Brain Stimulation with Light for Chronic Migraine

INTERVENTION: This study is a randomized, prospective, two‐arm, blinded clinical trial comparing the efficacy and tolerability of transcranial photobiomodulation (t‐PBM) versus sham stimulation (control group) in reducing pain in patients with chronic migraine. The protocol was approved by the Research Ethics Committee of the Maurício de Nassau University, opinion 6.493.592, and conducted in accordance with the Declaration of Helsinki, as well as the Resolutions of the National Health Council No. 466/12 and No. 510/16; all participants signed the Informed Consent Form, guaranteeing confidentiality and use of data exclusively for scientific purposes. There was no financial burden on the participants. The sample consisted of 72 individuals, randomized by randomization of participants in a 1:1 ratio between the experimental group and the control group, 36 participants in each group. The blinding of this study was single‐blind, and participants were recruited by convenience at the Neurology Outpatient Clinic of the Mendo Sampaio Municipal Hospital, BR‐101 South, km 34, Charneca, Cabo de Santo Agostinho‐PE. Adults (=18 years) of both sexes with a diagnosis of chronic common migraine were included. Pregnant women, epileptics, individuals with sequelae of stroke (acute/subacute), history of analgesic abuse or catamenial headache were excluded. Participants allocated to the experimental (active) group received transcranial photobiomodulation (t‐PBM) with a HEAD‐UP helmet containing 256 infrared light‐emitting diodes (LEDs) of 810 nm, 50 mW per diode (total power 12.8 W). Continuous mode and 100% emission capacity, applied to the entire skull. Each session lasted 20 minutes, performed three times a week for four weeks (total of 10 sessions). The control group received the same intervention wi CONDITION: C10.228.140.546.399.750 Migraine without aura PRIMARY OUTCOME: Expected outcome 1: A reduction in the number of days with pain is expected 30 days after the intervention is completed, adjusted for baseline Outcome finding 1 showed a significant reduction to 9.78 ± 7.12 days per month compared to the baseline of 16 days of pain per month (median 7.00), representing an absolute decrease of 6.22 days and a percentage reduction of 38.9%. Data were collected 30 days after the completion of treatment through the completion of a migraine diary SECONDARY OUTCOME: Secondary outcome a positive impact on the quality of life of patients treated with photobiomodulation was observed; this improvement was seen in both the active and control groups, with a trend towards superiority in the active group, as assessed by the SF‐36 (Short Form Health Questionnaire) with 36 items INCLUSION CRITERIA: Volunteers of both sexes aged between 18 and 90 years; with more than 15 migraine days per month; using migraine prophylaxis medication in the last three months