Post-COVID-19 SyndromeNCT06510985
Transcutaneous Vagus Nerve Stimulation (tVNS) for Improved Recovery After Exertion.
A study testing transcutaneous vagus nerve stimulation, Monitoring and cardiowatch bracelet in people with Post-COVID-19 Syndrome, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
Widespread infection with SARS-CoV-2 has resulted in millions of people having Post-COVID. Post-COVID is a complex, non-monolithic disease with diverse clinical manifestations. Symptoms range from fatigue, brain fog, muscle aches and shortness of breath, affecting multiple organ systems simultaneously. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post-COVID-19 Syndrome
- What is being tested?
- transcutaneous vagus nerve stimulation, Monitoring and cardiowatch bracelet
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- 19 Jul 2024to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- individuals who have previously tested positive for SARS-CoV-2 infection (preferred PCR-Test) or have a medically confirmed history of COVID-19 (preferred SARS-CoV-2 Antibody-test) and have persistent symptoms (including Post-COVID) .
- clinical diagnoses made by physician: individuals are included with at least one persistent symptom for at least 4 weeks (Long-COVID) or at least 8 weeks (Post-COVID) following the SARS-CoV-2 infections, such as fatigue, shortness of breath, brain fog, headaches, irritability, cognitive difficulties, muscle or joint pain, sleep disturbances, etc.
- Participants should not have an alternative explanation for their persistent symptoms, ruling out other medical or psychiatric conditions.
Who cannot join
- lack of capacity for consent
- insufficient German language skills: Participants must have sufficient (B2 German) language skills to understand the informed consent form, study procedures, and questionnaires.
- Intensive Care Unit treatment during COVID-19 infection
- BMI > 18.5 \& BMI < 30 kg/m2
- Lifetime (according to DSM 5):
- brain injury, stroke, epilepsy, or history of seizures
Show all 15Show fewer
- schizophrenia
- bipolar disorder
- severe substance use disorders, except tobacco
- cardiac arrhythmia, coronary heart disease
- 12-month prevalence: pregnancy or nursing
- Additional exclusion criteria for a safe application of tVNS:
- active implant (pacemaker, cochlear implant, implanted electrode device) and cerebral shunts
- required permanent use of left-sided hearing aid
- ear infections, open wounds, or impaired skin at electrode sites
Trial locations and contacts
1 site in 1 country.
Germany1 site
Translational Psychiatry, Department of Psychiatry and Psychotherapy, University Hosptial Tübingen
Tübingen
About this study
Official title: Transcutaneous Vagus Nerve Stimulation (tVNS) for Improved Recovery After Exertion in Patients With Long/Post-COVID.
Widespread infection with SARS-CoV-2 has resulted in millions of people having Post-COVID. Post-COVID is a complex, non-monolithic disease with diverse clinical manifestations. Symptoms range from fatigue, brain fog, muscle aches and shortness of breath, affecting multiple organ systems simultaneously. To directly address this multi-organ component of Post-COVID, innovative treatment methods are urgently needed. One potential treatment that we will investigate in our study, is the intervention via the vagus nerve, as the cranial nerve plays a central role in communication between the body and the brain and influences targeted behavior. This innovative approach is based on our clinically relevant findings regarding the effects where acute tVNS increased the level of effort (Neuser et al., 2020; Ferstl et al., 2021), specifically targeting a key symptom of Post-COVID. In the proposed study, the investigators aim to investigate the effectiveness of transcutaneous vagus nerve stimulation (tVNS) as a non-invasive, self-administered treatment for Post-COVID symptoms at home. To evaluate the clinically relevant effects of repeated taVNS application (high-intensity stimulation), the investigators will employ a randomized cross-over design to investigate stimulation-induced changes in fatigue, depression and motivation to work for reward compared to low-intensity stimulation and to a control group.
Read the detailed description
The proposed study aims to advance the understanding of Post-COVID treatment using a randomized cross-over design to evaluate the taVNS-induced changes over 12 weeks. A hundred twenty patients diagnosed with Long/Post-COVID are randomly assigned to one of three groups related to the two arms of the study ("Monitoring with low/high-intensity stimulation" vs. Monitoring without stimulation"). In the treatment group, forty patients will start with high-intensity taVNS for 6 weeks, then switch to low-intensity stimulation for an additional 6 weeks. Another 40 patients begin with low-intensity stimulation for 6 weeks, followed by high-intensity taVNS stimulation. The control group ("Monitoring without stimulation") is able to receive taVNS after participation in the study.
