Unique ID issued by UMIN | UMIN000033333 |
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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 |
The prospective study of the preventive effect of supraorbital transcutaneous stimulation using the Cefaly(R) device against frequent episodic migraine and chronic migraine
The prospective study of the preventive effect of supraorbital transcutaneous stimulation using the Cefaly(R) device against frequent episodic migraine and chronic migraine
The prospective study of the preventive effect of supraorbital transcutaneous stimulation using the Cefaly(R) device against frequent episodic migraine and chronic migraine
The prospective study of the preventive effect of supraorbital transcutaneous stimulation using the Cefaly(R) device against frequent episodic migraine and chronic migraine
Japan |
Migraine with and without aura, including chronic migraine (ICHD-3beta 1.1, 1.2.1, or 1.3)
Neurology |
Others
NO
To assess the preventive effect of supraorbital transcutaneous stimulation using the Cefaly(R) device against frequent episodic migraine and chronic migraine in Japan.
Safety,Efficacy
The decrease of migraine days after 12 weeks of treatment from run-in phase
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Device,equipment |
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.
18 | years-old | <= |
75 | years-old | >= |
Male and Female
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
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
100
1st name | |
Middle name | |
Last name | Takao TAKESHIMA |
Tominaga Hospital
Headache center Department of Neurology
556-0017 4-48, Minatomachi 1-chome, Naniwa-ku Osaka-city, Osaka, Japan
81-6-6568-1601
Takao.Takeshima@nifty.com
1st name | |
Middle name | |
Last name | Daisuke DANNO |
Tominaga Hospital
Headache center Department of Neurology
556-0017 4-48, Minatomachi 1-chome, Naniwa-ku Osaka-city, Osaka, Japan
81-6-6568-1601
daisukedanno@yahoo.co.jp
Tominaga Hospital
Not applicable
Self funding
NO
2018 | Year | 07 | Month | 10 | Day |
Partially published
Completed
2016 | Year | 02 | Month | 08 | Day |
2016 | Year | 04 | Month | 07 | Day |
2018 | Year | 07 | Month | 09 | Day |
2018 | Year | 07 | Month | 09 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038001
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