HealthyNCT05468385
The Effects of taVNS on Inhibitory Control
A study testing Vagus nerve stimulation via tragus in people with Healthy, run by University of Electronic Science and Technology of China at 1 site in China.
Trial summary
The main aim of the study is to investigate whether the transcutaneous vagus nerve stimulation(tVNS) improves the ability of inhibitory control in an emotional Go-Nogo task. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Vagus nerve stimulation via tragus
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2022to 5 Aug 2022
- 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 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects without past or current psychiatric or neurological disorders
Who cannot join
- history of head injury;
- pregnant, menstruating, taking oral contraceptives;
- medical or psychiatric illness.
Trial locations and contacts
1 site in 1 country.
China1 site
University of Electronic Science and Technology of China
Chengdu, Sichuan, 611731
About this study
Official title: Transcutaneous Auricular Vagus Nerve Stimulation Improves Inhibitory Control in Emotional Go-Nogo Task
The main aim of the study is to investigate whether the transcutaneous vagus nerve stimulation(tVNS) improves the ability of inhibitory control in an emotional Go-Nogo task.
Read the detailed description
A randomized, sham-controlled, between-subject design will be employed in this study. A total of 87 healthy subjects will receive either transcutaneous vagus nerve stimulation via tragus or sham stimulation via the earlobe in the left ear. Brain activity and behavioral data for an emotional Go-Nogo task will be recorded and saliva samples will be collected before, during, and after stimulation.
Some personal traits will be assessed using different kinds of questionnaires, such as the State-Trait Anxiety Inventory (STAI), Beck's Depression Inventory(BDI), Autism Spectrum Quotient (ASQ) et al.
- Conditions
- Healthy
- Being tested
- Vagus nerve stimulation via tragus, Sham stimulation via earlobe
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vagus nerve stimulation via tragusDevice
The device will send stimulus intensity of around 0.5mA via tragus in the left ear (based on participants' subjective report), delivered with a pulse width of 0.5 ms at 25 Hz. Stimulation will be active for 30 seconds, followed by a break of 30 seconds.
Sham stimulation via earlobeDevice
The device will send stimulus intensity of around 0.5mA via the earlobe in the left ear (based on participants' subjective reports), delivered with a pulse width of 0.5 ms at 25 Hz. Stimulation will be active for 30 seconds, followed by a break of 30 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Tragus stimulation | Experimental | Vagus nerve stimulation via tragus Receives: Device: Vagus nerve stimulation via tragus |
| Sham stimulation | Sham comparator | Sham stimulation via earlobe Receives: Device: Sham stimulation via earlobe |
What is being measured
The primary outcome is the main question the study is designed to answer.
The ability of inhibitory control in an emotional Go-Nogo task
Analysis the behavioral and brain data recorded during the task
Measured: After 30 minutes stimulation
Oxytocin release
Investigating the oxytocin release after taVNS via tragus and earlobe based on saliva samples
Measured: within 5 minutes after taVNS via tragus and earlobe
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2022
- Study start1 May 2022
- Primary completion20 Jul 2022
- Study completion5 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Electronic Science and Technology of China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keith Kendrick, University of Electronic Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05468385
- Sponsor's protocol ID
- UESTC-neuSCAN-90
- Status last verified
- Dec 2023
- First submitted
- 15 Jul 2022
- Last updated
- 13 Dec 2023
- 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 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Auricular Vagus Nerve Stimulation Improves Inhibitory Control in Emotional Go-Nogo Task
- ClinicalTrials.gov ID
- NCT05468385
- Acronym / sponsor ID
- UESTC-neuSCAN-90
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of Electronic Science and Technology of ChinaUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 20 Jul 2022 (actual)
- Study completion
- 5 Aug 2022 (actual)
- First posted
- 21 Jul 2022 (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 main aim of the study is to investigate whether the transcutaneous vagus nerve stimulation(tVNS) improves the ability of inhibitory control in an emotional Go-Nogo task.
Detailed description
A randomized, sham-controlled, between-subject design will be employed in this study. A total of 87 healthy subjects will receive either transcutaneous vagus nerve stimulation via tragus or sham stimulation via the earlobe in the left ear. Brain activity and behavioral data for an emotional Go-Nogo task will be recorded and saliva samples will be collected before, during, and after stimulation.
Some personal traits will be assessed using different kinds of questionnaires, such as the State-Trait Anxiety Inventory (STAI), Beck's Depression Inventory(BDI), Autism Spectrum Quotient (ASQ) et al.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tragus stimulation | Experimental | Device: Vagus nerve stimulation via tragusVagus nerve stimulation via tragus |
| Sham stimulation | Sham comparator | Device: Sham stimulation via earlobeSham stimulation via earlobe |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy subjects without past or current psychiatric or neurological disorders
Key exclusion criteria (3 listed)
- history of head injury;
- pregnant, menstruating, taking oral contraceptives;
- medical or psychiatric illness.
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 |
|---|---|---|
| Vagus nerve stimulation via tragusThe device will send stimulus intensity of around 0.5mA via tragus in the left ear (based on participants' subjective report), delivered with a pulse width of 0.5 ms at 25 Hz. Stimulation will be active for 30 seconds, followed by a break of 30 seconds. | Device | Tragus stimulation |
| Sham stimulation via earlobeThe device will send stimulus intensity of around 0.5mA via the earlobe in the left ear (based on participants' subjective reports), delivered with a pulse width of 0.5 ms at 25 Hz. Stimulation will be active for 30 seconds, followed by a break of 30 seconds. | Device | Sham stimulation |
Primary outcome
The ability of inhibitory control in an emotional Go-Nogo task
Time frame: After 30 minutes stimulation
Analysis the behavioral and brain data recorded during the task
Oxytocin release
Time frame: within 5 minutes after taVNS via tragus and earlobe
Investigating the oxytocin release after taVNS via tragus and earlobe based on saliva samples
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
- 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 Vagus nerve stimulation via tragus in people with Healthy, run by University of Electronic Science and Technology of China at 1 site in China.
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 3 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 13 Dec 2023. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The ability of inhibitory control in an emotional Go-Nogo task (time frame: After 30 minutes stimulation). 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 13 Dec 2023.