Transcranial Magnetic Stimulation in Episodic Migraine (Magnet-EM)

Universiti Putra Malaysia76 enrolled

Overview

This study will assess the safety and efficacy of repetitive transcranial magnetic stimulation (rTMS) as new preventive treatment of migraine.

Migraine patients according to International Headache Society criteria will be allocated randomly into two treatment arms. One group will receive active rTMS and another group will receive sham rTMS for treatment phase (5 sessions). Assessment will be made at baseline, month 1, month 2 and month 3 post-treatment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Migraine

Interventions

Repetitive Transcranial Magnetic Stimulation.DEVICE

High frequency rTMS on left dorsolateral prefrontal cortex.

Sham rTMSDEVICE

Sham rTMS without active magnetic coil on left dorsolateral prefrontal cortex.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion criteria: 1. Males or females aged 18 to 60 years of age. 2. Subjects fulfilling criteria for episodic migraine as per the Third Edition of The International Headache Society (ICHD-3) for at least 1 year. 3. Frequency of migraine attacks 2-8 times per month with less than 15 headache days per month for at least 3 months prior to screening. 4. Demonstrated compliance with the headache diary during the run-in period by entry of headache data on a minimum of 24/30 days (80% compliance). 5. A signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study including any known and potential risks and available alternative treatments. Exclusion criteria: 1. Patients with previous history of rTMS treatment. 2. Onset of headache at more than 50-year-old. 3. Headache with red flags symptoms that may suggest organic secondary headaches. 4. Pregnant or lactating women. 5. Patients with contraindications to TMS such as metallic implant and pacemaker based on the Screening 13-item Questionnaire for rTMS candidate. 6. Patients with medical conditions such severe hypertension, infections, malignancy, cardiovascular and cerebrovascular disease, epilepsy degenerative central nervous system diseases, renal failure, hepatic failure, bleeding diathesis and serious mental illness.

Locations (1)

University Putra Malaysia

Serdang, Selangor, Malaysia

Outcomes

Primary Outcomes

Change from baseline in mean monthly migraine days.

The mean monthly migraine days will be calculated using the monthly migraine days from each of the month of the double-blind treatment phase.

Time frame: Baseline and month 1, 2 and 3 post treatment

Secondary Outcomes

Change from baseline in mean monthly migraine attacks.

The mean monthly migraine attacks will be calculated using the monthly migraine attack from each of the month of the double-blind treatment phase.

Time frame: Baseline and month 1, 2 and 3 post treatment

Proportion of subjects with at least a 50% reduction from baseline in mean monthly migraine days.

Change from baseline in mean monthly pain intensity of migraine attacks. The mean monthly pain intensity will be based on the record of the maximal pain intensity by means of a verbal scale (i.e. 0 =no headache; 1 = mild headache; 2 = moderate headache; 3 = severe headache) prior to taking symptomatic medication.

Time frame: Baseline and month 1, 2 and 3 post treatment

Frequency and severity of adverse events in response to rTMS.

Recorded any adverse events as per Good Clinical Practice Guideline and Declaration of Helsinki.

Time frame: During treatment and up until 1 month post treatment

The Depression Anxiety Stress Scale (DASS 21) score changes in migraine patients in response to rTMS.

Mean score changes from baseline for depression, anxiety and stress category.

Time frame: Baseline and at month 3 post treatment

The Migraine Disability Assessment Test (MIDAS) score changes in migraine patients in response to rTMS.

Mean score changes from baseline.

Data from ClinicalTrials.gov

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