Vagus Nerve Stimulation for Long/Post-COVID Recovery
This study aims to assess whether stimulating your vagus nerve can help improve your energy levels, reduce fatigue, and alleviate symptoms of depression if you're recovering from long or post-COVID conditions.
transcutaneous vagus nerve stimulation
+ Monitoring
+ cardiowatch bracelet
COVID-19+17
+ Post-Acute COVID-19 Syndrome
+ Post-Infectious Disorders
Treatment Study
Summary
Study start date: July 19, 2024
Actual date on which the first participant was enrolled.This study explores ways to help patients with Long/Post-COVID recover better after physical activity. It focuses on a treatment called transcutaneous vagus nerve stimulation (tVNS), which involves stimulating a nerve in the body using a device. The study involves 120 patients, who are divided into groups to receive either high or low-intensity stimulation, or no stimulation at all. The goal is to see if tVNS can improve recovery and motivation in patients, potentially offering a new method to manage Long/Post-COVID symptoms. Participants in the study will undergo several assessments, including completing questionnaires and providing blood samples to measure various health markers. They will also wear a cardio bracelet to track physiological signs like heart rate and activity levels. Over a 12-week period, those in the treatment group will self-administer tVNS for four hours each day. The study will monitor changes in motivation and decision-making through daily tasks and smartphone assessments. This research is designed to observe how tVNS might influence recovery and mental states in patients dealing with Long/Post-COVID.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.120 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Department of Psychiatry & Psychotherapy, University of Tübingen
Tübingen, GermanyOpen Department of Psychiatry & Psychotherapy, University of Tübingen in Google Maps