

Public contact
1st name of contact person
1st name
Middle name
Last name Daisuke DANNO
Organization Tominaga Hospital
Division name Headache center Department of Neurology
Zip code
Address 556-0017 4-48, Minatomachi 1-chome, Naniwa-ku Osaka-city, Osaka, Japan
TEL 81-6-6568-1601
Homepage URL
Email daisukedanno@yahoo.co.jp

Sponsor
Institute Tominaga Hospital
Institute
Department

Funding Source
Organization Not applicable
Organization
Division
Category of Funding Organization Self funding
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
2018 Year 07 Month 10 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2016 Year 02 Month 08 Day
Date of IRB
Anticipated trial start date
2016 Year 04 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
2018 Year 07 Month 09 Day
Last modified on
2018 Year 07 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038001

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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