Study design
amnestic MCI
ADVERSE EVENT, HEART, ADVERSE EVENT
VINCI-AD is a single-site, single-blind, sham-controlled crossover pilot study in patients with amnestic MCI. Each participant is assessed at baseline (no stimulation) followed by randomisation to both sham stimulation and active tVNS stimulation over two subsequent study visits. The study comprises a baseline assessment (visit 1) followed 7–10 days later by either an active or sham stimulation study visit and again 7–10 days later by a third visit wherein the final condition (active or sham) will be undertaken. The inclusion of a sham stimulation condition is to confound for potential unblinding, which is common in device trials. Participants will be enrolled and consented by study clinician (HD). Please see Fig. 
Method of crossoverOur study will follow the Standard Protocol Items: recommendations for Interventional Trials (SPIRIT) guidelines [
Flowchart of VINCI-AD Protocol TimelineØ = active stimulation randomisation: participant randomised to either sham or active stimulation at Visit 2 and alternative stimulation site at Visit 3† = sham stimulation randomisation: participant randomised to either sham or active stimulation at Visit 2 and alternative stimulation site at Visit 3AE – Adverse event; SAE – Serious adverse event; FNAT – Face Name Association Task; SART – Sustained Attention Response Task; SHQ – Sea Hero Quest Tas; NIRS – functional Near Infrared Spectroscopy; HRV – Heart Rate Variability; TSI – Tissue Saturation Index