Pain, neuroinflammation
Conditions
Interventions
Study type this study will be a controlled randomized clinical trial the population for this research will consist of women diagnosed with migraines the age range of the participants will be from 18 t
E02.190.204
Sponsors
Sociedade de Educação Superior e Cultura Brasil S.A.
Sociedade de Educação Superior e Cultura Brasil S.A.
Eligibility
Sex/Gender
Female
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Medical diagnosis of migraine with a minimum duration of one year; women; aged between 18 and 60 years; agreement to participate in the study; formalization of participation through the signing of the Informed Consent Form (ICF)
Exclusion criteria
Exclusion criteria: Women diagnosed with tension headache; other pain syndromes; pregnant women; continuous use of anti-inflammatory drugs; antidepressants; or analgesics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of this study is the reduction in pain intensity in patients with migraine, assessed through the McGill Pain Questionnaire, which measures pain both qualitatively and quantitatively, using sensory, affective, and evaluative categories, with scores that vary according to pain intensity, where higher scores indicate more intense pain. Additionally, the frequency of migraine attacks will be evaluated, recorded in the digital migraine diary, which monitors the occurrence, duration, intensity, and impact of the attacks on daily activities. | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of prefrontal cortex hemodynamics. Prefrontal cortex hemodynamics will be assessed through blood oxygenation, using the HEG® medical device (BioTekna Co, Italy), which is a Near-Infrared Spectroscopy (NIRS) device, equipped with dual wavelength light-emitting diode sources (660 and 940 nm). This device has a sensor placed on the participant's forehead, with a distance of 1.5 cm between the light source and the detector, covering the central prefrontal area. During the procedure, participants will be comfortably positioned in a chair, with their arms supported, and the ambient temperature will be kept constant at around 22°C. The sensors will be placed in the central region of the frontal bone (Figure 9), about 2 cm above the nasal bone. Once the correct positioning and adequate signal capture are confirmed, the data will be recorded. During this recording, participants will be instructed to remain in an active relaxation state, keeping their eyes open while the signal is acquired and displayed on the computer screen. The outcomes related to cortical activation will be measured by the cerebral blood oxygenation ratio (rCBO2) and cerebral blood flow (CBF), calculated from the average data recorded during five minutes. The measured variables will include the mean, minimum, maximum, standard deviation, and slope of rCBO2. ;Evaluation of Autonomic Nervous System Activity. To evaluate the activity of the autonomic nervous system (ANS), we will use heart rate variability (HRV) assessment, utilizing the medical device PPG Stress Flow® (BioTekna Co, Italy), registered with the Italian Ministry of Health under the national classification of medical devices CND: Z12040113. The PPG Stress Flow® is an optoelectronic plethysmograph designed to measure blood volume variation and perform HRV analysis and biofeedback in ANS studies. For measurements, the participant will be positioned comfortably with their forearms resting on a table in a quiet environment. Two finger | — |
Countries
Brazil
Contacts
Public ContactFernanda Belle
Universidade do Sul de Santa Catarina
Outcome results
None listed