Migraine
Conditions
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.
Interventions
DEVICECEFALY Active
Active external trigeminal nerve stimulation
DEVICECEFALY Placebo
Placebo external trigeminal nerve stimulation
Sponsors
Cefaly Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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®
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score 1-hour | 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
| Measure | Time frame | Description |
|---|---|---|
| Rescue Medication 2 Hours | 2 hours | Number of patients not having required rescue medication at 2 hours |
| Pain Score 2 Hours | 2 hours | 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 2 hours compared to baseline (if rescue therapy was not used) |
| Rescue Medication 24 Hours | 24 hours | Number of patients not having required rescue medication within 24 hours |
| Pain Score 24 Hours | 24 hours | 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 24 hours compared to baseline (if rescue therapy was not used) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active Device 60 minutes of active external trigeminal nerve stimulation with a CEFALY device
CEFALY Active: Active external trigeminal nerve stimulation | 52 |
| Sham Device 60 minutes of placebo external trigeminal nerve stimulation with a CEFALY device
CEFALY Placebo: Placebo external trigeminal nerve stimulation | 54 |
| Total | 106 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Failed the nociceptive test | 2 | 1 |
| Overall Study | Withdrawal by Subject | 3 | 1 |
Baseline characteristics
| Characteristic | Active Device | Sham Device | Total |
|---|---|---|---|
| Age, Continuous | 39.71 years STANDARD_DEVIATION 13.62 | 40.09 years STANDARD_DEVIATION 12.65 | 39.90 years STANDARD_DEVIATION 13.14 |
| Migraine duration (hours) | 7 hours | 6 hours | 6 hours |
| Migraine type Migraine with aura | 12 Participants | 5 Participants | 17 Participants |
| Migraine type Migraine without aura | 40 Participants | 49 Participants | 89 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 43 Participants | 49 Participants | 92 Participants |
| Sex: Female, Male Male | 9 Participants | 5 Participants | 14 Participants |
| Use of acute medication before enrollment | 17 Participants | 14 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 52 | 0 / 54 |
| other Total, other adverse events | 1 / 52 | 0 / 54 |
| serious Total, serious adverse events | 0 / 52 | 0 / 54 |
Outcome results
Primary
Pain Score 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
Time frame: 1 hour
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Device | Pain Score 1-hour | -59 percent change | Standard Deviation 35 |
| Sham Device | Pain Score 1-hour | -30 percent change | Standard Deviation 31 |
p-value: <0.0001Wilcoxon (Mann-Whitney)
Primary
Pain Score 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
Time frame: 1 hour
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Device | Pain Score 1-hour | -3.46 units on a scale | Standard Deviation 2.32 |
| Sham Device | Pain Score 1-hour | -1.78 units on a scale | Standard Deviation 1.89 |
p-value: <0.0001Wilcoxon (Mann-Whitney)
Secondary
Pain Score 24 Hours
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 24 hours compared to baseline (if rescue therapy was not used)
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Device | Pain Score 24 Hours | -3.46 units on a scale | Standard Deviation 2.65 |
| Sham Device | Pain Score 24 Hours | -2.38 units on a scale | Standard Deviation 2.27 |
p-value: 0.062Wilcoxon (Mann-Whitney)
Secondary
Pain Score 24 Hours
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 24 hours compared to baseline (if rescue therapy was not used)
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Device | Pain Score 24 Hours | -57 percent change | Standard Deviation 37 |
| Sham Device | Pain Score 24 Hours | -40 percent change | Standard Deviation 40 |
p-value: 0.037Wilcoxon (Mann-Whitney)
Secondary
Pain Score 2 Hours
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 2 hours compared to baseline (if rescue therapy was not used)
Time frame: 2 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Device | Pain Score 2 Hours | -2.87 units on a scale | Standard Deviation 2.24 |
| Sham Device | Pain Score 2 Hours | -1.85 units on a scale | Standard Deviation 1.96 |
p-value: 0.028Wilcoxon (Mann-Whitney)
Secondary
Pain Score 2 Hours
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 2 hours compared to baseline (if rescue therapy was not used)
Time frame: 2 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Device | Pain Score 2 Hours | -50 percent change | Standard Deviation 36 |
| Sham Device | Pain Score 2 Hours | -32 percent change | Standard Deviation 37 |
p-value: 0.026Wilcoxon (Mann-Whitney)
Secondary
Rescue Medication 24 Hours
Number of patients not having required rescue medication within 24 hours
Time frame: 24 hours
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Active Device | Rescue Medication 24 Hours | Patients having used rescue medication within 24 h | 18 Participants |
| Active Device | Rescue Medication 24 Hours | Patients not having used rescue med within 24h | 27 Participants |
| Active Device | Rescue Medication 24 Hours | Patients for whom med data was not available | 7 Participants |
| Sham Device | Rescue Medication 24 Hours | Patients having used rescue medication within 24 h | 21 Participants |
| Sham Device | Rescue Medication 24 Hours | Patients not having used rescue med within 24h | 30 Participants |
| Sham Device | Rescue Medication 24 Hours | Patients for whom med data was not available | 3 Participants |
p-value: 1Wilcoxon (Mann-Whitney)
Secondary
Rescue Medication 2 Hours
Number of patients not having required rescue medication at 2 hours
Time frame: 2 hours
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Active Device | Rescue Medication 2 Hours | Patients having used rescue medication at 2 hours | 3 Participants |
| Active Device | Rescue Medication 2 Hours | Patients not having used rescue medication at 2 h | 44 Participants |
| Active Device | Rescue Medication 2 Hours | Patients for whom med data was not available | 5 Participants |
| Sham Device | Rescue Medication 2 Hours | Patients for whom med data was not available | 2 Participants |
| Sham Device | Rescue Medication 2 Hours | Patients having used rescue medication at 2 hours | 2 Participants |
| Sham Device | Rescue Medication 2 Hours | Patients not having used rescue medication at 2 h | 50 Participants |
p-value: 0.666Fisher Exact