Using Transcranial Pulse Stimulation to treat Post-COVID-19 symptoms
Transcranial Pulse Stimulation (TPS) in Post-COVID-19
This study is testing if a new brain stimulation treatment can help people with lingering neurological symptoms after COVID-19, like fatigue and memory issues.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 102 (estimated) |
| Ages | 20 Years to 80 Years |
| Sex | All |
| Sponsor | Medical University of Vienna Academic / other |
| Locations | 1 site (Vienna, State of Vienna) |
| Trial ID | NCT06178952 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 20-80 who have experienced Post-COVID-19 symptoms for at least 12 months following a confirmed SARS-CoV-2 infection.
Not a fit: Patients with severe pre-existing conditions that mimic Post-COVID symptoms or those with significant cognitive impairment or depression may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly alleviate fatigue and improve cognitive function in patients suffering from Post-COVID-19 syndrome.
How similar studies have performed: While TPS is a novel approach, previous studies on non-invasive brain stimulation have shown promising results in treating various neurological conditions.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Vienna, State of Vienna
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.