Transcranial Pulse Stimulation (TPS) in Post-COVID-19
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-80
SponsorMedical University of Vienna
About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Transcranial pulse stimulation Verum
- Transcranial pulse stimulation Sham
Treatment groups
102 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov