UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The prospective study of the preventive effect of supraorbital transcutaneous stimulation using the Cefaly(R) device against frequent episodic migraine and chronic migraine
Title of the study (Brief title)	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
Name of lead principal investigator	Takao TAKESHIMA
Organization	Tominaga Hospital
Division name	Headache center Department of Neurology
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
Name of contact person	Daisuke DANNO
Organization	Tominaga Hospital
Division name	Headache center Department of Neurology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 02 Month 08 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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