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NCT Number: NCT07424365

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

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).

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Translational Research Center at CU Anschutz

Aurora, Colorado, 80045, United States

Location status: Recruiting

Location contact

Colorado Clinical and Translational Sciences Institute

CONTACT

[email protected]

303-724-1222

Cristin Welle, PhD

PRINCIPAL_INVESTIGATOR

Daniel Kramer, MD

SUB_INVESTIGATOR

Isabelle Buard, PhD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

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

Treatment and study plan

Transcutaneous Auricular Vagus Nerve Stimulation

Device

Electrical stimulation targeting the auricular branch of the vagus nerve

Other names: taVNS

Sham stimulation

Device

Sham stimulation of the outer ear that does not target the vagus nerve

Primary outcomes

  1. 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

Secondary outcomes

  1. Cognitive Task Performance

    Time frame: From enrollment to the end of treatment at 6 months

    Accuracy on Stroop Color-Word Task

  2. 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.

  3. 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

Other outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Elise R Carter

CONTACT

[email protected]

3094335932

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

Investigation of Vagus Nerve Stimulation to Augment Executive Functioning

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Feb 20, 2026
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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