Clinical trial NCT04568252: Migraine STImulation Crisis of Migraine
Official title: Evaluation of the Impact of Wearing a Millimetre Wave Bracelet for 3 Months on the Frequency in Number of Days of Migraines in Patients With Episodic Migraines Without Aura
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine Without Aura
Keywords: Migraine
Prophylaxis
Millimeter waves
Pain
Neuromodulation
Lead sponsor: Remedee SA
Sponsor class: INDUSTRY
First posted: 2020-09-29
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization : intervention group and control group
Primary purpose: TREATMENT

Brief summary: Migraine is a neurovascular disease whose prevalence is estimated at almost 20% of the adult population. Currently, there is no treatment for migraine.

Millimeter stimulation of the wrist subcutaneous receptors allows the release of endorphin in the brain.

MISTIC is a prospective, controlled, multicenter, double-blind, randomized study in which the research team are investigating whether millimeter stimulation of subcutaneous wrist receptors reduces the frequency of migraine crisis.

Detailed description: MISTIC is a multicenter, controlled, randomized, double-blind study. Eligible patients will have to report their migraine crisis in a diary during a one month pre-selection phase. Then, patients will be randomized into one of two treatment groups :

* active millimeter wave emission bracelet
* or placebo bracelet

Patients will have to use the medical device twice a day for 3 months. The investigators will follow them for an additional 3 months to assess the persistence of the effect.

Throughout the follow-up, patients will report their migraines crisis in a journal.

The primary outcome will be the impact of wearing a millimeter wave bracelet for 3 months, on the number of days with migraine headaches.

Eligibility criteria: Inclusion Criteria:

* Patient with episodic migraine without aura (according to ICDH3 classification criteria)
* Patient with at leat 4 migraine days per month and no more than 8 migraine days per months
* Background treatment (or not) stable for at least 1 month
* Drug management of migraine stable for at least one month
* Non-drug management of stable migraine at least 1 month prior to the study
* Patient affiliated to social security or beneficiary of such a scheme

Exclusion Criteria:

* Patients with chronic migraine (defined according to IHS criteria)
* Patients already included in an interventional clinical research protocol
* Patients with chronic headache due to drug abuse (according to IHS criteria)
* Patients with only migraine crisis with aura
* Wrist size \< 14.5 and \> 21 cm
* Situations of dermatological pathologies on pre-existing wrists (oozing dermatosis, hyper sweating, eg.) or unhealed lesions on both wrists.
* Presence of metallic object (bracelet, watch, piercing...) on both wrists.
* Presence of a tattoo on both wrists
* Allergic reactions on contact with silicone or metal
* Persons referred to in Articles L 1121-5 to L 1121-8 of the CSP (corresponds to all protected persons) pregnant women, parturient women, nursing mothers, persons deprived of their liberty by judicial or administrative decision, persons subject to a legal protection measure
* Women of childbearing age with a short-term pregnancy project

Primary outcomes:
measure: To evaluate the effects of millimeter waves applied to the wrist (MMW) on the number of days with migraine(s) at 3 months reported by the patient with episodic migraine(s) without aura.
timeFrame: 3 months.
Secondary outcomes:
measure: To compare the evolution of migraine in terms of monthly monitoring.
timeFrame: 3 months.
measure: To evaluate the effects of wearing a millimeter wave wristband on the severity of migraine crisis.
timeFrame: 3 months.
measure: To evaluate the effects of wearing a millimeter wave wristband on the duration of migraine crisis.
timeFrame: 3 months.
measure: Evaluation of the consumption of migraine crisis treatments between the 2 groups.
timeFrame: 3 months.
measure: To evaluate the effects of wearing the MMW wristband on the specific (i.e. migraine-related) quality of life of migraine patients (functional disability).
timeFrame: 3 months.
measure: To evaluate the effects of wearing the MMW wristband on generic quality of life.
timeFrame: 3 months.
measure: To evaluate the effects of wearing a millimeter wave wristband on associated anxiety and depressive disorders.
timeFrame: 3 months.
measure: To evaluate the effects of wearing a millimeter wave wristband on the quality of sleep.
timeFrame: 3 months.
measure: To evaluate the consumption in consultations (any type of care use) for migraine between the 2 groups.
timeFrame: 3 months.
measure: To assess the consumption of complementary alternative migraine care between the 2 groups.
timeFrame: 3 months.
measure: To evaluate the stability of the effect of wearing the MMW wristband over the long term in the intervention group.
timeFrame: 6 months.
measure: Adverse events.
timeFrame: 6 months.
measure: To assess patient satisfaction with participation in the study.
timeFrame: 6 months.
measure: Observance of the use of MMW wristband.
timeFrame: 3 months.
measure: Subgroup analysis of the number of migraine day for the principal outcome in relation to patients with or without prior prophylactic treatment.
timeFrame: 6 months.
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHU Grenoble Alpes
city: Mornant
country: France
facility: Cabinet Mornant
city: Paris
country: France
facility: CH Fondation Rotschild
city: Saint-Ismier
country: France
facility: Cabinet Saint Ismier
city: Saint-Martin-d'Hères
country: France
facility: Cabinet Neuralpes
city: Voiron
country: France
facility: CH Voiron
Study officials:
affiliation: CHUGA, 38000 Grenoble
name: Caroline MD MAINDET
role: PRINCIPAL_INVESTIGATOR
References: