Back to resultsMigraine STImulation Crisis of Migraine (MISTIC)
Primary Purpose
Migraine Without Aura
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Wristband with millimeter wave emission.
Placebo of wristband with millimeter wave emission.
Sponsored by
About this trial
This is an interventional treatment trial for Migraine Without Aura focused on measuring Migraine, Prophylaxis, Millimeter waves, Pain, Neuromodulation
Eligibility Criteria
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
Sites / Locations
- CHU Grenoble Alpes
- Cabinet Mornant
- CH Fondation Rotschild
- Cabinet Saint Ismier
- Cabinet Neuralpes
- CH Voiron
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Intervention
Control
Arm Description
Millimetric wave emission bracelet.
Placebo bracelet.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
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.
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).
Evaluation of the consumption of migraine crisis treatments between the 2 groups.
Number of migraine crisis treatments.
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
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)
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
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).
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).
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.
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.
Adverse events.
Description of adverse events from M0 to M6 (number and type)
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04568252
Brief Title
Migraine STImulation Crisis of Migraine
Acronym
MISTIC
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
December 4, 2020 (Actual)
Primary Completion Date
October 15, 2022 (Actual)
Study Completion Date
January 10, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Remedee SA
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Without Aura
Keywords
Migraine, Prophylaxis, Millimeter waves, Pain, Neuromodulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomization : intervention group and control group
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Millimetric wave emission bracelet.
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Placebo bracelet.
Intervention Type
Device
Intervention Name(s)
Wristband with millimeter wave emission.
Intervention Description
Wristband treatment with millimeter wave emission twice a day for 3 months.
Intervention Type
Device
Intervention Name(s)
Placebo of wristband with millimeter wave emission.
Intervention Description
Treatment with a millimeter wave emission wristband placebo twice a day for 3 months.
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
3 months.
Secondary Outcome Measure Information:
Title
To compare the evolution of migraine in terms of monthly monitoring.
Description
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).
Time Frame
3 months.
Title
To evaluate the effects of wearing a millimeter wave wristband on the severity of migraine crisis.
Description
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.
Time Frame
3 months.
Title
To evaluate the effects of wearing a millimeter wave wristband on the duration of migraine crisis.
Description
Duration (in minutes) of patient-reported migraine crisis at 3 months from baseline (M0).
Time Frame
3 months.
Title
Evaluation of the consumption of migraine crisis treatments between the 2 groups.
Description
Number of migraine crisis treatments.
Time Frame
3 months.
Title
To evaluate the effects of wearing the MMW wristband on the specific (i.e. migraine-related) quality of life of migraine patients (functional disability).
Description
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
Time Frame
3 months.
Title
To evaluate the effects of wearing the MMW wristband on generic quality of life.
Description
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)
Time Frame
3 months.
Title
To evaluate the effects of wearing a millimeter wave wristband on associated anxiety and depressive disorders.
Description
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
Time Frame
3 months.
Title
To evaluate the effects of wearing a millimeter wave wristband on the quality of sleep.
Description
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).
Time Frame
3 months.
Title
To evaluate the consumption in consultations (any type of care use) for migraine between the 2 groups.
Description
Comparison of the costs of consultations induced by migraine (hospitalizations, medical consultations).
Time Frame
3 months.
Title
To assess the consumption of complementary alternative migraine care between the 2 groups.
Description
Comparison of the number of complementary alternative consultations at 3 months between the 2 groups.
Time Frame
3 months.
Title
To evaluate the stability of the effect of wearing the MMW wristband over the long term in the intervention group.
Description
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.
Time Frame
6 months.
Title
Adverse events.
Description
Description of adverse events from M0 to M6 (number and type)
Time Frame
6 months.
Title
To assess patient satisfaction with participation in the study.
Description
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.
Time Frame
6 months.
Title
Observance of the use of MMW wristband.
Description
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.
Time Frame
3 months.
Title
Subgroup analysis of the number of migraine day for the principal outcome in relation to patients with or without prior prophylactic treatment.
Description
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.
Time Frame
6 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caroline MD MAINDET
Organizational Affiliation
CHUGA, 38000 Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Grenoble Alpes
City
Grenoble
ZIP/Postal Code
38000
Country
France
Facility Name
Cabinet Mornant
City
Mornant
ZIP/Postal Code
69440
Country
France
Facility Name
CH Fondation Rotschild
City
Paris
ZIP/Postal Code
75019
Country
France
Facility Name
Cabinet Saint Ismier
City
Saint-Ismier
ZIP/Postal Code
38330
Country
France
Facility Name
Cabinet Neuralpes
City
Saint-Martin-d'Hères
ZIP/Postal Code
38400
Country
France
Facility Name
CH Voiron
City
Voiron
ZIP/Postal Code
38500
Country
France
12. IPD Sharing Statement
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Migraine STImulation Crisis of Migraine
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