The treatment group and the control group will participate in the same monitoring procedures. All participants will attend an initial laboratory session to complete several baseline assessments, including questionnaires, measuring energy expenditure via indirect calorimetry and completing a body silhouette task. Blood samples are taken at every session to evaluate changes in metabolic and inflammatory markers. To assess the motivation to work for rewards, the investigators employ an effort-based-cost-benefit paradigm (Effort Allocation Task). All these lab assessments will be repeated after 6 and 12 weeks to evaluate stimulation-induces changes in primary and secondary outcomes. In addition, all participants are given a cardio bracelet to monitor physiological parameters (e.g. heart rate, heart rate variability, breathing, skin conductance, step counts) over the study period. Over the 12 weeks, the treatment group will self-administer taVNS for four hours daily in a targeted manner, anticipating forthcoming exertion and stimulating in anticipation of an effortful event to enhance the patients' motivational drive and recovery. Another essential part of the study is the monitoring over the 12 weeks. All participants will complete daily ecological momentary assessments via smartphone to monitor their mental states. In addition, participants will perform once a day one of two discounting games (effort or temporal discounting task) to investigate changes in their decision behavior over time. The effort discounting task is essential to assess the motivation of post-COVID patients to pursue subjectively effortful situations over the 12 weeks.
- Conditions
- Post-COVID-19 Syndrome
- Being tested
- transcutaneous vagus nerve stimulation, Monitoring, cardiowatch bracelet
- Keywords
- Post-COVID-19 Syndrome, taVNS, effort, fatigue, heart rate
- Medical subject headings
- Post-Acute COVID-19 Syndrome, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous vagus nerve stimulationDevice
The study employs a CE-certified tVNS® E device, ensuring European safety standards (EU regulation 2017/745 on medical devices). This device features a stimulation cycle of 28 seconds on and 32 seconds off, with a 25 Hz impulse frequency. For the high-intensity group, the stimulation intensity will be individually adjusted in the session before starting the high-intensity tVNS stimulation at home. Recommended daily usage is max. 4 hours, after which it automatically shuts off.
MonitoringBehavioural
Participants are monitored over 12 weeks using a combination of questionnaires and ecological momentary assessment. This approach allows for a comprehensive assessment of the patient's health and well-being.
cardiowatch braceletDevice
The study employs the medically certified cardiowatch bracelet from Corsano (CE-MDR medical certification, FDA 510 (k) cleared) for continuous monitoring of vital signals, such as heart rate, heart rate variability, breathing rate, SpO2, physical activity and sleep.
| Study group | Role | What they receive |
|---|---|---|
| Monitoring with high/low-intensity stimulation | Experimental | The cross-over design includes one group which starts with high-intensity stimulation (n = 40) and another group, who starts with low-intensity stimulation (n = 40). The first group receives at first high-intensity for 6 weeks, followed by a low-intensity stimulation phase for 6 weeks. To control for placebo effects, other forty individuals start with the 6-week low-intensity stimulation phase followed by 6 weeks of high-intensity tVNS stimulation phase. Receives: Device: transcutaneous vagus nerve stimulation; Behavioral: Monitoring; Device: cardiowatch bracelet |
| Monitoring without stimulation | Experimental | Another group of patients is included as a control group (n = 40) undergoing 'treatment as usual' for Long/Post Covid. This group of participants receive the same monitoring throughout their participation during 12 weeks as the Stimulation-Group. As there is no standardized treatment protocol for Long/Post Covid, 'treatment as usual' implies a supportive approach.
This group of participants have the option to receive taVNS stimulation after participating in the study. Receives: Behavioral: Monitoring; Device: cardiowatch bracelet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stimulation-induced changes in invigoration: frequency of button presses during the first seconds of the trial to gain monetary rewards in the Effort Allocation Task.
Changes in invigoration to work for rewards are operationalized as the relative increase in the frequency of button presses on an Xbox controller during the first seconds of the trial in the Effort Allocation Task.
Measured: Pre treatment vs. after 6-week tVNS vs. after 6-week low-intensity stimulation phase
Stimulation-induced changes in symptoms of depression
Changes in symptoms of depression are measured via the Montgomery Asberg Depression Scale. The MADRS comprises 10 items rated on a scale from 0 to 6 to compute a sum score with higher scores indicating severe symptoms of depression.
Measured: Pre treatment vs. after 6-week tVNS vs. after 6-week low-intensity stimulation phase
Stimulation-induced changes in physical and mental aspects of fatigue
Changes in fatigue are measured by the Chalder Fatigue scale. The CFS comprises 11 questions rated on a 4-point Likert scale to compute a sum score.
It will be measured three times six weeks apart.
Measured: Pre treatment vs. after 6-week tVNS vs. after 6-week low-intensity stimulation phase
Secondary outcomes (13)
Stimulation-induced changes in heart rate variability
Changes in heart rate variability are measured by a cardiowatch bracelet to evaluate autonomic nervous system activity.
It will be measured over three months daily.
Measured: during 6-week tVNS compared to during 6-week low-intensity stimulation phase
Stimulation-induced changes in physical activity
Changes in physical activity are measured by step count per day, which are recorded by the cardiowatch bracelet.
It will be measured over three months daily.
Measured: during 6-week tVNS compared to during 6-week low-intensity stimulation phase
Stimulation-induced changes in wanting the monetary rewards
Changes in wanting monetary rewards are measured via a visual analogue scale rating after each effortful trial in the Effort Allocation Task.
It will be measured three times six weeks apart.
Measured: Pre treatment vs. after 6-week tVNS vs. after 6-week low-intensity stimulation phase
Stimulation-induced changes in exertion
Changes in exertion are measured via a visual analogue scale rating after each effortful trial.
It will be measured three times six weeks apart.
Measured: Pre treatment vs. after 6-week tVNS vs. after 6-week low-intensity stimulation phase
Stimulation-induced changes in the motivation to invest effort: the discounting rate reflecting rewards devalued by effort
Changes in the motivation to invest effort is quantified by estimating the participant-specific discounting factor (k) and the inverse temperature parameter (β), which are derived by fitting the participant's observed choice behavior in the effort discounting task to discounting models.
It will be measured at least twice a week over three months.
Measured: during 6-week tVNS compared to during 6-week low-intensity stimulation phase
Stimulation-induced changes in metabolic and inflammatory markers
Metabolic hormone levels and inflammatory markers are assessed from blood samples.
It will be measured three times six weeks apart.
Measured: Pre treatment vs. after 6-week tVNS vs. after 6-week low-intensity stimulation phase
Stimulation-induced changes in health-related quality of life
Changes in health-related quality of life are measured by the Short-Form-12 health survey (SF-12), consisting of 12 questions (weighted sum score).
It will be measured three times six weeks apart.
Measured: Pre treatment vs. after 6-week tVNS vs. after 6-week low-intensity stimulation phase
Stimulation-induced changes in mood and mood response to effort
Changes in positive and negative mood ratings are measured with the questions of the Positive and Negative Affect Schedule (PANAS) questionnaire on visual analog scales (0-100) four times within each experimental session. For each assessment (4x3 time points), all items will be included in the analyses as repeated measures for NA and PA, respectively.
Measured: Pre treatment vs. after 6-week tVNS vs. after 6-week low-intensity stimulation phase
Stimulation-induced changes in maintenance:the average relative frequency across the complete trial to gain monetary rewards in the Effort Allocation Task.
Changes in motivation to work for rewards are operationalized as the average relative increase in the frequency of button presses on an Xbox controller across the complete trial in the Effort allocation task.
Measured: Pre treatment vs. after 6-week tVNS vs. after 6-week low-intensity stimulation phase
Stimulation-induced changes in heart rate
Changes in heart rate are measured by a cardiowatch bracelet depending on physical activity phases
Measured: during 6-week tVNS compared to during 6-week low-intensity stimulation phase
Stimulation-induced changes in effort utility
Effort utility will be calculated as the correlation between trial-wise wanting ratings and effort maintenance (i.e., average button press frequency over the trial).
