DepressionNCT06026904
The Effects of taVNS on Motivation in MDD With Anhedonia
A study testing transcutaneous auricular vagus nerve stimulation in people with Depression, run by Anhui Medical University at 1 site in China.
Trial summary
Study of non-invasive transcutaneous auricular vagus nerve stimulation (taVNS) intervention to improve the reward motivation and response inhibition of major depression disorder and its brain network mechanism. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Depression
- What is being tested?
- transcutaneous auricular 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
- 1 siteChina
- Study dates
- 30 Mar 2023to 30 Sep 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Meet the criteria of depression assessed by at least two psychiatrists according to the fifth version of Diagnostic and Statistical Manual of Mental Disorders.
- The score of Hamilton Depression Rating Scale-17 is larger than 18 and the score of the Apathy Evaluation scale is lager than 37.
- Patients were taking antidepressants--Selective Serotonin Reuptake Inhibitor(SSRIs) alone.
- Age was between 18 to 60 year old. The education duration was at least 6 years.
- The vision or corrected vision was normal.
- Right handedness.
- No treatment of rTMS, transcranial direct current stimulation, or electroconvulsive therapy before.
Who cannot join
- History of significant head trauma or neurological disorders.
- Alcohol or drug abuse.
- Focal brain lesions.
- History of seizure.
- First degree relative with epilepsy, significant neurological illness or head trauma, endocrine disease.
- Significant unstable medical condition.
Show all 12Show fewer
- Recent aggression or other forms of behavioral dyscontrol.
- Left-handedness.
- Pregnancy.
- Current alcohol or drug abuse
- Inability to provide informed consent.
- Patients with contraindications or factors affecting imaging quality, such as pacemakers, cochlear implants, or hearts Cerebrovascular metal stent, and metal denture.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Transcutaneous Auricular Vagus Nerve Stimulation on Motivation in Major Depressive Disorder With Anhedonia
Study of non-invasive transcutaneous auricular vagus nerve stimulation (taVNS) intervention to improve the reward motivation and response inhibition of major depression disorder and its brain network mechanism.
Read the detailed description
Anhedonia is the core symptom of MDD, which means they have deficits in processing rewards.MDD get lesser positive feelings than healthy controls from rewards as they could not use the reward outcome to update the value of a stimulus, which in consequence impedes their reward motivation or response inhibition and worsen their symptom. This study is dedicated to revealing how reward motivation or response inhibition ability could be intervened by taVNS intervention, which has been proven is highly relevant to reward motivation and response inhibition ability. Implementing a safer intervention of taVNS stimulation might help us to prove a better treatment for patients.
All patients underwent a medical evaluation that included physical examination and routine laboratory studies before and after taVNS stimulation treatment. Before and after the taVNS treatment, depression symptom of each participant was assessed by the Hamilton Depression Scale and the Beck Depression Self-Rating Scale. The anhedonia severity was evaluated by The Temporal Experience of Pleasure Scale, the Self-Report Apathy Evaluation Scale, the Positive Valence system scale and the Motivation and Pleasure Scale. The neuroimaging data are collected using event-related potentials during the effort reward task and stop signal task before and after the intervention. Patients were randomly allocated into an active group and a sham group. This study plans to enroll a minimum total sample size of 30 participants in active and sham group respectively according to the Power and Sample Size program. The decision to enroll a patient was always made prior to randomization. Each patient will be treated for 4 weeks with 25Hz taVNS. Each participant was interviewed in detail about the adverse event of the taVNS intervention during 10 days. Every participant should take part in the study voluntarily and sign an informed consent form before the study.
- Conditions
- Depression
- Being tested
- transcutaneous auricular vagus nerve stimulation
- Keywords
- taVNS, anhedonia, intervention
- Medical subject headings
- Depression, Anhedonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous auricular vagus nerve stimulationDevice
taVNS was developed as a non-invasive variant of VNS where the vagus nerve is stimulated through the skin of the auricle, which has become a promising avenue for research and, potentially, treatment of various disorders. Commonly, taVNS is applied via the ear targeting the auricular branch of the vagus nerve, where the stimulation elicits far-field potentials. In line with preclinical studies, acute taVNS enhances invigoration of effort and response inhibition capability.
