Mild Cognitive Impairment (MCI)NCT07424365
Study to Investigate Vagus Nerve Stimulation to Augment Executive Function in Healthy and Cognitively Impaired Populations
A study testing transcutaneous auricular vagus nerve stimulation in people with Mild Cognitive Impairment (MCI) and Parkinsons Disease (PD), run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment (MCI), Parkinsons Disease (PD), Healthy Adult
- What is being tested?
- transcutaneous auricular vagus nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 19 May 2025to May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- Other significant diseases or disorders that might impair study participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Clinical Translational Research Center at CU Anschutz
Aurora, Colorado, 80045
Colorado Clinical and Translational Sciences Institute, 303-724-1222, CCTSI.Helpdesk@ucdenver.edu
Cristin Welle, PhD
About this study
Official title: Investigation of Vagus Nerve Stimulation to Augment Executive Functioning
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).
Read the 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.
- Being tested
- transcutaneous auricular vagus nerve stimulation, sham stimulation
- Medical subject headings
- Cognitive Dysfunction, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous auricular vagus nerve stimulationDevice
Also called taVNS
Electrical stimulation targeting the auricular branch of the vagus nerve
sham stimulationDevice
Sham stimulation of the outer ear that does not target the vagus nerve
| Study group | Role | What they receive |
|---|---|---|
| active stimulation (healthy controls) | Experimental | Healthy participants in this arm will receive active transcutaneous auricular vagus nerve stimulation Receives: Device: transcutaneous auricular vagus nerve stimulation |
| sham stimulation (healthy controls) | Sham comparator | Participants in this arm will receive sham stimulation that does not target the vagus nerve Receives: Device: sham stimulation |
| active stimulation (Patients with Parkinson's Disease) | Experimental | Participants with PD in this arm will receive active transcutaneous auricular vagus nerve stimulation Receives: Device: transcutaneous auricular vagus nerve stimulation |
| sham stimulation (patients with Parkinson's Disease) | Sham comparator | Participants with PD in this arm will receive sham stimulation that does not target the vagus nerve Receives: Device: sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lack of adverse events (AEs) and serious adverse events (SAEs)
a lack of AEs and SAEs during the paired-taVNS intervention
Measured: From enrollment to the end of treatment at 6 months
Secondary outcomes (3)
Cognitive Task Performance
Accuracy on Stroop Color-Word Task
Measured: 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.
Measured: 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
Measured: From enrollment to the end of treatment at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start19 May 2025
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive Impairment (MCI)Studies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cristin Welle, PhD, Principal investigator, Dept. of Neurosurgery, School of Medicine, University of Colorado Anschutz Medical Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07424365
- Sponsor's protocol ID
- 24-2546
- Status last verified
- Feb 2026
- First submitted
- 5 Feb 2026
- Last updated
- 20 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Vagus Nerve Stimulation to Augment Executive Functioning
- ClinicalTrials.gov ID
- NCT07424365
- Acronym / sponsor ID
- 24-2546
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 19 May 2025 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 20 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| active stimulation (healthy controls) | Experimental | Device: transcutaneous auricular vagus nerve stimulationHealthy participants in this arm will receive active transcutaneous auricular vagus nerve stimulation |
| sham stimulation (healthy controls) | Sham comparator | Device: sham stimulationParticipants in this arm will receive sham stimulation that does not target the vagus nerve |
| active stimulation (Patients with Parkinson's Disease) | Experimental | Device: transcutaneous auricular vagus nerve stimulationParticipants with PD in this arm will receive active transcutaneous auricular vagus nerve stimulation |
| sham stimulation (patients with Parkinson's Disease) | Sham comparator | Device: sham stimulationParticipants with PD in this arm will receive sham stimulation that does not target the vagus nerve |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
- Other significant diseases or disorders that might impair study participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcutaneous auricular vagus nerve stimulationAlso: taVNSElectrical stimulation targeting the auricular branch of the vagus nerve | Device | active stimulation (Patients with Parkinson's Disease), active stimulation (healthy controls) |
| sham stimulationSham stimulation of the outer ear that does not target the vagus nerve | Device | sham stimulation (healthy controls), sham stimulation (patients with Parkinson's Disease) |
Primary outcome
Lack of adverse events (AEs) and serious adverse events (SAEs)
Time frame: From enrollment to the end of treatment at 6 months
a lack of AEs and SAEs during the paired-taVNS intervention
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cristin Welle, PhD principal investigator
Dept. of Neurosurgery, School of Medicine, University of Colorado Anschutz Medical Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcutaneous auricular vagus nerve stimulation in people with Mild Cognitive Impairment (MCI) and Parkinsons Disease (PD), run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elise R Carter (3094335932, elise.carter@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.