Administrative information
Title {1} | 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 (MAGNET-EM). |
Trial registration {2a and 2b} | ClinicalTrials.gov NCT03556722. |
Protocol version {3} | 01/10/2019 Version 4. |
Funding {4} | This work is supported by Research Management Centre, Universiti Putra Malaysia (Grant Number GPB/2017/9585500). |
Author details {5a} | 1. Department of Medicine, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, 43400 UPM Serdang, Selangor, Malaysia. 2. Malaysian Research Institute on Ageing, Universiti Putra Malaysia, 43400 UPM Serdang, Selangor, Malaysia. 3. Department of Pathology, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, 43400 UPM Serdang, Selangor, Malaysia. 4. Department of Psychiatry, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, 43400 UPM Serdang, Selangor, Malaysia. 5. Department of Surgery, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, 43400 UPM Serdang, Selangor, Malaysia. 6. Department of Family Medicine, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, 43400 UPM Serdang, Selangor, Malaysia. 7. Avisena Specialist Hospital, Medical Department Jalan Ikhtisas, Seksyen 14, 40000 Shah Alam, Selangor, Malaysia. |
Name and contact information for the trial sponsor {5b} | Professor Dr Mohd Adzir Mahdi Telephone No.: (+60) 397691610 Fax No.:(+60) 397691610 Email: dir.rmc@upm.edu.my |
Role of sponsor {5c} | Providing fund, implement quality control and quality assurance, monitoring the progress of the research trial, review the recorded data and ensuring the researchers comply to the study protocol. |
Introduction
Background and rationale {6a}
Objectives {7}
Trial design {8}
Methods: participants, interventions and outcomes
Study setting {9}
Eligibility criteria {10}
Who will take informed consent? {26a}
Additional consent provisions for collection and use of participant data and biological specimens {26b}
Interventions
Explanation for the choice of comparators {6b}
Intervention description {11a}
Criteria for discontinuing or modifying allocated interventions {11b}
Strategies to improve adherence to interventions {11c}
Relevant concomitant care permitted or prohibited during the trial {11d}
Provisions for post-trial care {30}
Outcomes {12}
Participant timeline {13}
Study visit | V1 | V2 | V3 | V4 | V5 | V6 | V7 | V8 | V9 | V10 |
---|---|---|---|---|---|---|---|---|---|---|
Check eligibility | X | X | ||||||||
Questionnaires | X | X | ||||||||
Study intervention | X | X | X | X | X | |||||
Randomisation | X | |||||||||
Laboratory test | X | X | ||||||||
Headache diary | X | X | X | X | ||||||
AE monitoring | X | X | X | X | X | X | X | X | ||
EEG | X | X | ||||||||
TCD | X | X |