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator: Real Stimulation | Active comparator | The active Stimulation of taVNS lasted 30 mins. The stimulation protocol is preset to a biphasic impulse frequency of 25 Hz with a stimulation duration of 30 s, followed by a 30 s off phase. Behavior and ERPs datasets should be acquired before the first taVNS session and after the last taVNS session.The electrical current is transmitted by a titanium electrode placed at the cymba conchae. Receives: Device: transcutaneous auricular vagus nerve stimulation |
| Sham Comparator: Sham Stimulation | Sham comparator | The active Stimulation of taVNS lasted 30 mins. The stimulation protocol is preset to a biphasic impulse frequency of 25 Hz with a stimulation duration of 30 s, followed by a 30 s off phase. Behavior and ERPs datasets should be acquired before the first taVNS session and after the last taVNS session.The electrical current is transmitted by a titanium electrode placed at the earlobe of the midpoint of the outer ear margin. Receives: Device: transcutaneous auricular vagus nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Hamilton Depression Scale
The participants' depression symptom assessed by the Hamilton Depression Scale change from baseline after the treatment. Score reference value: <7 points, no depression;7 to 17points, mild depression;18to 24 points, moderate depression; > 24 points, severe depression. If remission rate reaches 50%, the treatment will be considered effective.
Measured: baseline;10days after treatment; 1month and 3 month post-treatment
Change from baseline in Apathy Evaluation Scale
The participants' reward motivation assessed by the Apathy Evaluation Scale change from baseline after the treatment. Score reference value: <37 points, no apathy; ≥37points, apathy. If remission rate reaches 25%, the treatment will be considered effective.
Measured: baseline;10days after treatment; 1month and 3 month post-treatment
Secondary outcomes (4)
The change from baseline in behavioral results of effort reward task
Behavioral results changed and discount parameters generated from the model change from baseline after the treatment.
Measured: baseline;4 weeks post-treatment
The change from baseline in event-related brain potentials during the effort reward task
The amplitudes of brain potentials of reward-related positivity and P3 assessed by event-related brain potentials methods change from baseline after the treatment.
Measured: baseline;4 weeks post-treatment
The change from baseline in behavioral results of stop signal task
Behavioral results changed from baseline after the treatment.
Measured: baseline;4 weeks post-treatment
The change from baseline in event-related brain potentials during the stop signal task
Cue-evoked cue-P3 and N2 mean wave amplitude changes and latencies, as well as spectral intensities. Wave amplitude and latency of target-P3 and N2 evoked by target stimuli, and spectral activity.
Measured: baseline;4 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start30 Mar 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Sep 2025 (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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will enroll two groups of patients with Major Depressive Disorder (MDD): one group will receive active transcutaneous auricular Vagus Nerve Stimulation (taVNS) treatment, while the other group will receive sham taVNS treatment (the same flow path, but targeting a different stimulation site).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fengqiong Yu, Anhui Medical University
- Investigators
- Kai Wang, MD, Study chair, Anhui Medical UniversityFengqiong Yu, MD, Study director, Anhui Medical UniversityRong Ye, Phd, Study director, Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06026904
- Sponsor's protocol ID
- Y&C
- Status last verified
- Jun 2024
- First submitted
- 31 Aug 2023
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Transcutaneous Auricular Vagus Nerve Stimulation on Motivation in Major Depressive Disorder With Anhedonia
- ClinicalTrials.gov ID
- NCT06026904
- Acronym / sponsor ID
- Y&C
- Conditions
- Depression
- Keywords
- taVNS, anhedonia, intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Anhui Medical UniversityUniversity, hospital or other
- Study start
- 30 Mar 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 7 Sep 2023 (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.
Study of non-invasive transcutaneous auricular vagus nerve stimulation (taVNS) intervention to improve the reward motivation and response inhibition of major depression disorder and its brain network mechanism.
Detailed description
Anhedonia is the core symptom of MDD, which means they have deficits in processing rewards.MDD get lesser positive feelings than healthy controls from rewards as they could not use the reward outcome to update the value of a stimulus, which in consequence impedes their reward motivation or response inhibition and worsen their symptom. This study is dedicated to revealing how reward motivation or response inhibition ability could be intervened by taVNS intervention, which has been proven is highly relevant to reward motivation and response inhibition ability. Implementing a safer intervention of taVNS stimulation might help us to prove a better treatment for patients.
