Migraine STImulation Crisis of Migraine
MISTIC
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
1 other identifier
interventional
140
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2020
Typical duration for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 31, 2020
CompletedFirst Posted
Study publicly available on registry
September 29, 2020
CompletedStudy Start
First participant enrolled
December 4, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 10, 2023
CompletedMarch 6, 2023
March 1, 2023
1.9 years
July 31, 2020
March 3, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Sequential hierarchical analysis on two criteria : * the difference in the number of days with migraine in the month prior to M3, taking into account the number of days with migraine in the month prior to inclusion, using an ANCOVA (comparison of average between the 2 groups adjusted to the initial value according to the recommendations of Vickers and Altman). * the difference in the proportion of success at M3 (reduction in the number of days with migraine by more than 50% between inclusion and M3), evaluated by the Chi2 test.
3 months.
Secondary Outcomes (15)
To compare the evolution of migraine in terms of monthly monitoring.
3 months.
To evaluate the effects of wearing a millimeter wave wristband on the severity of migraine crisis.
3 months.
To evaluate the effects of wearing a millimeter wave wristband on the duration of migraine crisis.
3 months.
Evaluation of the consumption of migraine crisis treatments between the 2 groups.
3 months.
To evaluate the effects of wearing the MMW wristband on the specific (i.e. migraine-related) quality of life of migraine patients (functional disability).
3 months.
- +10 more secondary outcomes
Study Arms (2)
Intervention
EXPERIMENTALMillimetric wave emission bracelet.
Control
SHAM COMPARATORPlacebo bracelet.
Interventions
Wristband treatment with millimeter wave emission twice a day for 3 months.
Treatment with a millimeter wave emission wristband placebo twice a day for 3 months.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Remedee SAlead
Study Sites (6)
CHU Grenoble Alpes
Grenoble, 38000, France
Cabinet Mornant
Mornant, 69440, France
CH Fondation Rotschild
Paris, 75019, France
Cabinet Saint Ismier
Saint-Ismier, 38330, France
Cabinet Neuralpes
Saint-Martin-d'Hères, 38400, France
CH Voiron
Voiron, 38500, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Caroline MD MAINDET
CHUGA, 38000 Grenoble
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2020
First Posted
September 29, 2020
Study Start
December 4, 2020
Primary Completion
October 15, 2022
Study Completion
January 10, 2023
Last Updated
March 6, 2023
Record last verified: 2023-03