Measured: Pre-treatment vs. after 6-week tVNS vs. after 6-week low-intensity stimulation phase
stimulation-induced changes in self-reported depressive symptoms
Changes in self-reported depressive symptoms will be assessed using the Beck Depression Inventory-II (BDI-II). The BDI consists of 20 items and a sum score is calculated across all items.
Measured: Pre treatment vs. after 6-week tVNS vs. after 6-week low-intensity stimulation phase
Stimulation-induced changes in HR
HR is measured continuously with the CardioWatch bracelet during the intervention phases between sessions. HR parameters will be calculated for ~1 h time intervals in which participants reported being at rest each day, to compare changes in resting HR.
Measured: During 6-week tVNS compared to during 6-week low-intensity stimulation phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start19 Jul 2024
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-COVID-19 SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nils B. Kroemer, Prof. Dr., Principal investigator, Department of Psychiatry & Psychotherapy, University of Tübingen,Tübingen, 72076Andreas J. Fallgatter, Prof. Dr., Principal investigator, Department of Psychiatry & Psychotherapy, University of Tübingen,Tübingen, 72076
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06510985
- Sponsor's protocol ID
- TUE012_tvns_longCovid
- Status last verified
- Aug 2026
- First submitted
- 17 Jul 2024
- Last updated
- 9 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Vagus Nerve Stimulation (tVNS) for Improved Recovery After Exertion in Patients With Long/Post-COVID.
- ClinicalTrials.gov ID
- NCT06510985
- Acronym / sponsor ID
- TUE012_tvns_longCovid
- Conditions
- Post-COVID-19 Syndrome
- Keywords
- Post-COVID-19 Syndrome, taVNS, effort, fatigue, heart rate
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 19 Jul 2024 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 19 Jul 2024 (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.
Widespread infection with SARS-CoV-2 has resulted in millions of people having Post-COVID. Post-COVID is a complex, non-monolithic disease with diverse clinical manifestations. Symptoms range from fatigue, brain fog, muscle aches and shortness of breath, affecting multiple organ systems simultaneously. To directly address this multi-organ component of Post-COVID, innovative treatment methods are urgently needed. One potential treatment that we will investigate in our study, is the intervention via the vagus nerve, as the cranial nerve plays a central role in communication between the body and the brain and influences targeted behavior. This innovative approach is based on our clinically relevant findings regarding the effects where acute tVNS increased the level of effort (Neuser et al., 2020; Ferstl et al., 2021), specifically targeting a key symptom of Post-COVID. In the proposed study, the investigators aim to investigate the effectiveness of transcutaneous vagus nerve stimulation (tVNS) as a non-invasive, self-administered treatment for Post-COVID symptoms at home. To evaluate the clinically relevant effects of repeated taVNS application (high-intensity stimulation), the investigators will employ a randomized cross-over design to investigate stimulation-induced changes in fatigue, depression and motivation to work for reward compared to low-intensity stimulation and to a control group.
Detailed description
The proposed study aims to advance the understanding of Post-COVID treatment using a randomized cross-over design to evaluate the taVNS-induced changes over 12 weeks. A hundred twenty patients diagnosed with Long/Post-COVID are randomly assigned to one of three groups related to the two arms of the study ("Monitoring with low/high-intensity stimulation" vs. Monitoring without stimulation"). In the treatment group, forty patients will start with high-intensity taVNS for 6 weeks, then switch to low-intensity stimulation for an additional 6 weeks. Another 40 patients begin with low-intensity stimulation for 6 weeks, followed by high-intensity taVNS stimulation. The control group ("Monitoring without stimulation") is able to receive taVNS after participation in the study.
