Recruiting

taVNS

Sponsor:

University of Colorado, Denver

Code:

NCT07424365

Conditions

Mild Cognitive Impairment (MCI)

Parkinsons Disease (PD)

Healthy Adult

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

transcutaneous auricular vagus nerve stimulation

sham stimulation

Study Details

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

Study ID

NCT07424365

Start date

May 19, 2025

Status verified date

Feb, 2026

Completion date

May, 2028

Anticipated

Primary completion date

May, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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 Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: active stimulation (healthy controls)

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

sham comparator: sham stimulation (healthy controls)

Participants in this arm will receive sham stimulation 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

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

Interventions

transcutaneous auricular vagus nerve stimulation

Electrical stimulation targeting the auricular branch of the vagus nerve

sham stimulation

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

Primary outcome measure

  • Lack of adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: From enrollment to the end of treatment at 6 months ]

Central Contacts and Locations

Central contacts

Elise R Carter

3094335932elise.carter@cuanschutz.edu

Locations

Clinical Translational Research Center at CU Anschutz

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Colorado Clinical and Translational Sciences Institute

303-724-1222CCTSI.Helpdesk@ucdenver.edu

Principal Investigator:

Cristin Welle, PhD

More Information

Sponsor

University of Colorado, Denver

Last update posted

Feb 20, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2026-02-20.