NCT06510985Active, not recruiting
Transcutaneous Vagus Nerve Stimulation (tVNS) for Improved Recovery After Exertion.
Transcutaneous Vagus Nerve Stimulation (tVNS) for Improved Recovery After Exertion in Patients With Long/Post-COVID.
Source: ClinicalTrials.gov · Last updated 9 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 17 Jul 2024
- Start date
- Jul 2024
- Primary completion date
- May 2027
- Lead sponsor
- University Hospital Tuebingen
- Diseases
- Long COVID and ME/CFS
- NCT number
- NCT06510985
What you commit to
- Study type: Interventional
- Planned participants: 120
- From Jul 2024 to the primary completion date, May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- active implant (pacemaker, cochlear implant, implanted electrode device) and cerebral shunts
Other illness
- Intensive Care Unit treatment during COVID-19 infection
- brain injury, stroke, epilepsy, or history of seizures
- bipolar disorder
- severe substance use disorders, except tobacco
- cardiac arrhythmia, coronary heart disease
- ear infections, open wounds, or impaired skin at electrode sites
Other
- 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.
- BMI \> 18.5 \& BMI \< 30 kg/m2
- Lifetime (according to DSM 5):
- schizophrenia
- 12-month prevalence: pregnancy or nursing
- Additional exclusion criteria for a safe application of tVNS:
- required permanent use of left-sided hearing aid
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Translational Psychiatry, Department of Psychiatry and Psychotherapy, University Hosptial Tübingen Coordinator of this site? Confirm its status | Tübingen | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.