Using Transcranial Pulse Stimulation to treat Post-COVID-19 symptoms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the efficacy of transcranial pulse stimulation (TPS) for individuals suffering from neurological symptoms related to Post-COVID-19, such as fatigue and cognitive deficits. The study employs a double-blind, randomized, placebo-controlled design, comparing the effects of active TPS treatment to a sham treatment. Participants will be engaged for 3-4 months, with assessments conducted at multiple time points to evaluate changes in fatigue and other related symptoms. The trial aims to enroll 120 patients across two centers in Austria and Italy.

Why it matters

Who can join: the full rules

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

Where it's running

• Medical University of Vienna
  Vienna, State of Vienna, Austria Recruiting

Study contacts

• Principal investigator: Roland Beisteiner, Prof. — Medical University of Vienna
• Study coordinator: Roland Beisteiner, Prof.
• Email: roland.beisteiner@meduniwien.ac.at
• Phone: +43/(0)1 40400-34080

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.