Status:
NOT_YET_RECRUITING
Transcutaneous Vagus Nerve Stimulation (tVNS) for Improved Recovery After Exertion.
Lead Sponsor:
University Hospital Tuebingen
Conditions:
Post-COVID-19 Syndrome
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 fat...
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 diagnos...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06510985
Start Date
July 19 2024
End Date
December 1 2027
Last Update
July 19 2024
Active Locations (1)
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1
Department of Psychiatry & Psychotherapy, University of Tübingen
Tübingen, Baden-Wurttemberg, Germany, 72076