Transcranial magnetic stimulation combined with mindfulness for pain and disability management in migraine patients: a protocol feasibility study
Fernanda Moura Vargas Dias, Renata Goltara Liboni Vescovi, Carolina Fiorin Anhoque, Maria Eduarda Pinheiro Dos Santos, Christian Nogueira de Barros, Iaryssa Iris de Souza, Walter Gomes da Silva Filho, Jocemar Ilha, Fernando Zanela da Silva Arêas
MethodsX November 30, 2025 DOI: 10.1016/j.mex.2025.103681 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized controlled trial protocol (feasibility, double-blind, parallel-group) Peer reviewed |
|---|---|
| Sample size | 24 |
| Population | Women with chronic migraine |
| Interventions | Repetitive transcranial magnetic stimulation (rTMS) mindfulness-based practices (MBPs) |
| Duration | Eight sessions over four weeks, with 30-day follow-up |
| Topics | Meditation |
| Keywords | Migraine Neuromodulation Transcranial magnetic stimulation Chronic pain |
| Key findings | The protocol proposes that combining rTMS with mindfulness-based practices may improve symptom management and quality of life in chronic migraine, and aims to test the feasibility of a full-scale randomized trial by assessing recruitment, retention, compliance, blinding success, and adverse events in 24 women. |
Abstract
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.
Comparable studies
Other randomized controlled trials on meditation, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Alterations in Brain and Immune Function Produced by Mindfulness Meditation Healthy employees in a work environment | 2003 | Randomized controlled trial | n = 41 |
| Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. Recovered recurrently depressed patients | 2000 | Randomized controlled trial | n = 145 |
| Open hearts build lives: Positive emotions, induced through loving-kindness meditation, build consequential personal resources. Working adults | 2008 | Randomized controlled trial | n = 139 |
| Short-term meditation training improves attention and self-regulation Undergraduate Chinese students | 2007 | Randomized controlled trial | n = 40 |
| Mindfulness-Based Cognitive Therapy for Depression: Replication and Exploration of Differential Relapse Prevention Effects. Recovered recurrently depressed patients | 2004 | Randomized controlled trial | n = 73 |
Citations in the library
Cites 7
- Construct Validity of the Five Facet Mindfulness Questionnaire in Meditating and Nonmeditating Samples Assessment February 29, 2008
- Mindfulness in migraine: A narrative review Expert Review of Neurotherapeutics January 14, 2020
- Neuromodulation and meditation: A review and synthesis toward promoting well-being and understanding consciousness and brain. Neuroscience & Biobehavioral Reviews August 1, 2024
- Efficacy of mindfulness-based intervention for the treatment of chronic headaches: A systematic review and meta-analysis. Annals of Medicine and Surgery June 2022
- Audio-Guided Mindfulness Meditation During Transcranial Magnetic Stimulation Sessions for the Treatment of Major Depressive Disorder: A Pilot Feasibility Study Frontiers in Psychology August 17, 2021
and 2 more in the library