261: Transcranial Magnetic Stimulation Combined with Mindfulness for Pain Relief in Women with Migraine

Topic: Clinical Science
Subtopic: Pain category (ICD-11), Chronic primary headache, Non-pharmacological treatments, Physiotherapy (e.g. exercise, rehab), Neuromodulation (e.g. TMS, TDCS, FUS, SCS, MCS, DBS, vagus nerve stimulation)

Background and Aims: Repetitive Transcranial Magnetic Stimulation (rTMS) and Mindfulness have independently been shown to be associated with lower levels and frequency of headaches¹. To date, there is a clear gap in the literature regarding the combined use of these interventions for migraine. Therefore, this study aims to assess the feasibility, regarding recruitment, retention, adherence, safety, and acceptability of a 4-week randomized clinical trial (RCT) combining rTMS and Mindfulness for the treatment of pain, disability, mindfulness state, depression, and anxiety in women with migraine.

Methods: This pilot randomized, double-blind, parallel, single-center study allocated 24 women (18–65 years) with ≥1 year of migraine into two groups (1:1). Participants received active repetitive transcranial magnetic stimulation (rTMS) or sham stimulation. Eight sessions were conducted over four weeks (twice weekly). Stimulation was delivered over F3 at 110% of the motor threshold, totaling 1,600 pulses (32 trains of 5 s, 10 Hz, 50 pulses/train) with 30-s inter-train intervals, for 20 minutes. After stimulation, participants completed guided mindfulness meditation. Primary outcomes included feasibility measures monitored throughout the study. Secondary outcomes were assessed 30 days pre-intervention, at baseline, post-intervention, and at 30-day follow-up using the Brief Pain Inventory (BPI), Headache Impact Test (HIT-6), Migraine Disability Assessment (MIDAS), Depression, Anxiety and Stress Scale (DASS-21), Five Facet Mindfulness Questionnaire (FFMQ), and a pain diary. The study was approved (CAAE: 77642124.6.0000.5060; ReBEC: RBR-2md8855). Statistical significance was set at p < 0.05.

Results: Primary outcomes were as follows: recruitment 72.72%, retention 91.66%, adherence 83.33%, and acceptability 100% (mean satisfaction 9.52). Regarding safety, 14 mild adverse effects occurred across 160 sessions. Despite one dropout per group, all participants were analyzed under the intention-to-treat principle. Secondary outcomes showed small to large effect sizes. Pain intensity (Brief Pain Inventory, BPI) showed large effects (sensory d = 1.55; affective d = 1.70). Quality of life (Headache Impact Test, HIT-6™) showed a moderate effect (d = 0.78). Migraine-related disability (Migraine Disability Assessment, MIDAS) showed a moderate effect (d = 0.65). The Depression, Anxiety, and Stress Scale (DASS-21) showed effects of d = 1.53, 0.33, and 0.22. The Five Facet Mindfulness Questionnaire (FFMQ) ranged from d = 0.12 to 0.88. Pain diary outcomes included days with pain (d = 0.59) and medication use (d = 1.36).

Conclusions: The results of the present study demonstrate that it is feasible, in terms of recruitment, retention, adherence,safety, and acceptability, to conduct a 4-week randomized clinical trial combining repetitive transcranial magnetic stimulation with mindfulness-based meditation practices for the treatment of pain, disability, mindfulness state, depression, and anxiety in women with migraine. Recruitment, retention, and adherence rates were considered successful and favorable for progression to a large-scale study.

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Presenting Author: Fernanda Moura Vargas Dias
Submitting Author: FERNANDA MOURA VARGAS DIAS

Senior Author: Fernanda Moura Vargas Dias

IASP 2026 Global Year theme of Neuropathic Pain: No

• Christian Nogueira de Barros: Graduate - Center of Health Sciences, Federal University of Espírito Santo, ES, Brazil.
• Felipe Mendes Barcelos Angeli: Graduate - Center of Health Sciences, Federal University of Espírito Santo, ES, Brazil.
• Carolina Anhoque Comarela Fiorin: PhD - Center of Health Sciences, Federal University of Espírito Santo, ES, Brazil.
• Fernando Zanela da Silva Âreas: PhD - Baylor Scott and White Research Institute | Institute For Rehabilitation, Dallas, Texas, USA.