The treatment group and the control group will participate in the same monitoring procedures. All participants will attend an initial laboratory session to complete several baseline assessments, including questionnaires, measuring energy expenditure via indirect calorimetry and completing a body silhouette task. Blood samples are taken at every session to evaluate changes in metabolic and inflammatory markers. To assess the motivation to work for rewards, the investigators employ an effort-based-cost-benefit paradigm (Effort Allocation Task). All these lab assessments will be repeated after 6 and 12 weeks to evaluate stimulation-induces changes in primary and secondary outcomes. In addition, all participants are given a cardio bracelet to monitor physiological parameters (e.g. heart rate, heart rate variability, breathing, skin conductance, step counts) over the study period. Over the 12 weeks, the treatment group will self-administer taVNS for four hours daily in a targeted manner, anticipating forthcoming exertion and stimulating in anticipation of an effortful event to enhance the patients' motivational drive and recovery. Another essential part of the study is the monitoring over the 12 weeks. All participants will complete daily ecological momentary assessments via smartphone to monitor their mental states. In addition, participants will perform once a day one of two discounting games (effort or temporal discounting task) to investigate changes in their decision behavior over time. The effort discounting task is essential to assess the motivation of post-COVID patients to pursue subjectively effortful situations over the 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monitoring with high/low-intensity stimulation | Experimental | Device: transcutaneous vagus nerve stimulation, Behavioral: Monitoring, Device: cardiowatch braceletThe cross-over design includes one group which starts with high-intensity stimulation (n = 40) and another group, who starts with low-intensity stimulation (n = 40). The first group receives at first high-intensity for 6 weeks, followed by a low-intensity stimulation phase for 6 weeks. To control for placebo effects, other forty individuals start with the 6-week low-intensity stimulation phase followed by 6 weeks of high-intensity tVNS stimulation phase. |
| Monitoring without stimulation | Experimental | Behavioral: Monitoring, Device: cardiowatch braceletAnother group of patients is included as a control group (n = 40) undergoing 'treatment as usual' for Long/Post Covid. This group of participants receive the same monitoring throughout their participation during 12 weeks as the Stimulation-Group. As there is no standardized treatment protocol for Long/Post Covid, 'treatment as usual' implies a supportive approach. This group of participants have the option to receive taVNS stimulation after participating in the study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- individuals who have previously tested positive for SARS-CoV-2 infection (preferred PCR-Test) or have a medically confirmed history of COVID-19 (preferred SARS-CoV-2 Antibody-test) and have persistent symptoms (including Post-COVID) .
- clinical diagnoses made by physician: individuals are included with at least one persistent symptom for at least 4 weeks (Long-COVID) or at least 8 weeks (Post-COVID) following the SARS-CoV-2 infections, such as fatigue, shortness of breath, brain fog, headaches, irritability, cognitive difficulties, muscle or joint pain, sleep disturbances, etc.
- Participants should not have an alternative explanation for their persistent symptoms, ruling out other medical or psychiatric conditions.
Key exclusion criteria (15 listed)
- lack of capacity for consent
- insufficient German language skills: Participants must have sufficient (B2 German) language skills to understand the informed consent form, study procedures, and questionnaires.
- Intensive Care Unit treatment during COVID-19 infection
- BMI > 18.5 \& BMI < 30 kg/m2
- brain injury, stroke, epilepsy, or history of seizures
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 vagus nerve stimulationThe study employs a CE-certified tVNS® E device, ensuring European safety standards (EU regulation 2017/745 on medical devices). This device features a stimulation cycle of 28 seconds on and 32 seconds off, with a 25 Hz impulse frequency. For the high-intensity group, the stimulation intensity will be individually adjusted in the session before starting the high-intensity tVNS stimulation at home. Recommended daily usage is max. 4 hours, after which it automatically shuts off. | Device | Monitoring with high/low-intensity stimulation |
| MonitoringParticipants are monitored over 12 weeks using a combination of questionnaires and ecological momentary assessment. This approach allows for a comprehensive assessment of the patient's health and well-being. | Behavioural | Monitoring with high/low-intensity stimulation, Monitoring without stimulation |
| cardiowatch braceletThe study employs the medically certified cardiowatch bracelet from Corsano (CE-MDR medical certification, FDA 510 (k) cleared) for continuous monitoring of vital signals, such as heart rate, heart rate variability, breathing rate, SpO2, physical activity and sleep. | Device | Monitoring with high/low-intensity stimulation, Monitoring without stimulation |
Primary outcome
Stimulation-induced changes in invigoration: frequency of button presses during the first seconds of the trial to gain monetary rewards in the Effort Allocation Task.
