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

NCT07424365 | Recruiting FDA Device

• 1 other identifier: 24-2546
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Mild Cognitive Impairment (MCI); Parkinsons Disease (PD); Healthy Adult

Outcome Measures

Primary Outcomes (1)

• Lack of adverse events (AEs) and serious adverse events (SAEs)

  a lack of AEs and SAEs during the paired-taVNS intervention

  From enrollment to the end of treatment at 6 months

Secondary Outcomes (3)

• Cognitive Task Performance

  From enrollment to the end of treatment at 6 months

• Executive Function network modulation

  From enrollment to the end of treatment at 6 months

• Subjective experience

  From enrollment to the end of treatment at 6 months

Other Outcomes (1)

• Physiological biomarkers of taVNS

  From enrollment to the end of treatment at 6 months

Study Arms (4)

active stimulation (healthy controls)

EXPERIMENTAL

Healthy participants in this arm will receive active transcutaneous auricular vagus nerve stimulation

Device: transcutaneous auricular vagus nerve stimulation

sham stimulation (healthy controls)

SHAM COMPARATOR

Participants in this arm will receive sham stimulation that does not target the vagus nerve

Device: sham stimulation

active stimulation (Patients with Parkinson's Disease)

EXPERIMENTAL

Participants with PD in this arm will receive active transcutaneous auricular vagus nerve stimulation

Device: transcutaneous auricular vagus nerve stimulation

sham stimulation (patients with Parkinson's Disease)

SHAM COMPARATOR

Participants with PD in this arm will receive sham stimulation that does not target the vagus nerve

Device: sham stimulation

Interventions

sham stimulation DEVICE

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

sham stimulation (healthy controls); sham stimulation (patients with Parkinson's Disease)

transcutaneous auricular vagus nerve stimulation DEVICE

Electrical stimulation targeting the auricular branch of the vagus nerve

Also known as: taVNS

active stimulation (Patients with Parkinson's Disease); active stimulation (healthy controls)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Clinical Translational Research Center at CU Anschutz

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction; Parkinson Disease

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Cristin Welle, PhD

  Dept. of Neurosurgery, School of Medicine, University of Colorado Anschutz Medical Campus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elise R Carter

CONTACT

3094335932; elise.carter@cuanschutz.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: February 20, 2026
• Study Start: May 19, 2025
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: February 20, 2026

Record last verified: 2026-02

Locations

US (1)