Status:
RECRUITING
Transcranial Pulse Stimulation (TPS) in Post-COVID-19
Lead Sponsor:
Medical University of Vienna
Conditions:
Post-COVID-19 Syndrome
Fatigue
Eligibility:
All Genders
20-80 years
Phase:
NA
Brief Summary
The objective of the present study is to demonstrate treatment efficacy of transcranial pulse stimulation for patients with Post-COVID-19 related neurological symptoms (fatigue, cognitive deficits, mo...
Detailed Description
This clinical trial aims to investigate the treatment efficacy of transcranial pulse stimulation (TPS) using the NEUROLITH device (Storz Medical AG, Tägerwilen, Switzerland) in individuals with neurol...
Eligibility Criteria
Inclusion
- Signed written informed consent
- PCR-confirmed SARS-CoV-2 infection, laboratory confirmed antibody detection for SARS-CoV-2, or physician-verified COVID-19 infection
- At least 12 months after initial SARS-CoV-2 infection that led to Post-COVID (subsequent SARS-CoV-2 infections are not a reason for exclusion)
- Diagnosis of Post-COVID Syndrome or independent suspected diagnosis of Post-COVID Syndrome (Considering that physicians generally hesitate to provide clear-cut Post-COVID diagnoses, a tentative diagnosis by an independent general practitioner or a specialist in a field associated with Post-COVID will suffice for entering this study)
- Age: 20-80
- Evidence of a negative pregnancy test if medically adequate
Exclusion
- Clinically relevant realization of pre-COVID diseases with similar symptoms as Post-COVID
- MoCA score \<17 (cut-off for dementia)
- BDI-II score ≥29 (cut-off for severe depression)
- FIS \<10 (cut-off for no fatigue)
- Brain implants
- Non-MR-compatible metal parts in the body
- Metal parts in the head
- Use of anticoagulants
- Non-MR-compatible claustrophobia
- Non-MR-compatible pacemaker
- Pregnant and breastfeeding women
- Clinically relevant history of surgery on the head, heart, or vessels
- Relevant corticosteroid treatments administered within 6 weeks prior to the first application
- Tumor of the head if relevant for treatment
- Blood clotting disorders
- Participation in other studies
Key Trial Info
Start Date :
January 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT06178952
Start Date
January 8 2024
End Date
January 1 2027
Last Update
December 23 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Medical University of Vienna
Vienna, Vienna, Austria, 1090