Transcranial Pulse Stimulation (TPS) in Post-COVID-19

Launched by MEDICAL UNIVERSITY OF VIENNA · Dec 20, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a treatment called Transcranial Pulse Stimulation (TPS) to help people who are experiencing ongoing symptoms after recovering from COVID-19, such as fatigue, trouble thinking clearly, and mood changes. The main goal is to see if this treatment can significantly reduce fatigue, which will be measured using a specific scale. Participants will receive either the actual treatment or a placebo (a fake treatment that looks the same) to compare the effects.

To be eligible for this study, participants need to be between 20 to 80 years old, have had a confirmed COVID-19 infection at least a year ago, and show signs of Post-COVID Syndrome. They also need to provide written consent to join the study. People with certain health issues or who are pregnant or breastfeeding cannot participate. If you join the study, you can expect to receive the treatment in a safe environment and have your progress monitored closely. This trial is currently recruiting participants, so it’s an opportunity for those struggling with Post-COVID symptoms to seek potential help.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Signed written informed consent
• • PCR-confirmed SARS-CoV-2 infection or laboratory confirmed antibody detection for SARS-CoV-2
• • 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
• • 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