Study to Investigate Vagus Nerve Stimulation to Augment Executive Function in Healthy and Cognitively Impaired Populations

February 19, 2026 updated by: University of Colorado, Denver

Investigation of Vagus Nerve Stimulation to Augment Executive Functioning

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • Clinical Translational Research Center at CU Anschutz
        • Sub-Investigator:
          • Daniel Kramer, MD
        • Contact:
        • Principal Investigator:
          • Cristin Welle, PhD
        • Sub-Investigator:
          • Isabelle Buard, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Individuals aged 18-65.
  2. Ability to sign informed consent.
  3. Ability to follow written and verbal instructions.
  4. For the PD group, a clinical diagnosis of Parkinson's disease without severe motor or cognitive impairments.

Exclusion Criteria:

  1. Current uncontrolled and/or clinically significant medical condition.
  2. Abnormal ear anatomy or active ear infection.
  3. Electronic medical implants, such as pacemakers, cochlear prosthesis, neuro-stimulators.
  4. Uncorrected visual impairments that would interfere with task performance.

(6) Other significant diseases or disorders that might impair study participation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: active stimulation (healthy controls)
Healthy participants in this arm will receive active transcutaneous auricular vagus nerve stimulation
Device: transcutaneous auricular vagus nerve stimulation
Electrical stimulation targeting the auricular branch of the vagus nerve
Other Names:
  • taVNS
Sham Comparator: sham stimulation (healthy controls)
Participants in this arm will receive sham stimulation that does not target the vagus nerve
Device: sham stimulation
Sham stimulation of the outer ear that does not target the vagus nerve
Experimental: active stimulation (Patients with Parkinson's Disease)
Participants with PD in this arm will receive active transcutaneous auricular vagus nerve stimulation
Device: transcutaneous auricular vagus nerve stimulation
Electrical stimulation targeting the auricular branch of the vagus nerve
Other Names:
  • taVNS
Sham Comparator: sham stimulation (patients with Parkinson's Disease)
Participants with PD in this arm will receive sham stimulation that does not target the vagus nerve
Device: sham stimulation
Sham stimulation of the outer ear that does not target the vagus nerve

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lack of adverse events (AEs) and serious adverse events (SAEs)
Time Frame: From enrollment to the end of treatment at 6 months
a lack of AEs and SAEs during the paired-taVNS intervention
From enrollment to the end of treatment at 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive Task Performance
Time Frame: From enrollment to the end of treatment at 6 months
Accuracy on Stroop Color-Word Task
From enrollment to the end of treatment at 6 months
Executive Function network modulation
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.
From enrollment to the end of treatment at 6 months
Subjective experience
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
From enrollment to the end of treatment at 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physiological biomarkers of taVNS
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
From enrollment to the end of treatment at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Investigators

  • Principal Investigator: Cristin Welle, PhD, Dept. of Neurosurgery, School of Medicine, University of Colorado Anschutz Medical Campus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 19, 2025

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2028

Study Registration Dates

First Submitted

February 5, 2026

First Submitted That Met QC Criteria

February 19, 2026

First Posted (Actual)

February 20, 2026

Study Record Updates

Last Update Posted (Actual)

February 20, 2026

Last Update Submitted That Met QC Criteria

February 19, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-2546

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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