An interventional study of transcutaneous auricular vagus nerve stimulation and sham stimulation in Mild Cognitive Impairment (MCI), Parkinsons Disease (PD) and Healthy Adult, sponsored by University of Colorado, Denver. Recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-20.
Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Treatment
This study plans to learn more about how stimulating the vagus nerve through gentle electrical stimulation applied to the ear can affect decision-making, problem-solving, and other thinking abilities. This process, called transcutaneous auricular vagus nerve stimulation (taVNS), could help improve brain function in both healthy individuals and people with Parkinson's disease (PD).
This is a single-site pilot study to assess the safety, feasibility, and potential therapeutic effect of paired-taVNS cognitive training in healthy individuals and people with PD. In the longitudinal study, healthy and PD participants will be prospectively assigned to receive either the sham or active intervention based on order of enrollment in the study. In the acute study, healthy participants will receive both the sham and active intervention, where the order will be prospectively randomized based on order of enrollment in the study.
3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.
This study's planned enrollment of 80 is above the median of 65 across 2,808 interventional studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 315 are open to participants now.
Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.
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Exclusion Criteria:
(6) Other significant diseases or disorders that might impair study participation.
Healthy participants in this arm will receive active transcutaneous auricular vagus nerve stimulation
Device: transcutaneous auricular vagus nerve stimulation
Participants in this arm will receive sham stimulation that does not target the vagus nerve
Device: sham stimulation
Participants with PD in this arm will receive active transcutaneous auricular vagus nerve stimulation
Device: transcutaneous auricular vagus nerve stimulation
Participants with PD in this arm will receive sham stimulation that does not target the vagus nerve
Device: sham stimulation
Electrical stimulation targeting the auricular branch of the vagus nerve
Also known as: taVNS
Sham stimulation of the outer ear that does not target the vagus nerve
Lack of adverse events (AEs) and serious adverse events (SAEs)
a lack of AEs and SAEs during the paired-taVNS intervention
Time frame: From enrollment to the end of treatment at 6 months
Cognitive Task Performance
Accuracy on Stroop Color-Word Task
Time frame: From enrollment to the end of treatment at 6 months
Executive Function network modulation
Measured via MEG to assess changes in functional connectivity and network dynamics in cortical regions implicated in EF.
Time frame: From enrollment to the end of treatment at 6 months
Subjective experience
Patient reported response to perception of stimulation using a 10-point Likert scale where 0 is no sensation and 10 is painful
Time frame: From enrollment to the end of treatment at 6 months
Physiological biomarkers of taVNS
We will look at the relative (%) change in pupil diameter in response to taVNS
Time frame: From enrollment to the end of treatment at 6 months
Plan to share: Undecided
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University of Colorado, Denver