Migraine
Conditions
Keywords
Repetitive Transcranial Magnetic Stimulation, Transcranial Doppler, Neuromodulation, Randomized Controlled Trials, Pain, Migraine prophylaxis, Dorsolateral Prefrontal Cortex, Protocol
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.
Interventions
DEVICERepetitive Transcranial Magnetic Stimulation.
High frequency rTMS on left dorsolateral prefrontal cortex.
DEVICESham rTMS
Sham rTMS without active magnetic coil on left dorsolateral prefrontal cortex.
Sponsors
Universiti Putra Malaysia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double blinded
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in mean monthly migraine days. | Baseline and month 1, 2 and 3 post treatment | The mean monthly migraine days will be calculated using the monthly migraine days from each of the month of the double-blind treatment phase. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects with at least a 50% reduction from baseline in mean monthly migraine days. | Baseline and month 1, 2 and 3 post treatment | 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. |
| Frequency and severity of adverse events in response to rTMS. | During treatment and up until 1 month post treatment | Recorded any adverse events as per Good Clinical Practice Guideline and Declaration of Helsinki. |
| The Depression Anxiety Stress Scale (DASS 21) score changes in migraine patients in response to rTMS. | Baseline and at month 3 post treatment | Mean score changes from baseline for depression, anxiety and stress category. |
| The Migraine Disability Assessment Test (MIDAS) score changes in migraine patients in response to rTMS. | Baseline and at month 3 post treatment | Mean score changes from baseline. |
| The Migraine Specific Questionnaire (MSQ) version 2.1 score changes in migraine patients in response to r-TMS. | Baseline and at month 3 post treatment | Mean score changes from baseline. |
| The EQ-5D score changes in migraine patients in response to rTMS. | Baseline and at month 3 post treatment | Mean score changes from baseline. |
| The Pittsburgh Sleep Quality Index score changes in migraine in response to rTMS. | Baseline and at month 3 post treatment | Mean score changes from baseline for sleep quality. |
| Change from baseline in mean monthly migraine attacks. | Baseline and month 1, 2 and 3 post treatment | The mean monthly migraine attacks will be calculated using the monthly migraine attack from each of the month of the double-blind treatment phase. |
| The Global Physical Activity Questionnaire score change in migraine in response to rTMS. | Baseline and at month 3 post treatment | Mean score changes from baseline. |
| Transcranial Doppler (TCD) pattern changes in migraine patients in response to rTMS. | Baseline and at month 3 post treatment | Mean flow velocity (cm/s). |
| Electroencephalography (EEG) pattern change in migraine patients in response to rTMS. | Baseline and at month 3 post treatment | EEG pattern differences based on report. |
| Serum serotonin level in migraine patients in response to rTMS. | Baseline and at month 3 post treatment | Serum serotonin (ng/ml). |
| Serum beta-endorphin level changes in migraine patients in response to rTMS. | Baseline and at month 3 post treatment | Serum beta endorphin (ng/ml). |
| Serum Calcitonin gene related peptide (CGRP) level in migraine patients in response to rTMS. | Baseline and at month 3 post treatment | Serum CGRP (pg/ml). |
| Satisfaction measures of efficacy, tolerability, safety and expectations of rTMS among the participants. | At month 3 post treatment | A 5-point, Likert scale will be used to evaluate satisfaction with rTMS in migraine prevention. |
| The Food Frequency Questionnaire score in migraine patients | Baseline | Measuring food frequency intake at baseline |
Countries
Malaysia
Outcome results
None listed