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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT07424365
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • transcutaneous auricular vagus nerve stimulation — DEVICE
    Electrical stimulation targeting the auricular branch of the vagus nerve
  • sham stimulation — DEVICE
    Sham stimulation of the outer ear that does not target the vagus nerve

Study Details

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).

Key Dates

Start date
May 19, 2025
Status verified
Feb 2026
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

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

Locations (1)

FacilityCityStateZIPSite coordinators
Clinical Translational Research Center at CU AnschutzAuroraColorado80045
Colorado Clinical and Translational Sciences Institute
[email protected]
303-724-1222
Cristin Welle, PhD (PRINCIPAL_INVESTIGATOR)
Isabelle Buard, PhD (SUB_INVESTIGATOR)
Daniel Kramer, MD (SUB_INVESTIGATOR)

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By research site
Clinical Translational Research Center at CU Anschutz· Aurora, CO

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