Transcutaneous Vagus Nerve Stimulation (tVNS) for Improved Recovery After Exertion.

Launched by UNIVERSITY HOSPITAL TUEBINGEN · Jul 18, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called transcutaneous vagus nerve stimulation (tVNS) to help people recover from Post-COVID-19 Syndrome. Many individuals who have had COVID-19 continue to experience a variety of symptoms like fatigue, brain fog, muscle pain, and shortness of breath even weeks after their infection. The trial aims to see if tVNS, which is a non-invasive method that can be done at home, can improve these symptoms by stimulating the vagus nerve, a key part of the nervous system that helps communicate between the body and the brain.

To participate in the study, individuals must have tested positive for COVID-19 and have persistent symptoms lasting at least four weeks. They should not have other medical conditions that could explain their symptoms, and they need to have a good understanding of German to follow the study instructions. Participants can expect to receive different levels of stimulation during the study to see how it affects their fatigue, mood, and motivation. It's important to note that this trial is not yet recruiting participants, so there is still time to learn more before getting involved.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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 \< 35 kg/m2
• Lifetime (according to DSM 5):
• • brain injury, stroke, epilepsy, or history of seizures
• • 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