Study to Investigate Vagus Nerve Stimulation to Augment Executive Function in Healthy and Cognitively Impaired Populations
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: transcutaneous auricular vagus nerve stimulation, sham stimulation.
- Who it may be relevant to
- Registry conditions: Mild Cognitive Impairment (MCI), Parkinsons Disease (PD), Healthy Adult. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Investigation of Vagus Nerve Stimulation to Augment Executive Functioning
Overview
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).
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.
Interventions
- Device transcutaneous auricular vagus nerve stimulation
Electrical stimulation targeting the auricular branch of the vagus nerve - Device sham stimulation
Sham stimulation of the outer ear that does not target the vagus nerve
Primary outcome measures
- Lack of adverse events (AEs) and serious adverse events (SAEs) [Time frame: From enrollment to the end of treatment at 6 months]
Secondary outcome measures (3)
- Cognitive Task Performance [Time frame: From enrollment to the end of treatment at 6 months]
- Executive Function network modulation [Time frame: From enrollment to the end of treatment at 6 months]
- Subjective experience [Time frame: From enrollment to the end of treatment at 6 months]
Eligibility criteria
Inclusion criteria
- Individuals aged 18-65.
- Ability to sign informed consent.
- Ability to follow written and verbal instructions.
- For the PD group, a clinical diagnosis of Parkinson's disease without severe motor or cognitive impairments.
Exclusion criteria
- Current uncontrolled and/or clinically significant medical condition.
- Abnormal ear anatomy or active ear infection.
- Electronic medical implants, such as pacemakers, cochlear prosthesis, neuro-stimulators.
- Uncorrected visual impairments that would interfere with task performance.
(6) Other significant diseases or disorders that might impair study participation.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Clinical Translational Research Center at CU Anschutz — Aurora
Identifiers
NCT: NCT07424365 · 24-2546