RCT Versus Placebo of rTMSQP Over Visual Cortex for the Prevention of Chronic Migraine

Study Overview
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Brief Summary
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Evaluation of inhibiting rTMS QP over the visual cortex for the prevention of chronic migraine. The aim of the study is to confirm that inhibiting rTMS QP is capable to decrease the frequency of migraine and if its effect is stronger than placebo effect.

Detailed Description
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The investigators have already inquired if inhibiting rTMS QP over the visual cortex determines a reduction of frequency of migraine in a previous study. After 2 weekly sessions for a month, the investigators demonstrated a reduction of 47% in migraine frequency. In this study, the investigators aim to compare rTMS QP effect with the placebo effect and to evaluate if rTMS QP is capable to induce changes in VEP, CHEPS and QST.

Official Title
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Randomised Placebo Controlled Trial of rTMS Quadri Pulse Over Visual Cortex for the Prevention of Chronic Migraine

Conditions
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Chronic Migraine

Intervention / Treatment
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* Device: Super Rapid Magstim Stimulator
* Device: Super Rapid Magstim Stimulator (sham)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of chronic migraine (ICHD III beta 1.3) with or without medication overuse. Exclusion Criteria: other diseases or contraindication for the magnetic stimulation (epilepsy, pacemaker, metallic prothesis)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Super Rapid Magstim Stimulator rTMS QP<br>rTMS QP is delivered over the visual cortex for 30 minutes, 2 times a week for 8 weeks, in 15 patients | Device: Super Rapid Magstim Stimulator<br>* The repetitive transcranial magnetic stimulation (rTMS) is able to modify cortical excitability and reactivity. 1Hz rTMS inhibits the cortex, 10Hz excites it. In particular, a new paradigm of rTMS, the rTMS quadri pulse has a more lasting and effective activity. The side effects are rare and transient: migraine,contractions of the muscles of the neck due to muscle stimulation by the electromagnetic field of the coil.<br>|
| Placebo Comparator: Placebo<br>rTMS QP placebo (coil perpendicular to the scalp) is delivered over the visual cortex for 30 minutes, 2 times a week for 8 weeks, in 15 patients. | Device: Super Rapid Magstim Stimulator (sham)<br>* coil perpendicular to the scalp<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of migraine | The investigators evaluate the frequency of migraine during the treatment and 2 months after its end. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensity of migraine | The investigators evaluate the intensity of migraine during the treatment and 2 months after its end | 12 months | 
| Acute medication intake | The investigators evaluate acute medication intake during the treatment and 2 months after its end | 12 months | 
| Attack duration | The investigators evaluate attack duration during the treatment and 2 months after its end | 12 months | 
| Scores on psychological scales | The investigators evaluate scores on psychological scales during the treatment and 2 months after its end | 12 months |