Transcranial Magnetic Stimulation in Episodic Migraine (Magnet-EM)

Migraine Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03556722
• Other study ID #: GPB/2017/9585500
• Status: Completed
• Phase: N/A
• Start date: April 15, 2019
• Est. completion date: April 1, 2022

Study information

• Verified date: October 2022
• Source: Universiti Putra Malaysia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: April 1, 2022
• Est. primary completion date: February 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Device:
• Repetitive Transcranial Magnetic Stimulation.
High frequency rTMS on left dorsolateral prefrontal cortex.
• Sham rTMS
Sham rTMS without active magnetic coil on left dorsolateral prefrontal cortex.

Locations

Country	Name	City	State
Malaysia	University Putra Malaysia	Serdang	Selangor

Sponsors (1)

Lead Sponsor	Collaborator
Universiti Putra Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and month 1, 2 and 3 post treatment
Secondary	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.	Baseline and month 1, 2 and 3 post treatment
Secondary	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.	Baseline and month 1, 2 and 3 post treatment
Secondary	Frequency and severity of adverse events in response to rTMS.	Recorded any adverse events as per Good Clinical Practice Guideline and Declaration of Helsinki.	During treatment and up until 1 month post treatment
Secondary	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.	Baseline and at month 3 post treatment
Secondary	The Migraine Disability Assessment Test (MIDAS) score changes in migraine patients in response to rTMS.	Mean score changes from baseline.	Baseline and at month 3 post treatment
Secondary	The Migraine Specific Questionnaire (MSQ) version 2.1 score changes in migraine patients in response to r-TMS.	Mean score changes from baseline.	Baseline and at month 3 post treatment
Secondary	The EQ-5D score changes in migraine patients in response to rTMS.	Mean score changes from baseline.	Baseline and at month 3 post treatment
Secondary	The Pittsburgh Sleep Quality Index score changes in migraine in response to rTMS.	Mean score changes from baseline for sleep quality.	Baseline and at month 3 post treatment
Secondary	The Food Frequency Questionnaire score in migraine patients	Measuring food frequency intake at baseline	Baseline
Secondary	The Global Physical Activity Questionnaire score change in migraine in response to rTMS.	Mean score changes from baseline.	Baseline and at month 3 post treatment
Secondary	Transcranial Doppler (TCD) pattern changes in migraine patients in response to rTMS.	Mean flow velocity (cm/s).	Baseline and at month 3 post treatment
Secondary	Electroencephalography (EEG) pattern change in migraine patients in response to rTMS.	EEG pattern differences based on report.	Baseline and at month 3 post treatment
Secondary	Serum serotonin level in migraine patients in response to rTMS.	Serum serotonin (ng/ml).	Baseline and at month 3 post treatment
Secondary	Serum beta-endorphin level changes in migraine patients in response to rTMS.	Serum beta endorphin (ng/ml).	Baseline and at month 3 post treatment
Secondary	Serum Calcitonin gene related peptide (CGRP) level in migraine patients in response to rTMS.	Serum CGRP (pg/ml).	Baseline and at month 3 post treatment
Secondary	Satisfaction measures of efficacy, tolerability, safety and expectations of rTMS among the participants.	A 5-point, Likert scale will be used to evaluate satisfaction with rTMS in migraine prevention.	At month 3 post treatment