no ConditionNCT04455295
Testing the Noradrenergic Hypothesis of Transcutaneous Vagus Nerve Stimulation
A study testing Transdermal Vagus Nerve Stimulation (tVNS) in people with no Condition and Electroencephalography, run by Arkansas Tech University at 1 site in United States.
Trial summary
This study investigates the capacity of non-invasive vagus nerve stimulation, applied at the ear, to alter to measures of locus coeruleus output pupil diameter and EEG alpha power. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- no Condition, Electroencephalography, Pupil Diameter
- What is being tested?
- Transdermal Vagus Nerve Stimulation (tVNS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2020to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy, 18 years of age or older.
Who cannot join
- self-report of mood disorders, prescription and non-prescription drug use which includes stimulants including caffeine and nicotine
Trial locations and contacts
1 site in 1 country.
United States1 site
Arkansas Tech University
Russellville, Arkansas, 72801
About this study
This study investigates the capacity of non-invasive vagus nerve stimulation, applied at the ear, to alter to measures of locus coeruleus output pupil diameter and EEG alpha power. Non-invasive alteration in locus coeruleus output is of interest in regard to basic science and has potential clinical implications in a number of conditions.
- Conditions
- no Condition, Electroencephalography, Pupil Diameter
- Being tested
- Transdermal Vagus Nerve Stimulation (tVNS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transdermal Vagus Nerve Stimulation (tVNS)Device
Mild non-invasive transdermal electrical stimulation at the ear (0.0-1.0 mA, 0.0-30.0 Hz). Used in previous studies with no unexpected adverse events. Stimulator not considered a FDA regulated device in previous studies.
| Study group | Role | What they receive |
|---|---|---|
| Active Stimulation 0.5 | Experimental | 0.5mA, 30Hz intermittent transdermal vagus nerve stimulation of the auricle vagus. Stimulation 30 second on/30 seconds off for five cycles. Receives: Device: Transdermal Vagus Nerve Stimulation (tVNS) |
| Lobe Control | Placebo comparator | 0.5mA, 30Hz intermittent transdermal vagus nerve stimulation of the earlobe. Stimulation 30 second on/30 seconds off for five cycles. Receives: Device: Transdermal Vagus Nerve Stimulation (tVNS) |
| Sham Stimulation | Placebo comparator | 0.5mA, 5Hz intermittent transdermal vagus nerve stimulation of the auricle vagus. Stimulation 30 second on/30 seconds off for five cycles. Receives: Device: Transdermal Vagus Nerve Stimulation (tVNS) |
| Nonstimulation | Placebo comparator | Placement of electrode without any stimulation. Receives: Device: Transdermal Vagus Nerve Stimulation (tVNS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pupil Diameter
Pupil diameter is measured via camera.
Measured: Within single one hour session
EEG Alpha power.
Alpha power will be determined from EEG.
Measured: Within single one hour session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start1 Sep 2020
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for no ConditionStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arkansas Tech University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04455295
- Sponsor's protocol ID
- Roosevelt_102218
- Status last verified
- Feb 2024
- First submitted
- 29 Jun 2020
- Last updated
- 28 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Noradrenergic Hypothesis of Transcutaneous Vagus Nerve Stimulation
- ClinicalTrials.gov ID
- NCT04455295
- Acronym / sponsor ID
- Roosevelt_102218
- Conditions
- no Condition, Electroencephalography, Pupil Diameter
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Arkansas Tech UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 2 Jul 2020 (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 investigates the capacity of non-invasive vagus nerve stimulation, applied at the ear, to alter to measures of locus coeruleus output pupil diameter and EEG alpha power. Non-invasive alteration in locus coeruleus output is of interest in regard to basic science and has potential clinical implications in a number of conditions.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Active Stimulation 0.5 | Experimental | Device: Transdermal Vagus Nerve Stimulation (tVNS)0.5mA, 30Hz intermittent transdermal vagus nerve stimulation of the auricle vagus. Stimulation 30 second on/30 seconds off for five cycles. |
| Lobe Control | Placebo comparator | Device: Transdermal Vagus Nerve Stimulation (tVNS)0.5mA, 30Hz intermittent transdermal vagus nerve stimulation of the earlobe. Stimulation 30 second on/30 seconds off for five cycles. |
| Sham Stimulation | Placebo comparator | Device: Transdermal Vagus Nerve Stimulation (tVNS)0.5mA, 5Hz intermittent transdermal vagus nerve stimulation of the auricle vagus. Stimulation 30 second on/30 seconds off for five cycles. |
| Nonstimulation | Placebo comparator | Device: Transdermal Vagus Nerve Stimulation (tVNS)Placement of electrode without any stimulation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy, 18 years of age or older.
Key exclusion criteria (1 listed)
- self-report of mood disorders, prescription and non-prescription drug use which includes stimulants including caffeine and nicotine
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 |
|---|---|---|
| Transdermal Vagus Nerve Stimulation (tVNS)Mild non-invasive transdermal electrical stimulation at the ear (0.0-1.0 mA, 0.0-30.0 Hz). Used in previous studies with no unexpected adverse events. Stimulator not considered a FDA regulated device in previous studies. | Device | Active Stimulation 0.5, Lobe Control, Nonstimulation, Sham Stimulation |
Primary outcome
Pupil Diameter
Time frame: Within single one hour session
Pupil diameter is measured via camera.
EEG Alpha power.
Time frame: Within single one hour session
Alpha power will be determined from EEG.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: No
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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 Transdermal Vagus Nerve Stimulation (tVNS) in people with no Condition and Electroencephalography, run by Arkansas Tech 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 28 Feb 2024. 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?
Results are not available in the source record.
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?
Pupil Diameter (time frame: Within single one hour session). The study lists 2 primary outcomes in all. 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 28 Feb 2024.