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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 : June 14, 2018
Sponsor:
Information provided by (Responsible Party):
Wan Aliaa Wan Sulaiman, Universiti Putra Malaysia

Brief Summary:
This study will assess the safety and efficacy of repetitive transcranial magnetic stimulation (rTMS) for the treatment of migraine.

Condition or disease Intervention/treatment Phase
Migraine Device: Repetitive Transcranial Magnetic Stimulation. Device: Sham rTMS Not Applicable

Detailed Description:
Migraine patients according to International Headache Society criteria will be allocated randomly into two treatment arms. 1 group will receive Active rTMS and 1 group will receive sham rTMS for intensive treatment phase of 2 months (12 sessions) then for maintenance phase of 3 months (9 sessions).Assessment will be made at baseline, after intensive phase then after maintenance phase.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
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
Primary Purpose: Treatment
Official Title: Effectiveness and Tolerability of Repetitive Transcranial Magnetic Stimulation in Migraine Prophylaxis: A Randomized, Double Blinded Controlled Trial
Estimated Study Start Date : August 2018
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.

  2. 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).


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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)

  4. 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)

  5. 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

  6. 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.

  7. 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.

  8. 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.

  9. 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



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Migraine patients having more than or equal 3 attacks per month were included

Exclusion Criteria:

  • Age less than ≤18 years
  • Headache less than 12 months duration
  • Pregnant or lactating women
  • Patients with metallic implant and pacemaker
  • Patients with medical conditions such severe hypertension, seizure, renal failure, hepatic failure, bleeding diathesis

Information from the National Library of Medicine

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


Contacts
Contact: Wan Aliaa B. Wan Sulaiman, Assoc. Prof. +60386092980 ext + 60134888405 wanaliaa@upm.edu.my
Contact: Alaa M Hafez, PhD student +60173656047 alaahafez2487@gmail.com

Locations
Malaysia
University Putra Malaysia Active, not recruiting
Serdang, Selangor, Malaysia, 43400
Sponsors and Collaborators
Universiti Putra Malaysia
Investigators
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

Responsible Party: Wan Aliaa Wan Sulaiman, Associate Professor, Universiti Putra Malaysia
ClinicalTrials.gov Identifier: NCT03556722     History of Changes
Other Study ID Numbers: GPB/2017/9585500
First Posted: June 14, 2018    Key Record Dates
Last Update Posted: June 14, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wan Aliaa Wan Sulaiman, Universiti Putra Malaysia:
Repetitive Transcranial Magnetic Stimulation
Transcranial Doppler
Neuromodulation
Randomized Controlled Trials
Pain
Migraine prophylaxis
Dorsolateral Prefrontal Cortex
Protocol

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases