UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033333
Receipt number 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 12:59:30

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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

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

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 or person

Institute

Tominaga Hospital

Institute

Department

Personal name



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

Value
https://center6.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