NCT06178952 Transcranial Pulse Stimulation (TPS) in Post-COVID-19
| NCT ID | NCT06178952 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University of Vienna |
| Condition | Post-COVID-19 Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 102 participants |
| Start Date | 2024-01-08 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 102 participants in total. It began in 2024-01-08 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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, 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
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
Contact & Investigator
Roland Beisteiner, Prof.
PRINCIPAL INVESTIGATOR
Medical University of Vienna
Frequently Asked Questions
Who can join the NCT06178952 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 80 Years, studying Post-COVID-19 Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06178952 currently recruiting?
Yes, NCT06178952 is actively recruiting participants. Contact the research team at roland.beisteiner@meduniwien.ac.at for enrollment information.
Where is the NCT06178952 trial being conducted?
This trial is being conducted at Vienna, Austria.
Who is sponsoring the NCT06178952 clinical trial?
NCT06178952 is sponsored by Medical University of Vienna. The principal investigator is Roland Beisteiner, Prof. at Medical University of Vienna. The trial plans to enroll 102 participants.
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