Visual respiratory biofeedback to improve visuospatial cognition and cardiac interoception in migraineurs: a study protocol for a randomized controlled trial.

OBJECTIVES: Migraine is a complex neurological disorder that typically presents with unilateral cephalgia associated with cognitive impairment and reduced interoception. These symptoms result in socio-economic repercussions due to reduced productivity, efficiency, and work performance. Therefore, along with headache management, improving cognition and interoception should also be significant therapeutic targets to effectively manage migraine. To achieve this, we propose to explore the role of a yoga-based visual respiratory biofeedback (VRB) as a possible therapeutic strategy.

METHODS AND ANALYSIS: At least 64 participants will be recruited for the trial after screening for eligibility criteria, using the migraine screening questionnaire and Montreal cognitive assessment test. They will be randomly allocated (1:1) to either the experimental group receiving a 20-min session of yoga-based VRB or the control group who will be asked to watch a documentary film for the same duration. Visuospatial cognition will be assessed by the Corsi block-tapping task, and cardiac interoceptive accuracy will be assessed by the heartbeat counting task at baseline and immediately after the intervention. Based on the distribution and variance of the data obtained, analysis will be conducted based on linear mixed models using SPSS version 28.0.1.0, with a two-sided p -value of < 0.05 considered to be statistically significant.

DISCUSSION: To the best of our knowledge, this is the first study to design and assess the effects of yoga-based biofeedback therapy on cognition and cardiac interoception in migraineurs. Furthermore, we postulated that pranayama's therapeutic effects might be enhanced by using visual yogic respiratory biofeedback. Considering the socio-economic burden of migraine, if found effective, VRB investigated in the trial could be considered as a therapeutic strategy.

CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov CTRI, CTRI/2023/03/050430.