Safety and efficacy of transcutaneous auricular vagus nerve stimulation in patients with narcolepsy type 1 (TARGET-2): study protocol for a randomised, double-blind, sham-controlled trial
Abstract
Introduction: Narcolepsy type 1 (NT1) is a chronic neurological disorder characterised by excessive daytime sleepiness, cataplexy and disturbed nocturnal sleep. Current pharmacological treatments often have limited efficacy, significant side effects or potential for abuse. Transcutaneous auricular vagus nerve stimulation (taVNS) is a non-invasive neuromodulation technique that has shown promise in regulating sleep-wake cycles and neural network activity. Preliminary evidence from our prior study on Transcutaneous Auricular Vagus Nerve Stimulation in patients with NT1 (TARGET-NT1 study) suggests potential benefits of taVNS for NT1. The TARGET-2 trial aims to evaluate the efficacy and safety of bilateral taVNS compared with unilateral taVNS and sham stimulation in patients with NT1.
Methods and analysis: TARGET-2 is a randomised double-blind trial. A total of 153 participants with NT1 will be recruited from four centres in China. Participants will be randomly allocated (1:1:1) to receive either (1) bilateral taVNS (active stimulation on both ears), (2) unilateral taVNS (active stimulation on the left ear only) or (3) sham taVNS (minimal intensity stimulation on both ears). Participants and outcome assessors are blinded. The intervention will be administered twice daily for 30 min per session over 12 weeks. The primary outcome is the change in the Epworth Sleepiness Scale (ESS) score from baseline to the 12-week endpoint. Secondary outcomes are changes in the narcolepsy…
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: 153 participants or records.
Read the paper
Related studies
- The Matrisome: In Silico Definition and In Vivo Characterization by Proteomics of Normal and Tumor Extracellular Matrices
- The Escherichia coli MG1655 in silico metabolic genotype: Its definition, characteristics, and capabilities
- In silico pharmacology for drug discovery: methods for virtual ligand screening and profiling
- In silico prediction of splice-altering single nucleotide variants in the human genome
- In silico clinical trials: how computer simulation will transform the biomedical industry
- In silico optimization of a guava antimicrobial peptide enables combinatorial exploration for peptide design
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.