Alzheimer DiseaseVNSNCT07214194
Vagus Nerve Stimulation to Enhance Memory in Aging
A study testing Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) in people with Alzheimer Disease and Aging, run by Stanford University at 1 site in United States.
Trial summary
The aim of this study is to determine whether non-invasive vagus nerve stimulation enhances memory formation in cognitively healthy older adults and whether the effects of stimulation depend on gut and brain health. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Aging
- What is being tested?
- Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2027to Jul 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ages 18-30 years or 65-80 years
- Normal or corrected-to-normal vision (visual acuity)
- Fluent in English
Who cannot join
- Pregnant
- Symptoms of memory loss
- History of a neurological, psychiatric, or medical condition that could affect cognition or preclude MRI or pupillometry
- Use of medications known to alter cognition
- For older adults, neuropsychological performance that falls outside 1.5 standard deviations of age-adjusted norms and no self-reported memory or attention complaints
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The aim of this study is to determine whether non-invasive vagus nerve stimulation enhances memory formation in cognitively healthy older adults and whether the effects of stimulation depend on gut and brain health.
- Conditions
- Alzheimer Disease, Aging
- Being tested
- Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)Device
Non-invasive vagus nerve stimulation will be delivered with a well-validated device. taVNS delivers stimulation on the left ear, with the placement of the stimulating electrode differing between the active and sham conditions. Stimulation will occur during each learning trial (total of 30 trials per phase).
| Study group | Role | What they receive |
|---|---|---|
| Active vagus nerve stimulation | Experimental | Participants will receive active stimulation during memory encoding of picture-word pairs. Active stimulation will occur during two learning phases of the learning and memory task. The total duration of these two phases will be less than 30 minutes. Receives: Device: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) |
| Sham stimulation | Sham comparator | Participants will receive sham stimulation during memory encoding of picture-word pairs. Sham stimulation will occur during two learning phases of the learning and memory task. The total duration of these two phases will be less than 30 minutes. Receives: Device: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Recognition Memory (d-prime)
d' is a signal-detection sensitivity index-how well participants discriminate old (studied) from new (unstudied) items, independent of response bias. Computed as d' = Z(hit rate) - Z(false-alarm rate) from the old/new recognition memory test. Primary analysis is within-person Δhigh-confidence d' (based on "sure old" responses in the 4-point "sure old", "unsure old", "unsure new", "sure new" scale, Δ = active - sham) and Δoverall d' (based on "sure old" and "unsure old" responses). Main comparison is older vs. young, and within the older group also testing moderation by gut-brain axis measures and interactions with preclinical Alzheimer's disease pathology (pTau217, pTau181, Aβ42:40).
Measured: post-active vs post-sham stimulation; up to 2 hours of task
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2025
- Study startFeb 2027 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The study will use a sham-controlled, single-blind, within-subject, counterbalanced, randomized design. Each participant will complete four blocks (two active and two sham stimulation) in a counterbalanced within-subject design using an ABBA or BAAB order (A = active taVNS, B = sham stimulation). To ensure equal numbers per order, order will be deterministically assigned by subject ID parity: odd = ABBA, even = BAAB. Subject IDs will be issued sequentially within the age group, yielding balance in both Young and Older groups and effective random assignment of participants to order condition.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Anthony David Wagner, Stanford University
- Investigators
- Anthony D Wagner, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07214194
- Sponsor's protocol ID
- VNS102025
- Acronym
- VNS
- Status last verified
- Oct 2025
- First submitted
- 2 Oct 2025
- Last updated
- 9 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All other data will be made available via Stanford's Digital Repository (SDR) and will be linked with associated analytic code on the Stanford Memory Lab's Github. Additionally, the task and analysis scripts, along with comments explaining the source code and instructions to install and configure software required to run the scripts, will be shared via the website of the Stanford Memory Lab and our repository on GitHub. SDR is accessible to investigators who are not affiliated with Stanford University and does not require data to be associated with a publication prior to being accepted by the repository. This data archiving approach ensures that the broader scientific community will have long-term access to all data and analysis code.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vagus Nerve Stimulation to Enhance Memory in Aging
- ClinicalTrials.gov ID
- NCT07214194
- Acronym / sponsor ID
- VNS / VNS102025
- Conditions
- Alzheimer Disease, Aging
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Feb 2027 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 9 Oct 2025 (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.
