Clinical trial NCT03556722: Transcranial Magnetic Stimulation in Episodic Migraine (Magnet-EM)
Official title: Effectiveness and Tolerability of Repetitive Transcranial Magnetic Stimulation For Preventive Treatment Of Episodic Migraine: A Single Centre, Randomised, Double-Blind, Sham-Controlled Phase 2 Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Keywords: Repetitive Transcranial Magnetic Stimulation
Transcranial Doppler
Neuromodulation
Randomized Controlled Trials
Pain
Migraine prophylaxis
Dorsolateral Prefrontal Cortex
Protocol
Lead sponsor: Universiti Putra Malaysia
Sponsor class: OTHER
First posted: 2018-06-14
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm parallel assignment involves two groups of participants. One group receives r-TMS, and the other group receives sham placebo r-TMS.
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in mean monthly migraine days.
timeFrame: Baseline and month 1, 2 and 3 post treatment
Secondary outcomes:
measure: Change from baseline in mean monthly migraine attacks.
timeFrame: Baseline and month 1, 2 and 3 post treatment
measure: Proportion of subjects with at least a 50% reduction from baseline in mean monthly migraine days.
timeFrame: Baseline and month 1, 2 and 3 post treatment
measure: Frequency and severity of adverse events in response to rTMS.
timeFrame: During treatment and up until 1 month post treatment
measure: The Depression Anxiety Stress Scale (DASS 21) score changes in migraine patients in response to rTMS.
timeFrame: Baseline and at month 3 post treatment
measure: The Migraine Disability Assessment Test (MIDAS) score changes in migraine patients in response to rTMS.
timeFrame: Baseline and at month 3 post treatment
measure: The Migraine Specific Questionnaire (MSQ) version 2.1 score changes in migraine patients in response to r-TMS.
timeFrame: Baseline and at month 3 post treatment
measure: The EQ-5D score changes in migraine patients in response to rTMS.
timeFrame: Baseline and at month 3 post treatment
measure: The Pittsburgh Sleep Quality Index score changes in migraine in response to rTMS.
timeFrame: Baseline and at month 3 post treatment
measure: The Food Frequency Questionnaire score in migraine patients
timeFrame: Baseline
measure: The Global Physical Activity Questionnaire score change in migraine in response to rTMS.
timeFrame: Baseline and at month 3 post treatment
measure: Transcranial Doppler (TCD) pattern changes in migraine patients in response to rTMS.
timeFrame: Baseline and at month 3 post treatment
measure: Electroencephalography (EEG) pattern change in migraine patients in response to rTMS.
timeFrame: Baseline and at month 3 post treatment
measure: Serum serotonin level in migraine patients in response to rTMS.
timeFrame: Baseline and at month 3 post treatment
measure: Serum beta-endorphin level changes in migraine patients in response to rTMS.
timeFrame: Baseline and at month 3 post treatment
measure: Serum Calcitonin gene related peptide (CGRP) level in migraine patients in response to rTMS.
timeFrame: Baseline and at month 3 post treatment
measure: Satisfaction measures of efficacy, tolerability, safety and expectations of rTMS among the participants.
timeFrame: At month 3 post treatment
Other outcomes:
Locations:
city: Serdang
country: Malaysia
facility: University Putra Malaysia
state: Selangor
Study officials:
affiliation: University Putra Malaysia
name: Hamidon B. Basri
role: STUDY_CHAIR
affiliation: Universiti Putra Malaysia
name: Wan Aliaa B. Wan Sulaiman, MRCP
role: STUDY_DIRECTOR
affiliation: Universiti Putra Malaysia
name: Wan Aliaa B. Wan Sulaiman, MRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mohamad Safiai NI, Amir NA, Basri H, Inche Mat LN, Hoo FK, Yusof Khan AHK, Loh WC, Chia PK, Ramachandran V, Mat Din H, Samsudin IN, Fernandez A, Mohamed MH, Ching SM, Hashim HZ, Wan Sulaiman WA. Effectiveness and tolerability of repetitive transcranial magnetic stimulation for preventive treatment of episodic migraine: a single-centre, randomised, double-blind, sham-controlled phase 2 trial (Magnet-EM). Trials. 2020 Nov 11;21(1):923. doi: 10.1186/s13063-020-04832-y.