Migraine Reduction Study Using Repetitive Transcranial Stimulation (MRSTIMAS)
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|ClinicalTrials.gov Identifier: NCT03556722|
Recruitment Status : Not yet recruiting
First Posted : June 14, 2018
Last Update Posted : October 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Migraine||Device: Repetitive Transcranial Magnetic Stimulation. Device: Sham rTMS||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Two-arm parallel assignment involves two groups of participants. One group receives rTMS, and the other group receives sham placebo rTMS.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||Double blinded|
|Official Title:||Effectiveness and Tolerability of Repetitive Transcranial Magnetic Stimulation in Migraine Prophylaxis: A Randomized, Double Blinded Controlled Trial|
|Estimated Study Start Date :||December 2018|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||June 2020|
Active Comparator: Active rTMS
Active rTMS on left dorsolateral prefrontal cortex.
Device: Repetitive Transcranial Magnetic Stimulation.
High frequency rTMS on left dorsolateral prefrontal cortex.
Other Name: rTMS
Sham Comparator: Sham rTMS
Placebo rTMS on left dorsolateral prefrontal cortex
Device: Sham rTMS
Sham rTMS without the active magnetic coil on left dorsolateral prefrontal cortex
Other Name: Placebo
- Change from baseline headache frequency at 3 months [ Time Frame: Baseline headache frequency then at month 3 ]Number of days with migraine attacks per month by using monthly headache diary given to patients.
- Change from baseline headache severity by Visual Analogue Scale (VAS) at 3 months [ Time Frame: Baseline headache severity then at month 3 ]VAS measures the amount of pain that a patient feels which ranges across a continuum from none to an extreme amount of pain .Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity using the following cut points: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).
- Changes of transcranial Doppler (TCD) parameters in migraine patients in response to rTMS. [ Time Frame: TCD before and after one rTMS session at week 1,3,5,7 in first two months then at month 4,5.6 then once at month 9,12. ]Measure mean flow velocity of major intracranial vessels
- Changes in scalp electroencephalogram (EEG) in migraine patients in response to rTMS. [ Time Frame: EEG done at baseline (month 0) and then at month 2,6 and 12. ]Measure the frequency of brain electrical activity
- Serum serotonin level change in migraine patients in response to rTMS. [ Time Frame: Baseline (month 0) and after intensive treatment sessions (month 2). ]Serum serotonin (ng/ml)
- Serum beta-endorphin level change in migraine patients in response to rTMS [ Time Frame: Baseline (month 0) and after intensive treatment sessions (month 2). ]Serum beta-endorphin (ng/ml)
- C-Reactive Protein (CRP) level change in migraine patients in response to rTMS [ Time Frame: Baseline (month 0) and after intensive treatment sessions (month 2). ]Serum CRP mg/dL
- Number of migraine patients with adverse effects of rTMS. [ Time Frame: Through study completion, an average of 1 year. ]Based on recording of patient's complains.
- Efficacy of maintenance protocol for rTMS treatment in migraine by reducing number of attacks [ Time Frame: After maintenance sessions within 3 months (9 sessions). ]Based on migraine days per month using headache diary determined by equal or more than 50 % reduction in number of headache days.
- Efficacy of maintenance protocol for rTMS treatment in migraine by reducing migraine severity. [ Time Frame: After maintenance sessions within 3 months (9 sessions). ]Based on Visual Analogue Scale determined by equal or more than 50 % reduction in baseline score.
- Calcitonin gene related peptide (CGRP) level change in migraine patients in response to rTMS [ Time Frame: Baseline (month 0) and after all sessions (month 6) ]Serum CGRP pg/mL
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03556722
|Contact: Wan Aliaa B. Wan Sulaiman, Assoc. Prof.||+60386092980 ext + email@example.com|
|Contact: Alaa M Hafez, PhD firstname.lastname@example.org|
|University Putra Malaysia||Active, not recruiting|
|Serdang, Selangor, Malaysia, 43400|
|Study Chair:||Hamidon B. Basri, Professor||University Putra Malaysia|
|Study Director:||Wan Aliaa B Wan Sulaiman||Universiti Putra Malaysia|
|Principal Investigator:||Alaa M Hafez, PhD student||Universiti Putra Malaysia|