The Role of Left Prefrontal Transcranial Magnetic Stimulation in Episodic Migraine Prophylaxis

Study Overview
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Brief Summary
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The aim of the study was to examine the prophylactic role of repetitive transcranial magnetic stimulation (rTMS) on the frequency, and severity of migraine attacks in episodic migraineurs who failed medical treatment. A group received 5 rTMS sessions, delivered over one week. Each rTMS session consisted of a single train of 900 total pulses over 3 minutes duration given at 5-Hz frequency and 100% motor threshold intensity and the placebo group received rTMS with the same stimulation frequency at a fixed intensity of 50% of the machine output

Official Title
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The Role of Left Prefrontal Transcranial Magnetic Stimulation in Episodic Migraine Prophylaxis

Conditions
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Episodic Migraine, Prophylaxis

Intervention / Treatment
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* Device: repetitive transcranial magnetic stimulation (rTMS) 100% motor threshold
* Device: repetitive transcranial magnetic stimulation (rTMS) 50% motor threshold


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: cases diagnosed as episodic migraine with or without aura according to the ICHD 3rd edition With a headache frequency of 4-14 per month for the last six months Patients who had either an unsatisfactory response, declined or were intolerant to at least two prophylactic medications. Exclusion Criteria: Patients with past family history of seizures Other chronic pain disorders Severe depression (Beck Depression Inventory of 30 or more) Other significant neurologic or psychiatric diagnosis including substance misuse Metal implants in the head Pregnant or breastfeeding ladies Prior experience with TMS

Ages Eligible for Study
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Minimum Age: 16 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Receiving repetitive transcranial magnetic stimulation (rTMS)<br>This group received 5 rTMS sessions, delivered over one week over the left dorsolateral prefrontal cortex (LDLPFC ) at 5-Hz frequency and 100% motor threshold intensity. | Device: repetitive transcranial magnetic stimulation (rTMS) 100% motor threshold<br>* Each rTMS session consisted of a single train of 900 total pulses over 3 minutes duration.<br>|
| Placebo Comparator: Group receiving placebo rTMS<br>This group received Placebo rTMS was given with the same stimulation frequency at a fixed intensity of 50% of the machine output | Device: repetitive transcranial magnetic stimulation (rTMS) 50% motor threshold<br>* Each rTMS session consisted of a single train of 900 total pulses over 3 minutes duration.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Migraine attack frequency | The primary outcome measure was defined as the reduction of number of migraine attacks by at least 50% after rTMS sessions. | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Migraine days | Number of days that the migraine attack lasts in | 2 months | 
| Migraine attack severity | The intensity of pain that was assessed using the zero to ten Numeric Pain Rating Scale (NPRS) | 2 months | 
| Functional disability | Functional disability was measured using the HIT-6 score. Severe HIT-6 was defined as a score of 60 or more. A clinically significant change in the HIT-6 was defined as a change of five points or more. | 2 months | 
| Use of abortive pills | Number of pills used per month | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rTMS = repetitive transcranial magnetic stimulation, LDLPFC = Left dorsolateral prefrontal cortex, HIT 6 = Headache Impact test, NPRS = Numeric Pain Rating Scale, ICHD = The international classfication of Headache disorder, MT= Motor threshold