Healthy Adult, Mild Cognitive Impairment (MCI), Parkinsons Disease (PD)
Conditions
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).
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
DEVICEtranscutaneous auricular vagus nerve stimulation
Electrical stimulation targeting the auricular branch of the vagus nerve
DEVICEsham stimulation
Sham stimulation of the outer ear that does not target the vagus nerve
Sponsors
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lack of adverse events (AEs) and serious adverse events (SAEs) | From enrollment to the end of treatment at 6 months | a lack of AEs and SAEs during the paired-taVNS intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive Task Performance | From enrollment to the end of treatment at 6 months | Accuracy on Stroop Color-Word Task |
| Executive Function network modulation | From enrollment to the end of treatment at 6 months | Measured via MEG to assess changes in functional connectivity and network dynamics in cortical regions implicated in EF. |
| Subjective experience | From enrollment to the end of treatment at 6 months | Patient reported response to perception of stimulation using a 10-point Likert scale where 0 is no sensation and 10 is painful |
Countries
United States
Contacts
CONTACTElise R Carter
PRINCIPAL_INVESTIGATORCristin Welle, PhD
Dept. of Neurosurgery, School of Medicine, University of Colorado Anschutz Medical Campus
Outcome results
None listed