Clinical Translational Research Center at CU Anschutz
Aurora, Colorado, 80045, United States
Location status: Recruiting
NCT Number: NCT07424365
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).
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
Aurora, Colorado, 80045, United States
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
(6) Other significant diseases or disorders that might impair study participation.
Electrical stimulation targeting the auricular branch of the vagus nerve
Other names: taVNS
Sham stimulation of the outer ear that does not target the vagus nerve
Time frame: From enrollment to the end of treatment at 6 months
a lack of AEs and SAEs during the paired-taVNS intervention
Time frame: From enrollment to the end of treatment at 6 months
Accuracy on Stroop Color-Word Task
Time frame: From enrollment to the end of treatment at 6 months
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
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
We will look at the relative (%) change in pupil diameter in response to taVNS
Interested in participating?
Request InfoUniversity of Colorado, Denver
Other
Investigation of Vagus Nerve Stimulation to Augment Executive Functioning
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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