Transcranial magnetic stimulation combined with mindfulness for pain and disability management in migraine patients: a protocol feasibility study

Migraine is the second leading cause of disability worldwide, contributing to high healthcare costs, reduced work productivity, and diminished quality of life. Non-pharmacological therapies such as repetitive transcranial magnetic stimulation (rTMS) and mindfulness-based practices (MBPs) have independently demonstrated effectiveness in reducing headache frequency and medication use, offering safer and more tolerable alternatives to pharmacological treatments. This study aims to evaluate the feasibility of a randomized controlled trial (RCT) combining rTMS and MBPs for the management of pain and disability in women with chronic migraine. This double-blind, parallel-group, randomized protocol will include 24 participants assigned in a 1:1 ratio to either a sham group (sham rTMS + mindfulness) or an active intervention group (rTMS + mindfulness). Each participant will undergo eight sessions over four weeks, with assessments conducted at baseline and 30-day follow-up. Outcomes will include measures of pain, disability, mindfulness, anxiety, depression, acceptability, adherence, and safety, collected through validated questionnaires and session logs. In this trial, participants, outcome assessors, and data analysts will be blinded to group allocation. Due to the nature of the intervention, therapists administering rTMS cannot be blinded. Thus, the study is defined as double-blind rather than triple-blind. Feasibility outcomes will include recruitment and retention rates, protocol compliance, randomization and blinding success, and occurrence of adverse events. The results will inform the design of a larger-scale RCT. Given the potential of both rTMS and mindfulness in migraine treatment, their combination may lead to meaningful improvements in symptom management and quality of life in individuals with chronic migraine.