Migraine with and without aura, including chronic migraine (ICHD-3beta 1.1, 1.2.1, or 1.3)
Conditions
Interventions
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.
Sponsors
Tominaga Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The decrease of migraine days after 12 weeks of treatment from run-in phase | — |
Countries
Japan
Contacts
Public ContactDaisuke DANNO
Tominaga Hospital Headache center Department of Neurology
Outcome results
None listed