Multi-center, Double-blind, Randomized, Sham-controlled Trial on the Acute Treatment of Migraine With the Cefaly® Device
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cefaly Technology
- Enrollment
- 106
- Locations
- 5
- Primary Endpoint
- Pain Score 1-hour
Study Overview
Brief Summary
The main objective of this study is to assess the efficacy of the Cefaly® device as an acute treatment of migraine attack in adult patients. The patients will be applied either an active or placebo external neurostimulation for 1 hour during a migraine attack, and will report the pain on a visual analog scale before and after the treatment.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •History of episodic or chronic migraine with or without aura meeting the diagnostic criteria listed in ICHD-III beta (2013) section 1, migraine, with the exception of ''complicated migraine'' (i.e., hemiplegic migraine, basilar-type migraine, ophthalmoplegic migraine, migrainous infarction)
- •Having a migraine attack lasting at least 3 hours
- •Migraine pain intensity stabilized for at least 1 hour
- •Frontal, retro-, or peri- orbital headache.
Exclusion Criteria
- •Pregnant women
- •Patients having received Botox treatment in the prior 4 months
- •Patients having received supraorbital nerve blocks in the prior 4 months
- •Diagnosis of other primary or secondary headache disorders, except of Medication Overuse Headache
- •Patients with only temporal or occipital headache
- •Patients using opioid medication
- •Patients having taken abortive migraine medication in the prior 3 hours
- •Allodynia: intolerance to supraorbital neurostimulation (allodynia) that makes the treatment not applicable (the patients will be excluded if they are unable to tolerate the first 5 minutes of neurostimulation).
- •Implanted metal or electrical devices in the head
- •Cardiac pacemaker or implanted or wearable defibrillator
- •Patient having had a previous experience with Cefaly®
Arms & Interventions
Active device
60 minutes of active external trigeminal nerve stimulation with a CEFALY Active device
Intervention: CEFALY Active (Device)
Sham device
60 minutes of placebo external trigeminal nerve stimulation with a CEFALY Placebo device
Intervention: CEFALY Placebo (Device)
Outcomes
Primary Outcomes
Pain Score 1-hour
Time Frame: 1 hour
Mean change of pain score (measured on a pain visual analog scale containing 11 values, from 0 to 10, with 0 meaning no pain and 10 meaning maximal pain) at 1 hour compared to baseline
Secondary Outcomes
- Rescue Medication 2 Hours(2 hours)
- Pain Score 2 Hours(2 hours)
- Rescue Medication 24 Hours(24 hours)
- Pain Score 24 Hours(24 hours)