Actively Recruiting
Investigation of Vagus Nerve Stimulation to Augment Executive Functioning
Led by University of Colorado, Denver · Updated on 2026-02-20
80
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how gentle electrical stimulation of the vagus nerve through the ear, called transcutaneous auricular vagus nerve stimulation (taVNS), might affect thinking abilities like decision-making and problem-solving. This study includes both healthy adults and people with Parkinson's disease to explore whether this method could help improve brain function. The research is a pilot study focused on safety, feasibility, and potential therapy effects. Participants will be assigned to receive either active taVNS or a sham stimulation that does not target the vagus nerve. Healthy participants in the acute study will receive both types in a randomized order, while others will be assigned based on enrollment order. The stimulation is applied to the ear using a device, and the study groups include healthy controls and individuals with Parkinson's disease. During the study, researchers will monitor participants for any adverse events and evaluate cognitive task performance, modulation of executive function networks, and participants' subjective experiences over a 6-month treatment period. Participants will be assessed through cognitive tests and safety monitoring to understand the impact of the stimulation on brain function. The study will last from enrollment to 6 months, with ongoing evaluation throughout this time.
CONDITIONS
Brief Title
Study to Investigate Vagus Nerve Stimulation to Augment Executive Function in Healthy and Cognitively Impaired Populations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individuals aged 18 to 65 years
- Ability to sign informed consent
- Ability to follow written and verbal instructions
- For Parkinson's disease group, clinical diagnosis without severe motor or cognitive impairments
You will not qualify if you...
- Current uncontrolled and/or clinically significant medical condition
- Abnormal ear anatomy or active ear infection
- Presence of electronic medical implants like pacemakers or cochlear prosthesis
- Uncorrected visual impairments that interfere with task performance
- Other significant diseases or disorders that might impair participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 6 months
Participants receive either active or sham transcutaneous auricular vagus nerve stimulation to evaluate safety and potential cognitive benefits.
Trial Site Locations
Total: 1 location
1
Clinical Translational Research Center at CU Anschutz
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
E
Elise R Carter
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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