Transcranial Pulse Stimulation (TPS) in Post-COVID-19
Medical University of Vienna
102 participants
Jan 8, 2024
INTERVENTIONAL
Conditions
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, 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
Inclusion Criteria6
- 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 Criteria16
- 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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Interventions
Participants are slated to undergo a total of five TPS sessions over a 10-day interval. Each stimulation session will endure approximately 30 minutes and will be administered once daily.
Placebo treatment will be performed using the same medical device, handpiece and treatment paradigm as in the verum treatment with one difference: the standoff device at the end of the handpiece. This device is designed to replicate the appearance, feel, and sound of the verum system, while omitting the transmission of any pulses.
Locations(1)
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NCT06178952