Ear-based vagus nerve stimulation to boost decision-making and other thinking skills in people with Parkinson's and healthy adults

Investigation of Vagus Nerve Stimulation to Augment Executive Functioning

This project will try gentle electrical stimulation of the ear (taVNS) to see if it improves decision-making and other thinking skills in people with Parkinson's disease and in healthy adults.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: University of Colorado, Denver (Academic / other)
• Locations: 1 site (Aurora, Colorado)
• Trial ID: NCT07424365 on ClinicalTrials.gov

What this trial studies

This single-site pilot pairs noninvasive transcutaneous auricular vagus nerve stimulation (taVNS) with cognitive training to test safety, feasibility, and potential cognitive benefits in healthy adults and people with Parkinson's disease. The study includes a longitudinal component in which participants are prospectively assigned to active or sham stimulation based on enrollment order, and an acute component in healthy participants who receive both sham and active stimulation in randomized order. Outcome measures focus on executive function tasks such as decision-making and problem-solving, along with safety and tolerability monitoring. The goal is to gather preliminary data to inform larger controlled trials.

Who should consider this trial

Good fit: Adults aged 18–65 who can give informed consent and follow instructions, including healthy volunteers and people with Parkinson's disease who do not have severe motor or cognitive impairments.

Not a fit: People with implanted electronic medical devices (e.g., pacemakers, cochlear implants, neurostimulators), abnormal or infected ears, uncontrolled medical conditions, uncorrected visual impairments, or severe motor/cognitive impairment may not be eligible or likely to benefit.

Why it matters

Potential benefit: If successful, taVNS paired with cognitive training could improve executive functions like decision-making and problem-solving and offer a noninvasive therapy option for people with PD and others with cognitive concerns.

How similar studies have performed: Small prior studies have shown that taVNS can alter attention and memory measures in some participants, but evidence for lasting cognitive improvement—especially in Parkinson's disease—is preliminary and mixed.

Eligibility criteria

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.

Where this trial is running

Aurora, Colorado

• Clinical Translational Research Center at CU Anschutz — Aurora, Colorado, United States (Recruiting)

Study contacts

• Principal investigator: Cristin Welle, PhD — Dept. of Neurosurgery, School of Medicine, University of Colorado Anschutz Medical Campus
• Study coordinator: Elise R Carter

Conditions Mild Cognitive Impairment; Parkinsons Disease; Healthy Adult