DepressionNCT03592446
Neural Alteration Response to Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) in Depressed Patients
A study testing Transcutaneous electrical vagus nerve stimulation in people with Depression, run by Xidian University.
Trial summary
Electrical vagus nerve stimulation (VNS) was approved by FDA for treatment of chronic recurrent depression in 2005. Recently, non-invasive, transcutaneous auricular vagus nerve stimulation （taVNS） has already been used for depression treatment. Read more about this study
- Who is it for?
- Ages 15 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Transcutaneous electrical vagus nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2018to 30 Jul 2020
- 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 15 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Meets ICD-10 diagnosis standard;
- without taking anti-depressive medication or other psychiatric medications 2 weeks before the experiment;
- Patient has exhibited symptoms for at least 2 months, but no longer than 2 years.
Who cannot join
- With current addiction to drugs;
- With other severe organic diseases, such as severe heart disease, kidney failure etc;
- disagree with the consent form.
- Cannot receive MRI scan.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Xidian University,China
Electrical vagus nerve stimulation (VNS) was approved by FDA for treatment of chronic recurrent depression in 2005. Recently, non-invasive, transcutaneous auricular vagus nerve stimulation （taVNS） has already been used for depression treatment. However, the neural mechanism remains unclear, and the relationship between stimulation parameters and neural response were also unknown. The present study aims to investigate the specific brain activation in depression patients after taVNS，compared with healthy controls.
- Conditions
- Depression
- Being tested
- Transcutaneous electrical vagus nerve stimulation, Sham vagus nerve stimulation
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous electrical vagus nerve stimulationDevice
All subjects receive electrical VNS stimulation at cymba conchae.
Sham vagus nerve stimulationDevice
All subjects receive electrical stimulation at earlobe.
| Study group | Role | What they receive |
|---|---|---|
| Active-raVNS | Experimental | Transcutaneous electrical vagus nerve stimulation at ear. Receives: Device: Transcutaneous electrical vagus nerve stimulation |
| Sham-raVNS | Sham comparator | Sham vagus nerve stimulation at ear. Receives: Device: Sham vagus nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
actual neural activation in brain
By using fMRI technology, the BOLD signal of brain is analyzed.
Measured: 2 hours
Secondary outcomes (1)
Heart rate variability
Frequency domain methods is used to analyze the bands of frequency and then count the number of NN intervals that match each band. The bands are typically high frequency (HF) from 0.15 to 0.4 Hz, low frequency (LF) from 0.04 to 0.15 Hz, and the very low frequency (VLF) from 0.0033 to 0.04 Hz.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start1 Sep 2018 (estimated)
- Primary completion30 Jul 2020 (estimated)
- Study completion30 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xidian University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03592446
- Sponsor's protocol ID
- 81471812
- Status last verified
- Jun 2018
- First submitted
- 26 Jun 2018
- Last updated
- 19 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Xidian University,China
- ClinicalTrials.gov ID
- NCT03592446
- Acronym / sponsor ID
- 81471812
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Xidian UniversityUniversity, hospital or other
- Study start
- 1 Sep 2018 (estimated)
- Primary completion
- 30 Jul 2020 (estimated)
- Study completion
- 30 Jul 2020 (estimated)
- First posted
- 19 Jul 2018 (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.
Electrical vagus nerve stimulation (VNS) was approved by FDA for treatment of chronic recurrent depression in 2005. Recently, non-invasive, transcutaneous auricular vagus nerve stimulation （taVNS） has already been used for depression treatment. However, the neural mechanism remains unclear, and the relationship between stimulation parameters and neural response were also unknown. The present study aims to investigate the specific brain activation in depression patients after taVNS，compared with healthy controls.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active-raVNS | Experimental | Device: Transcutaneous electrical vagus nerve stimulationTranscutaneous electrical vagus nerve stimulation at ear. |
| Sham-raVNS | Sham comparator | Device: Sham vagus nerve stimulationSham vagus nerve stimulation at ear. |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Meets ICD-10 diagnosis standard;
- without taking anti-depressive medication or other psychiatric medications 2 weeks before the experiment;
- Patient has exhibited symptoms for at least 2 months, but no longer than 2 years.
Key exclusion criteria (4 listed)
- With current addiction to drugs;
- With other severe organic diseases, such as severe heart disease, kidney failure etc;
- disagree with the consent form.
- Cannot receive MRI scan.
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 electrical vagus nerve stimulationAll subjects receive electrical VNS stimulation at cymba conchae. | Device | Active-raVNS |
| Sham vagus nerve stimulationAll subjects receive electrical stimulation at earlobe. | Device | Sham-raVNS |
Primary outcome
actual neural activation in brain
Time frame: 2 hours
By using fMRI technology, the BOLD signal of brain is analyzed.
1 secondary outcome
Heart rate variability
Time frame: 2 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2018.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous electrical vagus nerve stimulation in people with Depression, run by Xidian University.
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 4 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 19 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact xuejuan Yang (86-029-81891070, xjyang@xidian.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
actual neural activation in brain (time frame: 2 hours). 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 19 Jul 2018.