Migraine Without AuraMISTICNCT04568252
Migraine STImulation Crisis of Migraine
A study testing Wristband with millimeter wave emission. in people with Migraine Without Aura, run by Remedee SA at 6 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine Without Aura
- What is being tested?
- Wristband with millimeter wave emission.
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 6 sitesFrance
- Study dates
- 4 Dec 2020to 10 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 11Show fewer
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
CHU Grenoble Alpes
Grenoble, 38000
Cabinet Mornant
Mornant, 69440
CH Fondation Rotschild
Paris, 75019
Cabinet Saint Ismier
Saint-Ismier, 38330
Cabinet Neuralpes
Saint-Martin-d'Hères, 38400
CH Voiron
Voiron, 38500
About this study
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
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.
Read the 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
- Migraine Without Aura
- Being tested
- Wristband with millimeter wave emission., Placebo of wristband with millimeter wave emission.
- Keywords
- Migraine, Prophylaxis, Millimeter waves, Pain, Neuromodulation
- Medical subject headings
- Migraine without Aura, Migraine Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wristband with millimeter wave emission.Device
Wristband treatment with millimeter wave emission twice a day for 3 months.
Placebo of wristband with millimeter wave emission.Device
Treatment with a millimeter wave emission wristband placebo twice a day for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Millimetric wave emission bracelet. Receives: Device: Wristband with millimeter wave emission. |
| Control | Sham comparator | Placebo bracelet. Receives: Device: Placebo of wristband with millimeter wave emission. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months.
Secondary outcomes (15)
To compare the evolution of migraine in terms of monthly monitoring.
Comparison of the evolution's kinetic of the number of days with migraine between the baseline (M0) and 3 months using monthly data (M1-M2-M3).
Measured: 3 months.
To evaluate the effects of wearing a millimeter wave wristband on the severity of migraine crisis.
Headache Impact Test (named HIT-6 questionnaire) Self-Rating Scale (3 levels : mild, moderate, severe).
The HIT-6 questionnaire contains 6 questions (3 first questions assessing the impact of the crisis and 3 last questions assessing the impact of the crisis).
The minimum score is 36 and the maximum score is 78. It can result in a categorical use to define four grades of increasing severity: score ≤ 49: low impact; score 50-50: definite impact; score 56-59: significant impact; score ≥ 60: impact major. The higher the score, the greater the impact of headaches on quality of life.
Measured: 3 months.
To evaluate the effects of wearing a millimeter wave wristband on the duration of migraine crisis.
Duration (in minutes) of patient-reported migraine crisis at 3 months from baseline (M0).
Measured: 3 months.
Evaluation of the consumption of migraine crisis treatments between the 2 groups.
Number of migraine crisis treatments.
Measured: 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).
Evolution of the MIDAS questionnaire score between 0 and M3. The MIDAS questionnaire contains 5 questions.
Description of score : the higher the number of days, the higher severity :
0 to 5 days : no severity 6 to 10 days : little severity 11 to 20 days : moderate severity more 20 days : high severity
Measured: 3 months.
To evaluate the effects of wearing the MMW wristband on generic quality of life.
Evolution of the EQ5D-5L questionnaire score between 0 and M3. EQ-5D-5L is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of lige that can be used in a wide range of health conditions and treatments. The EQ5D has 6 items intended to measure general health. The top 5 rate mobility, independence, daily activities, pain / discomfort, and anxiety / depression, and are rated according to 5 values : "No problem", "little problem", "moderate problem", "high problem" and "Incapacity". This results in an index score. The last item deals with perceived health on the day the questionnaire is filled in and uses a visual analogue scale from 0 (wors) to 100 (best health possible) (Visual Analog Scale Score)
Measured: 3 months.
To evaluate the effects of wearing a millimeter wave wristband on associated anxiety and depressive disorders.
Evolution of the HADS questionnaire between 0 and M3. The HADS questionnaire contains 14 questions. The minimum score is 0 and the maximum score is 42.
The higher the score, the depression is important :
score < 7 : no depression score 8 to 10 : doubtful depression score > 11 : proven depression
Measured: 3 months.
To evaluate the effects of wearing a millimeter wave wristband on the quality of sleep.
Evolution of the MOS-Sleep questionnaire between 0 and M3. The PSQI questionnaire contains 12 questions. The minimum score is 0 and the maximum score is 100 : a score of 0 corresponds to a bad quality of spleep and a score of 100 to a good quality of spleep (no difficulties).
Measured: 3 months.
To evaluate the consumption in consultations (any type of care use) for migraine between the 2 groups.
Comparison of the costs of consultations induced by migraine (hospitalizations, medical consultations).
Measured: 3 months.
To assess the consumption of complementary alternative migraine care between the 2 groups.
Comparison of the number of complementary alternative consultations at 3 months between the 2 groups.
Measured: 3 months.
To evaluate the stability of the effect of wearing the MMW wristband over the long term in the intervention group.
Evaluation of the maintenance of the stability of the effect of wearing the MMW at the long term (6 months) on the number of the migraine day for the principal outcome.
Measured: 6 months.
Adverse events.
Description of adverse events from M0 to M6 (number and type)
Measured: 6 months.
To assess patient satisfaction with participation in the study.
Questionnaire of satisfaction with the choice of treatment at 6 months. This questionnaire of satisfaction was created by our team in order to evaluate the satifaction of patient included in this study.
It contains 13 questions. No score will be calculated, only description of answers.
Measured: 6 months.
Observance of the use of MMW wristband.
Analysis of the recorded data related to the MMW wristband. The validation of the recordings is defined by the presence of at least 2/3 of the data during the total time of use of the bracelet during 3 months.
Measured: 3 months.
Subgroup analysis of the number of migraine day for the principal outcome in relation to patients with or without prior prophylactic treatment.
To analyse if there is a best adaptation of treatment with ou without prior prophylactic treatment (stratification on the prior prophylactic treatment variable) on the number of migraine day for the principal outocme.
Measured: 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2020
- Study start4 Dec 2020
- Primary completion15 Oct 2022
- Study completion10 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine Without AuraStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization : intervention group and control group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Remedee SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Caroline MD MAINDET, Principal investigator, CHUGA, 38000 Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04568252
- Sponsor's protocol ID
- MISTIC
- Acronym
- MISTIC
- Status last verified
- Mar 2023
- First submitted
- 31 Jul 2020
- Last updated
- 6 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04568252
- Acronym / sponsor ID
- MISTIC / MISTIC
- Conditions
- Migraine Without Aura
- Keywords
- Migraine, Prophylaxis, Millimeter waves, Pain, Neuromodulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Remedee SAIndustry (pharma, biotech, devices)
- Study start
- 4 Dec 2020 (actual)
- Primary completion
- 15 Oct 2022 (actual)
- Study completion
- 10 Jan 2023 (actual)
- First posted
- 29 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomization : intervention group and control group
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Wristband with millimeter wave emission.Millimetric wave emission bracelet. |
| Control | Sham comparator | Device: Placebo of wristband with millimeter wave emission.Placebo bracelet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wristband with millimeter wave emission.Wristband treatment with millimeter wave emission twice a day for 3 months. | Device | Intervention |
| Placebo of wristband with millimeter wave emission.Treatment with a millimeter wave emission wristband placebo twice a day for 3 months. | Device | Control |
Primary outcome
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.
Time frame: 3 months.
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.
15 secondary outcomes
To compare the evolution of migraine in terms of monthly monitoring.
Time frame: 3 months.
To evaluate the effects of wearing a millimeter wave wristband on the severity of migraine crisis.
Time frame: 3 months.
To evaluate the effects of wearing a millimeter wave wristband on the duration of migraine crisis.
Time frame: 3 months.
Evaluation of the consumption of migraine crisis treatments between the 2 groups.
Time frame: 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).
Time frame: 3 months.
To evaluate the effects of wearing the MMW wristband on generic quality of life.
Time frame: 3 months.
To evaluate the effects of wearing a millimeter wave wristband on associated anxiety and depressive disorders.
Time frame: 3 months.
To evaluate the effects of wearing a millimeter wave wristband on the quality of sleep.
Time frame: 3 months.
To evaluate the consumption in consultations (any type of care use) for migraine between the 2 groups.
Time frame: 3 months.
To assess the consumption of complementary alternative migraine care between the 2 groups.
Time frame: 3 months.
To evaluate the stability of the effect of wearing the MMW wristband over the long term in the intervention group.
Time frame: 6 months.
Adverse events.
Time frame: 6 months.
To assess patient satisfaction with participation in the study.
Time frame: 6 months.
Observance of the use of MMW wristband.
Time frame: 3 months.
Subgroup analysis of the number of migraine day for the principal outcome in relation to patients with or without prior prophylactic treatment.
Time frame: 6 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caroline MD MAINDET principal investigator
CHUGA, 38000 Grenoble
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wristband with millimeter wave emission. in people with Migraine Without Aura, run by Remedee SA at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 3 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2023.