Wristband with millimeter wave emission.
DeviceWristband treatment with millimeter wave emission twice a day for 3 months.
NCT Number: NCT04568252
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
CHU Grenoble Alpes, Grenoble, France
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 :
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 3 months.
Sequential hierarchical analysis on two criteria :
Time frame: 3 months.
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.
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.
Duration (in minutes) of patient-reported migraine crisis at 3 months from baseline (M0).
Time frame: 3 months.
Number of migraine crisis treatments.
Time frame: 3 months.
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.
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.
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.
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.
Comparison of the costs of consultations induced by migraine (hospitalizations, medical consultations).
Time frame: 3 months.
Comparison of the number of complementary alternative consultations at 3 months between the 2 groups.
Time frame: 6 months.
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.
Description of adverse events from M0 to M6 (number and type)
Time frame: 6 months.
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: 3 months.
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: 6 months.
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.
Remedee SA
Industry
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
Acronym: MISTIC
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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