U08.9 U09.9 U10.9 G93.3
Conditions
Interventions
Group 1: Above-threshold-stimulation left tragus
Group 2: Sub-threshold-stimulation left tragus
Group 3: Sham-stimulation left tragus
Group 4: Optional: Participants from Arm 2 and Arm 3 are permitted
Sponsors
Universitätsklinik Knappschaftskrankenhaus Bochum
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Z.n. completed Covid infection within the last 18 months - Fatigue persisting for = 3 months with a score =4 on the FSS fatigue scale - Age >18 - No depression or depression that has been treated stably for 4 weeks
Exclusion criteria
Exclusion criteria: - Serious psychiatric illness such as schizophrenia - Acute corona infection - >8 items on the NGASR suicide questionnaire - Vagus nerve stimulation or condition vagotomy - Relevant cardiac disease: bradycardiac cardiac arrhythmia (e.g. sick sinus syndrome), cardiac insufficiency, status post. Heart attack - Active implant such as cardiac pacemaker, defibrillator, neurostimulator, cochlear implant or drug delivery device and ventricular shunt. - Inability to understand the study - Progressive neurological disease (e.g. Parkinson's, MS, epilepsy) - pregnancy - Other acute illness associated with fatigue (e.g. cancer, chemotherapy, autoimmune diseases) - Polyneuropathy - Presence of a skin condition such as infection, psoriasis or eczema in the treatment area. - Presence of any anatomical abnormality that prevents the successful insertion of the ear electrode. - Presence of any serious medical condition that prevents successful participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acceptance of the therapy, effect of taVNS on MFI-20-Score | — |
Secondary
| Measure | Time frame |
|---|---|
| Effect of taVNS on BDI and SF36 score | — |
Countries
Germany
Contacts
Public ContactMortimer Gierthmühlen
Universitätsklinik Knappschaftskrankenhaus Bochum
Outcome results
None listed