Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
140 participants
INTERVENTIONAL
2020-12-04
2023-01-10
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Intervention
Millimetric wave emission bracelet.
Wristband with millimeter wave emission.
Wristband treatment with millimeter wave emission twice a day for 3 months.
Control
Placebo bracelet.
Placebo of wristband with millimeter wave emission.
Treatment with a millimeter wave emission wristband placebo twice a day for 3 months.
Interventions
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Wristband with millimeter wave emission.
Wristband treatment with millimeter wave emission twice a day for 3 months.
Placebo of wristband with millimeter wave emission.
Treatment with a millimeter wave emission wristband placebo twice a day for 3 months.
Eligibility Criteria
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Inclusion 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 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
18 Years
ALL
No
Sponsors
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Remedee SA
INDUSTRY
Responsible Party
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Principal Investigators
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Caroline MD MAINDET
Role: PRINCIPAL_INVESTIGATOR
CHUGA, 38000 Grenoble
Locations
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CHU Grenoble Alpes
Grenoble, , France
Cabinet Mornant
Mornant, , France
CH Fondation Rotschild
Paris, , France
Cabinet Saint Ismier
Saint-Ismier, , France
Cabinet Neuralpes
Saint-Martin-d'Hères, , France
CH Voiron
Voiron, , France
Countries
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Other Identifiers
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MISTIC
Identifier Type: -
Identifier Source: org_study_id
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