💬In plain words
What the trial is, and whether it could suit you
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, mood deterioration). Fatigue, as measured by the Fatigue Impact Scale (FIS), will represent the primary outcome variable. The verum treatment will be compared to a sham (placebo) condition.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
* 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 Criteria:
* 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
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