Cognitive PerformanceNCT04484285

Home Operations Utilizing Stimulation

A study testing Transcutaneous Vagal Nerve Stimulation (tVNS) in people with Cognitive Performance, run by University of Florida at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This project will utilize a home-operated stimulator in 1) a healthy young adult population and 2) a healthy older adult population to provide a proof of concept of home-use of transcutaneous vagal nerve stimulation (tVNS). tVNS is believed to modulate cognitive performance. Read more about this study

Who is it for?: Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for: Cognitive Performance
What is being tested?: Transcutaneous Vagal Nerve Stimulation (tVNS)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteUnited States
Study dates: 20 Aug 2020to 6 Sep 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 85 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Participants for one cohort will be adults between the ages of 18-55, consistent with the typical college population
Participants for the other cohort will be adults between the ages of 56 - 85. Participants must read and write English.

Who cannot join

Major medical illnesses including diagnosed severe neurological illnesses (e.g., stroke, seizure history), autoimmune disorders, and severe psychiatric diseases (e.g., schizophrenia) will be excluded. Participants with any history of brain surgery, tumor, intracranial metal implantation, pacemakers or other implanted devices will be excluded.
Sleep medications and/or psychostimulants are exclusionary. Subjects in the older cohort will NOT be excluded for taking blood pressure and cholesterol medication. Participants who are pregnant will be excluded. If participants have a history of adverse reaction to electrical nerve stimulation, they will be excluded.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Florida McKnight Brain Institute
Gainesville, Florida, 32643

Other trials in United States

About this study

Read the detailed description

The vagal nerve is a major component of the autonomic nervous system and mediates the physiological responses of major organs during moments of stress and learning, including brain areas that modulate cognitive performance. Vagal nerve stimulation (VNS) has been indicated to improve stress response and to enhance neuroplasticity by directly impacting brain structures critical for cognition. Historically, VNS methods required neurosurgery and were reserved for medically intractable epilepsy or other severe conditions. Today, vagal nerve stimulation can be performed with a minimal-risk non-invasive approach without surgery through a technique called transcutaneous Vagal Nerve Stimulation (tVNS). This project will utilize a home-operated stimulator in healthy young adult and healthy older populations to provide a proof of concept of practical home-use stimulation.

Conditions: Cognitive Performance
Being tested: Transcutaneous Vagal Nerve Stimulation (tVNS)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Transcutaneous Vagal Nerve Stimulation (tVNS)Device
vagal nerve stimulation

Study groups in NCT04484285
Study group	Role	What they receive
Younger Cohort	Active comparator	Healthy individuals aged 18 - 55 Receives: Device: Transcutaneous Vagal Nerve Stimulation (tVNS)
Older Cohort	Active comparator	Healthy individuals aged 56 - 85 Receives: Device: Transcutaneous Vagal Nerve Stimulation (tVNS)

What is being measured

The primary outcome is the main question the study is designed to answer.

System Usability Scale
This is a standard version of a usability scale. Subjects will be given 10 statements regarding the usability of the equipment they used, and they will report how much they agree with each statement on a 1 - 5 scale (1 is strongly disagree and 5 is strongly agree). The score range is 10-50 where 50 demonstrates the highest acceptance of the usability of the device and 10 demonstrates the lowest acceptance of the usability of the device.
Measured: Day 7 reported

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Aug 20206 Sep 2023

First posted23 Jul 2020
Study start20 Aug 2020
Primary completion6 Sep 2023
Study completion6 Sep 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Cognitive PerformanceStudies of the same condition, open and under way.
More trials run by University of FloridaThe 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: Parallel groups
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04484285
Sponsor's protocol ID: IRB201901518 -A
Status last verified: Apr 2025
First submitted: 21 Jul 2020
Last updated: 20 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cognitive Performance trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Home Operations Utilizing Stimulation
ClinicalTrials.gov ID: NCT04484285
Acronym / sponsor ID: IRB201901518 -A
Conditions: Cognitive Performance
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: University of FloridaUniversity, hospital or other
Study start: 20 Aug 2020 (actual)
Primary completion: 6 Sep 2023 (actual)
Study completion: 6 Sep 2023 (actual)
First posted: 23 Jul 2020 (actual)
Results: Posted 11 Apr 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Younger Cohort	Active comparator	Device: Transcutaneous Vagal Nerve Stimulation (tVNS)Healthy individuals aged 18 - 55
Older Cohort	Active comparator	Device: Transcutaneous Vagal Nerve Stimulation (tVNS)Healthy individuals aged 56 - 85

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Participants for one cohort will be adults between the ages of 18-55, consistent with the typical college population
Participants for the other cohort will be adults between the ages of 56 - 85. Participants must read and write English.

Key exclusion criteria (2 listed)

Major medical illnesses including diagnosed severe neurological illnesses (e.g., stroke, seizure history), autoimmune disorders, and severe psychiatric diseases (e.g., schizophrenia) will be excluded. Participants with any history of brain surgery, tumor, intracranial metal implantation, pacemakers or other implanted devices will be excluded.
Sleep medications and/or psychostimulants are exclusionary. Subjects in the older cohort will NOT be excluded for taking blood pressure and cholesterol medication. Participants who are pregnant will be excluded. If participants have a history of adverse reaction to electrical nerve stimulation, they will be excluded.

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 Vagal Nerve Stimulation (tVNS)vagal nerve stimulation	Device	Older Cohort, Younger Cohort

Primary outcome

System Usability Scale
Time frame: Day 7 reported
This is a standard version of a usability scale. Subjects will be given 10 statements regarding the usability of the equipment they used, and they will report how much they agree with each statement on a 1 - 5 scale (1 is strongly disagree and 5 is strongly agree). The score range is 10-50 where 50 demonstrates the highest acceptance of the usability of the device and 10 demonstrates the lowest acceptance of the usability of the device.

Results and safety

Results posted to the registry on 11 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Younger Cohort	9	6
Older Cohort	1	1

Primary outcome: System Usability Scale

Time frame: Day 7 reported. Mean (Standard Deviation). Unit: score on a scale

Measure	Younger Cohort n = 6	Older Cohort n = 1
Value	46.25 (18.53)	10 (NA)

Adverse events

Time frame: 7 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Younger Cohort	0 of 9 (0%)	0 of 9 (0%)	0 of 9
Older Cohort	0 of 1 (0%)	0 of 1 (0%)	0 of 1

Limitations and caveats (from the sponsor): The study enrolled only participant into the older adult group. This participant was unable to use the stimulator. To understand the feasibility of this intervention in this group many more older adult participants would need to be enrolled.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Cognitive Performance

Not yet recruitingObservational study
EEG Markers From Polysomnography and Cognitive Performance in Obstructive Sleep Apnea
Obstructive Sleep Apnea, Cognitive Impairment
Not yet recruiting
Effects of Cognitive Restructuring Intervention on Competitive State Anxiety and Volleyball Skill Performance Among Female Collegiate Volleyball Players in Guangzhou, China
Competitive State Anxiety, Volleyball Skill Performance
Not yet recruiting
Effects of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) on Cognition, Dual-Task Performance, and Interoceptive Accuracy
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Recruiting
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Recruiting
The Efficacy of an IADL-based Non-immersive Virtual Reality Training Program to Enhance ADL Performance and Cognitive Function for Persons at Risk of Dementia
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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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

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 Vagal Nerve Stimulation (tVNS) in people with Cognitive Performance, run by University of Florida 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 20 Apr 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. 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?

Yes. Results are posted in the registry (first posted 11 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

System Usability Scale (time frame: Day 7 reported). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04484285.

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 Apr 2025.