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Transcranial Magnetic Stimulation in Episodic Migraine (Magnet-EM) (Magnet-EM)

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ClinicalTrials.gov Identifier: NCT03556722
Recruitment Status : Recruiting
First Posted : June 14, 2018
Last Update Posted : May 7, 2019
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 (r-TMS) as new preventive treatment of migraine.

Condition or disease Intervention/treatment Phase
Migraine Device: Repetitive Transcranial Magnetic Stimulation. Device: Sham r-TMS 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 r-TMS and 1 group will receive sham r-TMS for treatment phase (5 sessions). Assessment will be made at baseline (month 1), month 2 (1 month after first treatment session), month 3 and month 4.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
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 For Preventive Treatment Of Episodic Migraine: A Single Centre, Randomised, Double-Blind, Sham-Controlled Phase 2 Trial
Actual Study Start Date : April 15, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arm Intervention/treatment
Active Comparator: Active r-TMS
Active r-TMS on left dorsolateral prefrontal cortex.
Device: Repetitive Transcranial Magnetic Stimulation.
High frequency r-TMS on left dorsolateral prefrontal cortex.
Other Name: r-TMS

Sham Comparator: Sham r-TMS
Placebo r-TMS on left dorsolateral prefrontal cortex
Device: Sham r-TMS
Sham r-TMS without the active magnetic coil on left dorsolateral prefrontal cortex
Other Name: Placebo




Primary Outcome Measures :
  1. Change from baseline in mean monthly migraine days. [ Time Frame: 4 months after the first session of r-TMS ]
    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 Outcome Measures :
  1. Change from baseline in mean monthly migraine attacks. [ Time Frame: 4 months after the first session of r-TMS ]
    The mean monthly migraine attacks will be calculated using the monthly migraine attack from each of the month of the double-blind treatment phase.

  2. Proportion of subjects with at least a 50% reduction from baseline in mean monthly migraine days. [ Time Frame: 4 months after the first session of r-TMS ]
    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.

  3. Frequency and severity of adverse events in response to r-TMS. [ Time Frame: 4 months after the first session of r-TS ]
    Recorded any adverse events as per Good Clinical Practice Guideline and Declaration of Helsinki

  4. The Depression Anxiety Stress Scale (DASS 21) score changes in migraine patients in response to r-TMS. [ Time Frame: 4 months after the first session of r-TMS ]
    Mean score changes from baseline for depression, anxiety and stress category.

  5. The Migraine Disability Assessment Test (MIDAS) score changes in migraine patients in response to r-TMS. [ Time Frame: 4 months after the first session of r-TMS ]
    Mean score changes from baseline.

  6. The Migraine Specific Questionnaire (MSQ) version 2.1 score changes in migraine patients in response to r-TMS. [ Time Frame: 4 months after first session of r-TMS ]
    Mean score changes from baseline.

  7. The EQ-5D score changes in migraine patients in response to r-TMS. [ Time Frame: 4 months after first session of r-TMS ]
    Mean score changes from baseline.

  8. The A-B Neuropsychological Assessment Schedule score changes in migraine in response to r-TMS. [ Time Frame: 4 months after first session of r-TMS ]
    Mean score changes from baseline.

  9. The Pittsburgh Sleep Quality Index score changes in migraine in response to r-TMS. [ Time Frame: 4 months after first session of r-TMS ]
    Mean score changes from baseline for sleep quality.

  10. The Food Frequency Questionnaire score changes in migraine in response to r-TMS. [ Time Frame: 4 months after first session of r-TMS ]
    Mean score changes from baseline.

  11. The International Physical Activity Questionnaire score change in migraine in response to r-TMS. [ Time Frame: 4 months after first session of r-TMS ]
    Mean score changes from baseline.

  12. Transcranial Doppler (TCD) pattern changes in migraine patients in response to r-TMS. [ Time Frame: Baseline and after treatment sessions (month 4) ]
    Mean flow velocity (cm/s).

  13. Electroencephalography (EEG) pattern change in migraine patients in response to r-TMS. [ Time Frame: Baseline and after treatment sessions (month 4) ]
    EEG pattern differences based on report.

  14. Serum serotonin level and DNA changes in migraine patients in response to r-TMS. [ Time Frame: Baseline and after treatment sessions (month 4) ]
    Serum serotonin (ng/ml).

  15. Serum beta-endorphin level changes in migraine patients in response to r-TMS. [ Time Frame: Baseline and after treatment sessions (month 4) ]
    Serum beta endorphin (ng/ml).

  16. C-Reactive Protein (CRP) level changes in migraine patients in response to r-TMS. [ Time Frame: Baseline and after treatment sessions (month 4) ]
    Serum CRP mg/dL

  17. Serum Calcitonin gene related peptide (CGRP) level and DNA changes in migraine patients in response to r-TMS. [ Time Frame: Baseline and after treatment sessions (month 4) ]
    Serum CGRP pg/mL

  18. Satisfaction measures of efficacy, tolerability, safety and expectations of r-TMS among the participants. [ Time Frame: 4 months after first session of r-TMS ]
    A 5-point, Likert scale will be used to evaluate satisfaction with r-TMS in migraine prevention.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 r-TMS treatment.
  2. Onset of headache more than 50 years
  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 r-TMS candidate.
  6. Patients on anti-psychotics or anti-depressant medications.
  7. Patients with medical conditions such severe hypertension, infections, malignancy, cardiovascular and cerebrovascular disease, epilepsy degenerative central nervous system diseases, renal failure, hepatic failure, bleeding diasthesis and major psychiatric disease.

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
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Contact: Wan Aliaa B. Wan Sulaiman, MRCP +60386092980 ext + 60134888405 wanaliaa@upm.edu.my
Contact: Nabil Izzaatie B. Mohamad Safiai, Master +60189474202 nabil.izzaatie@student.upm.edu.my

Locations
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Malaysia
University Putra Malaysia Recruiting
Serdang, Selangor, Malaysia, 43400
Contact: Wan Aliaa B. Wan Sulaiman, MRes    +603 8609 2980    wanaliaa@upm.edu.my   
Sub-Investigator: Nabil Izzaatie B. Mohamad Safiai, Master         
Sub-Investigator: Nur Ain B. Amir, Degree         
Sponsors and Collaborators
Universiti Putra Malaysia
Investigators
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Study Chair: Hamidon B. Basri University Putra Malaysia
Study Director: Wan Aliaa B. Wan Sulaiman, MRCP Universiti Putra Malaysia
Principal Investigator: Wan Aliaa B. Wan Sulaiman, MRCP Universiti Putra Malaysia

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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: May 7, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases