Migraine STImulation Crisis of Migraine (MISTIC)

Remedee Labs

Status

Completed

Conditions

Migraine Without Aura

Treatments

Device: Wristband with millimeter wave emission.

Device: Placebo of wristband with millimeter wave emission.

Study type

Interventional

Funder types

Industry

Identifiers

NCT04568252

MISTIC

Details and patient eligibility

About

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.

Full 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.

Enrollment

140 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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