The aim of this study is to determine whether non-invasive vagus nerve stimulation enhances memory formation in cognitively healthy older adults and whether the effects of stimulation depend on gut and brain health.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study will use a sham-controlled, single-blind, within-subject, counterbalanced, randomized design. Each participant will complete four blocks (two active and two sham stimulation) in a counterbalanced within-subject design using an ABBA or BAAB order (A = active taVNS, B = sham stimulation). To ensure equal numbers per order, order will be deterministically assigned by subject ID parity: odd = ABBA, even = BAAB. Subject IDs will be issued sequentially within the age group, yielding balance in both Young and Older groups and effective random assignment of participants to order condition.
| Arm | Type | Receives |
|---|---|---|
| Active vagus nerve stimulation | Experimental | Device: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)Participants will receive active stimulation during memory encoding of picture-word pairs. Active stimulation will occur during two learning phases of the learning and memory task. The total duration of these two phases will be less than 30 minutes. |
| Sham stimulation | Sham comparator | Device: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)Participants will receive sham stimulation during memory encoding of picture-word pairs. Sham stimulation will occur during two learning phases of the learning and memory task. The total duration of these two phases will be less than 30 minutes. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ages 18-30 years or 65-80 years
- Normal or corrected-to-normal vision (visual acuity)
- Fluent in English
Key exclusion criteria (5 listed)
- Pregnant
- Symptoms of memory loss
- History of a neurological, psychiatric, or medical condition that could affect cognition or preclude MRI or pupillometry
- Use of medications known to alter cognition
- For older adults, neuropsychological performance that falls outside 1.5 standard deviations of age-adjusted norms and no self-reported memory or attention complaints
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 Stimulation (taVNS)Non-invasive vagus nerve stimulation will be delivered with a well-validated device. taVNS delivers stimulation on the left ear, with the placement of the stimulating electrode differing between the active and sham conditions. Stimulation will occur during each learning trial (total of 30 trials per phase). | Device | Active vagus nerve stimulation, Sham stimulation |
Primary outcome
Change in Recognition Memory (d-prime)
Time frame: post-active vs post-sham stimulation; up to 2 hours of task
d' is a signal-detection sensitivity index-how well participants discriminate old (studied) from new (unstudied) items, independent of response bias. Computed as d' = Z(hit rate) - Z(false-alarm rate) from the old/new recognition memory test. Primary analysis is within-person Δhigh-confidence d' (based on "sure old" responses in the 4-point "sure old", "unsure old", "unsure new", "sure new" scale, Δ = active - sham) and Δoverall d' (based on "sure old" and "unsure old" responses). Main comparison is older vs. young, and within the older group also testing moderation by gut-brain axis measures and interactions with preclinical Alzheimer's disease pathology (pTau217, pTau181, Aβ42:40).
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 9 Oct 2025.
- Individual participant dataSharing planned: Yes. All other data will be made available via Stanford's Digital Repository (SDR) and will be linked with associated analytic code on the Stanford Memory Lab's Github. Additionally, the task and analysis scripts, along with comments explaining the source code and instructions to install and configure software required to run the scripts, will be shared via the website of the Stanford Memory Lab and our repository on GitHub. SDR is accessible to investigators who are not affiliated with Stanford University and does not require data to be associated with a publication prior to being accepted by the repository. This data archiving approach ensures that the broader scientific community will have long-term access to all data and analysis code.
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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.
Anthony D Wagner, PhD principal investigator
Stanford University
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 (taVNS) in people with Alzheimer Disease and Aging, run by Stanford University 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 3 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: opening soon, as of the sponsor's last update on 9 Oct 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Recognition Memory (d-prime) (time frame: post-active vs post-sham stimulation; up to 2 hours of task). 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 9 Oct 2025.