Trials / Completed
CompletedNCT04568252
Migraine STImulation Crisis of Migraine
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 140 (actual)
- Sponsor
- Remedee SA · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Wristband with millimeter wave emission. | Wristband treatment with millimeter wave emission twice a day for 3 months. |
| DEVICE | Placebo of wristband with millimeter wave emission. | Treatment with a millimeter wave emission wristband placebo twice a day for 3 months. |
Timeline
- Start date
- 2020-12-04
- Primary completion
- 2022-10-15
- Completion
- 2023-01-10
- First posted
- 2020-09-29
- Last updated
- 2023-03-06
Locations
6 sites across 1 country: France
Source: ClinicalTrials.gov record NCT04568252. Inclusion in this directory is not an endorsement.