Related Experiment Video
Updated: Jul 20, 2025
Laboratory Administration of Transcutaneous Auricular Vagus Nerve Stimulation taVNS: Technique, Targeting, and Considerations
Published on: January 7, 2019
Safety and feasibility of transcutaneous vagus nerve stimulation in mild cognitive impairment: VINCI-AD study
Helena Dolphin1,2,3, Adam H Dyer4,5, Tim Dukelow6
1Department of Medical Gerontology, Trinity College, Dublin 2, Dublin, Ireland. dolphinh@tcd.ie.
Background:
Over 55 million adults are living with dementia globally, which is projected to reach 157 million by 2050. Mild cognitive impairment (MCI), a syndrome of memory impairment with intact activities of daily living, may precede dementia by several years. Around 5-15% of individuals with MCI convert to dementia annually. Novel treatments which delay progression of MCI to dementia are urgently needed. Transcutaneous vagal nerve stimulation (tVNS) is a non-invasive neuromodulation technique that targets the vagus nerve. Importantly, tVNS has been shown to improve cognition in healthy volunteers, but has not been extensively examined as a potential therapeutic approach in MCI. VINCI-AD will examine the safety and feasibility of tVNS in older adults with MCI.
Design:
VINCI-AD is an investigator-led, single-site, single-blind, sham-controlled crossover pilot study which aims to assess the safety and feasibility of tVNS in 40 participants with amnestic MCI. All participants will attend for three consecutive study visits during which they will be randomised to receive no stimulation (baseline), active tVNS stimulation (stimulation at cymba conchae of left ear) or sham tVNS stimulation (at earlobe). Safety will be primarily assessed by ascertainment of adverse events. Further safety assessment will examine the impact of acute tVNS on subjective (orthostatic symptoms), peripheral (finometry-based blood pressure) and central (assessed via Near Infrared Spectroscopy [NIRS]) haemodynamic responses to active stand. Feasibility will be determined using a custom-designed occupational assessment of device usability. Exploratory secondary analysis in VINCI-AD will examine the potential impact of acute tVNS on associative memory, spatial memory and inhibitory control to inform sample size estimates for future trials of tVNS in older adults with MCI.
Discussion:
VINCI-AD will report on the safety (adverse events/haemodynamic responses to active stand) and feasibility of tVNS as a potential therapeutic option in MCI. Detailed reporting of study eligibility and completion rates will be reported. Exploratory analysis will examine the potential cognitive benefits of acute tVNS on cognitive function in MCI to report potential effect sizes that may inform future clinical trials in this cohort.
Trial Registration:
https://clinicaltrials.gov/ct2/show/NCT05514756 . Trial Registration Number NCT05514756 (24th August 2022 for this protocol, version 1.0.).
Insights
This pilot study assesses the safety and feasibility of transcutaneous vagal nerve stimulation (tVNS) for mild cognitive impairment (MCI). Results will inform future trials on tVNS as a potential therapeutic for delaying dementia progression.
Area of Science:
- Neuromodulation
- Neuroscience
- Gerontology
Background:
- Dementia affects over 55 million adults globally, with mild cognitive impairment (MCI) often preceding it.
- Approximately 5-15% of individuals with MCI convert to dementia annually, highlighting the need for novel treatments.
- Transcutaneous vagal nerve stimulation (tVNS) is a non-invasive technique showing cognitive benefits in healthy individuals, but its therapeutic potential in MCI requires further investigation.
Purpose of the Study:
- To evaluate the safety and feasibility of tVNS in older adults diagnosed with amnestic mild cognitive impairment (MCI).
- To explore the potential cognitive effects of acute tVNS on memory and executive function in individuals with MCI.
- To gather data for sample size estimations in future clinical trials investigating tVNS for MCI.
Main Methods:
- A single-site, single-blind, sham-controlled crossover pilot study involving 40 participants with amnestic MCI.
- Participants received either active tVNS, sham tVNS, or no stimulation across three study visits.
- Safety assessed via adverse events and hemodynamic responses (orthostatic, peripheral, central) to active stand; feasibility via device usability assessment.
Main Results:
- The study will report on the safety profile of tVNS, including adverse events and hemodynamic changes.
- Feasibility will be determined by assessing device usability and participant adherence.
- Exploratory analyses will examine acute tVNS effects on associative memory, spatial memory, and inhibitory control.
Conclusions:
- The VINCI-AD study will provide crucial data on the safety and feasibility of tVNS for individuals with MCI.
- Findings will elucidate potential cognitive benefits and effect sizes, guiding the design of future clinical trials.
- This research may pave the way for tVNS as a therapeutic intervention to potentially delay MCI progression to dementia.