All patients underwent a medical evaluation that included physical examination and routine laboratory studies before and after taVNS stimulation treatment. Before and after the taVNS treatment, depression symptom of each participant was assessed by the Hamilton Depression Scale and the Beck Depression Self-Rating Scale. The anhedonia severity was evaluated by The Temporal Experience of Pleasure Scale, the Self-Report Apathy Evaluation Scale, the Positive Valence system scale and the Motivation and Pleasure Scale. The neuroimaging data are collected using event-related potentials during the effort reward task and stop signal task before and after the intervention. Patients were randomly allocated into an active group and a sham group. This study plans to enroll a minimum total sample size of 30 participants in active and sham group respectively according to the Power and Sample Size program. The decision to enroll a patient was always made prior to randomization. Each patient will be treated for 4 weeks with 25Hz taVNS. Each participant was interviewed in detail about the adverse event of the taVNS intervention during 10 days. Every participant should take part in the study voluntarily and sign an informed consent form before the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study will enroll two groups of patients with Major Depressive Disorder (MDD): one group will receive active transcutaneous auricular Vagus Nerve Stimulation (taVNS) treatment, while the other group will receive sham taVNS treatment (the same flow path, but targeting a different stimulation site).
| Arm | Type | Receives |
|---|---|---|
| Active Comparator: Real Stimulation | Active comparator | Device: transcutaneous auricular vagus nerve stimulationThe active Stimulation of taVNS lasted 30 mins. The stimulation protocol is preset to a biphasic impulse frequency of 25 Hz with a stimulation duration of 30 s, followed by a 30 s off phase. Behavior and ERPs datasets should be acquired before the first taVNS session and after the last taVNS session.The electrical current is transmitted by a titanium electrode placed at the cymba conchae. |
| Sham Comparator: Sham Stimulation | Sham comparator | Device: transcutaneous auricular vagus nerve stimulationThe active Stimulation of taVNS lasted 30 mins. The stimulation protocol is preset to a biphasic impulse frequency of 25 Hz with a stimulation duration of 30 s, followed by a 30 s off phase. Behavior and ERPs datasets should be acquired before the first taVNS session and after the last taVNS session.The electrical current is transmitted by a titanium electrode placed at the earlobe of the midpoint of the outer ear margin. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Meet the criteria of depression assessed by at least two psychiatrists according to the fifth version of Diagnostic and Statistical Manual of Mental Disorders.
- The score of Hamilton Depression Rating Scale-17 is larger than 18 and the score of the Apathy Evaluation scale is lager than 37.
- Patients were taking antidepressants--Selective Serotonin Reuptake Inhibitor(SSRIs) alone.
- Age was between 18 to 60 year old. The education duration was at least 6 years.
- The vision or corrected vision was normal.
Key exclusion criteria (12 listed)
- History of significant head trauma or neurological disorders.
- Alcohol or drug abuse.
- Focal brain lesions.
- History of seizure.
- First degree relative with epilepsy, significant neurological illness or head trauma, endocrine disease.
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 stimulationtaVNS was developed as a non-invasive variant of VNS where the vagus nerve is stimulated through the skin of the auricle, which has become a promising avenue for research and, potentially, treatment of various disorders. Commonly, taVNS is applied via the ear targeting the auricular branch of the vagus nerve, where the stimulation elicits far-field potentials. In line with preclinical studies, acute taVNS enhances invigoration of effort and response inhibition capability. | Device | Active Comparator: Real Stimulation, Sham Comparator: Sham Stimulation |
Primary outcome
Change from baseline in Hamilton Depression Scale
Time frame: baseline;10days after treatment; 1month and 3 month post-treatment
The participants' depression symptom assessed by the Hamilton Depression Scale change from baseline after the treatment. Score reference value: <7 points, no depression;7 to 17points, mild depression;18to 24 points, moderate depression; > 24 points, severe depression. If remission rate reaches 50%, the treatment will be considered effective.
Change from baseline in Apathy Evaluation Scale
Time frame: baseline;10days after treatment; 1month and 3 month post-treatment
The participants' reward motivation assessed by the Apathy Evaluation Scale change from baseline after the treatment. Score reference value: <37 points, no apathy; ≥37points, apathy. If remission rate reaches 25%, the treatment will be considered effective.
4 secondary outcomes
The change from baseline in behavioral results of effort reward task
Time frame: baseline;4 weeks post-treatment
The change from baseline in event-related brain potentials during the effort reward task
Time frame: baseline;4 weeks post-treatment
The change from baseline in behavioral results of stop signal task
Time frame: baseline;4 weeks post-treatment
The change from baseline in event-related brain potentials during the stop signal task
Time frame: baseline;4 weeks post-treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
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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.
Kai Wang, MD study chair
Anhui Medical University
Fengqiong Yu, MD study director
Anhui Medical University
Rong Ye, Phd study director
Anhui Medical 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 in people with Depression, run by Anhui Medical University 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 7 inclusion and 12 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 26 Jun 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 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?
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?
Change from baseline in Hamilton Depression Scale (time frame: baseline;10days after treatment; 1month and 3 month post-treatment). 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 26 Jun 2024.