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NCT07424365 | RECRUITING | Mild Cognitive Impairment (MCI)

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

University of Colorado, Denver

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).

Condition or disease

Mild Cognitive Impairment (MCI)

Parkinsons Disease (PD)

Healthy Adult

Intervention/treatment

transcutaneous auricular vagus nerve stimulation

sham stimulation

Phase

NA

Detailed Description:

This is a single-site pilot study to assess the safety, feasibility, and potential therapeutic effect of paired-taVNS cognitive training in healthy individuals and people with PD. In the longitudinal study, healthy and PD participants will be prospectively assigned to receive either the sham or active intervention based on order of enrollment in the study. In the acute study, healthy participants will receive both the sham and active intervention, where the order will be prospectively randomized based on order of enrollment in the study.

Study Type : INTERVENTIONAL
Estimated Enrollment : 80 participants
Masking : SINGLE
Primary Purpose : TREATMENT
Official Title : Investigation of Vagus Nerve Stimulation to Augment Executive Functioning
Actual Study Start Date : 2025-05-19
Estimated Primary Completion Date : 2028-05
Estimated Study Completion Date : 2028-05

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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.
Study to Investigate Vagus Nerve Stimulation to Augment Executive Function in Healthy and Cognitively Impaired Populations

Location Details

NCT07424365

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Colorado

Clinical Translational Research Center at CU Anschutz

Aurora, Colorado, United States, 80045