Time frame: Pre treatment vs. after 6-week tVNS vs. after 6-week low-intensity stimulation phase
Changes in invigoration to work for rewards are operationalized as the relative increase in the frequency of button presses on an Xbox controller during the first seconds of the trial in the Effort Allocation Task.
Stimulation-induced changes in symptoms of depression
Time frame: Pre treatment vs. after 6-week tVNS vs. after 6-week low-intensity stimulation phase
Changes in symptoms of depression are measured via the Montgomery Asberg Depression Scale. The MADRS comprises 10 items rated on a scale from 0 to 6 to compute a sum score with higher scores indicating severe symptoms of depression.
Stimulation-induced changes in physical and mental aspects of fatigue
Time frame: Pre treatment vs. after 6-week tVNS vs. after 6-week low-intensity stimulation phase
Changes in fatigue are measured by the Chalder Fatigue scale. The CFS comprises 11 questions rated on a 4-point Likert scale to compute a sum score. It will be measured three times six weeks apart.
13 secondary outcomes
Stimulation-induced changes in heart rate variability
Time frame: during 6-week tVNS compared to during 6-week low-intensity stimulation phase
Stimulation-induced changes in physical activity
Time frame: during 6-week tVNS compared to during 6-week low-intensity stimulation phase
Stimulation-induced changes in wanting the monetary rewards
Time frame: Pre treatment vs. after 6-week tVNS vs. after 6-week low-intensity stimulation phase
Stimulation-induced changes in exertion
Time frame: Pre treatment vs. after 6-week tVNS vs. after 6-week low-intensity stimulation phase
Stimulation-induced changes in the motivation to invest effort: the discounting rate reflecting rewards devalued by effort
Time frame: during 6-week tVNS compared to during 6-week low-intensity stimulation phase
Stimulation-induced changes in metabolic and inflammatory markers
Time frame: Pre treatment vs. after 6-week tVNS vs. after 6-week low-intensity stimulation phase
Stimulation-induced changes in health-related quality of life
Time frame: Pre treatment vs. after 6-week tVNS vs. after 6-week low-intensity stimulation phase
Stimulation-induced changes in mood and mood response to effort
Time frame: Pre treatment vs. after 6-week tVNS vs. after 6-week low-intensity stimulation phase
Stimulation-induced changes in maintenance:the average relative frequency across the complete trial to gain monetary rewards in the Effort Allocation Task.
Time frame: Pre treatment vs. after 6-week tVNS vs. after 6-week low-intensity stimulation phase
Stimulation-induced changes in heart rate
Time frame: during 6-week tVNS compared to during 6-week low-intensity stimulation phase
Stimulation-induced changes in effort utility
Time frame: Pre-treatment vs. after 6-week tVNS vs. after 6-week low-intensity stimulation phase
stimulation-induced changes in self-reported depressive symptoms
Time frame: Pre treatment vs. after 6-week tVNS vs. after 6-week low-intensity stimulation phase
Stimulation-induced changes in HR
Time frame: During 6-week tVNS compared to during 6-week low-intensity stimulation phase
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Statistical Analysis PlanLink provided by the sponsor.
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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.
Nils B. Kroemer, Prof. Dr. principal investigator
Department of Psychiatry & Psychotherapy, University of Tübingen,Tübingen, 72076
Andreas J. Fallgatter, Prof. Dr. principal investigator
Department of Psychiatry & Psychotherapy, University of Tübingen,Tübingen, 72076
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 vagus nerve stimulation, Monitoring and cardiowatch bracelet in people with Post-COVID-19 Syndrome, run by University Hospital Tuebingen at 1 site in Germany.
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 15 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: under way, not looking for participants, as of the sponsor's last update on 9 Sep 2026. 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 Germany. 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?
This study is still under way. Results are not available in the source record yet.
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?
Stimulation-induced changes in invigoration: frequency of button presses during the first seconds of the trial to gain monetary rewards in the Effort Allocation Task. (time frame: Pre treatment vs. after 6-week tVNS vs. after 6-week low-intensity stimulation phase). The study lists 3 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 9 Sep 2026.