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

University of Colorado, Denver80 enrolled

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).

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Lack of adverse events (AEs) and serious adverse events (SAEs)

a lack of AEs and SAEs during the paired-taVNS intervention

Time frame: From enrollment to the end of treatment at 6 months

Secondary Outcomes

Cognitive Task Performance

Accuracy on Stroop Color-Word Task

Time frame: From enrollment to the end of treatment at 6 months

Executive Function network modulation

Measured via MEG to assess changes in functional connectivity and network dynamics in cortical regions implicated in EF.

Time frame: From enrollment to the end of treatment at 6 months

Subjective experience

Patient reported response to perception of stimulation using a 10-point Likert scale where 0 is no sensation and 10 is painful

Time frame: From enrollment to the end of treatment at 6 months

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts