Single-centre, randomised and double-blind clinical trial on the efficacy of transcutaneous auricular vagus nerve stimulation in preventing and treating primary headache in children and adolescents: a study protocol
Abstract
Introduction: Primary headaches pose a significant burden on children and adolescents, highlighting the need for effective non-pharmacological interventions. Transcutaneous auricular vagus nerve stimulation (taVNS) is a non-invasive modality that has demonstrated efficacy in adult populations with primary headaches and has shown safety in adolescents with mental health disorders. However, its effectiveness in managing acute headache episodes and preventing recurrences in paediatric populations remains underexplored. This study aims to evaluate the immediate analgesic effects of taVNS during acute headache episodes and its preventive efficacy over a 4-week period. Additionally, we will investigate potential biomarkers associated with primary headaches and elucidate the underlying mechanisms of taVNS through electromyography (EMG) and electrocardiography (ECG) assessments.
Methods and analysis: This study will employ a double-blind, randomised clinical trial design involving 288 children and adolescent participants diagnosed with primary headaches. The study will consist of two substudies: the acute period (AP) study and the preventive period (PP) study. Participants will be randomly allocated to receive either taVNS or sham stimulation. The primary outcome for the AP study will be the reduction of pain intensity 2 hours after treatment, as measured by the visual analogue scale, while the PP study will assess the change in the headache attack days over the treatment period.…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 288 participants or records.
Read the paper
Related studies
- Calcium Ions in the Physiology and Pathology of the Central Nervous System
- AI-powered in silico twins: redefining precision medicine through simulation, personalization, and predictive healthcare
- In silico functional, structural and pathogenicity analysis of missense single nucleotide polymorphisms in human MCM6 gene
- In Silico drug repurposing pipeline using deep learning and structure based approaches in epilepsy
- Targeting serotonin receptors with phytochemicals – an in-silico study
- In silico exploration of anti-prostate cancer compounds from differential expressed genes
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.