The main objective of this clinical trial is to evaluate the therapeutic effects of transcranial direct current stimulation associated with the practice of mindfulness in the prophylaxis of the painful symptomatology of chronic migraine because previous studies have shown that the administration of tDCS with concomitant development of tasks can improve behavioral results [30].
In the current scientific literature, favorable results have been reported in previous clinical trials administering tDCS to patients with migraine, as an improvement in pain intensity, a decrease in the occurrence and duration of new crises, and a decrease in the need for drugs was observed. This technique modulates the excitability and excessive cortical-neural overresponsiveness inherent to this pathology and has been used as an abortive or prophylactic treatment, enabling the use of lower amounts of acute drugs [19].
The use of mindfulness as a therapeutic practice was also shown to be safe and viable in adults with chronic migraine [31], revealing a reduction in functional disability and suffering related to migraine [32] and promoting greater awareness, disidentification with self, greater optimism related to sensations and feelings [33], reducing relapses by minimizing factors that trigger seizures such as anxiety and stress, increasing resilience to stress and effective regulation of the heart rate [34] and improving the perception of pain intensity and quality [35]. In addition, this therapy produces similar results to conventional pharmacological prophylaxis, thereby reducing the consumption of acute medications and the levels of inflammatory biomarkers [6].
The aim of this study is to analyze and compare the degree of disability in chronic migraineurs while performing daily life activities, the impact of daily headaches, and participants’ levels of attention in the pre- and postintervention periods (immediately after the end of the sessions and one month after the conclusion of the sessions) as a method to assess the prophylactic effect of the two strategies administered simultaneously in this clinical context. The pathophysiological mechanism of this disease remains unclear, although the main current explanation for this disease is attributed to typical neurological changes [36].
Another objective is to evaluate changes in brain waves after joint treatment using the portable EEG.
Using the MIDAS questionnaire, we expect that the administration of the combination of tDCS and mindfulness interventions will promote a decrease in the degree of disability of patients with chronic migraine in the performance of activities of daily living (ability to perform household tasks, to have a healthy social life, to go to work without missing work days, etc.) because it prophylaxis for pain associated with new episodes of migraine. The data obtained from the HIT-6 are expected to reveal an improvement in the assessment of the impact of headache on the daily life of these patients. As another outcome, an increase in the level of mindfulness of these patients is expected before and after the intervention, as evidenced by the FFMQ-BR, thus reflecting a greater awareness of the present moment and the subsequent disidentification with painful symptoms, minimizing the suffering participants experience.
Regarding the electrophysiological data obtained in the present study, the brain wave patterns observed using the portable EEG are predicted to change, consistent with the results of the assessment instruments. Dynamic changes in the power and connectivity detected by the EEG have been observed in patients with migraine in previous studies supported by resting-state fMRI [37].
As main limiting factors, dropout or exclusion of participants may occur, as the required frequency of laboratory visits will be three times a week for four consecutive weeks, with a tolerance of two consecutive absences or three alterante absences with the necessary replacements, despite the provision of flexible schedules, direct contact and contact via telephone in an attempt to reinforce adherence of the participants.
Participants may also fail to perform or incompletely perform the domiciliary practices of mindfulness, despite the adoption of registration strategies (availability of a spreadsheet to record the time, date and if the practice was completely performed at home), the availability through a WhatsApp group of the audio recordings used in the intervention and the incentive to perform these personal practices.
Because a conventional pharmacological treatment only achieves favorable results in 50% of users and may cause side effects [18], more effective therapeutic alternatives with fewer adverse effects are necessary. The study of the concomitant administration of tDCS and mindfulness, both of which have already been established individually as treatments for chronic migraine, is unprecedented and may benefit patients with migraine by providing a low-cost, safe and effective treatment, in addition to enriching the scientific literature on this topic.