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Clinical Trials in Austria / NCT06178952
Recruiting Not applicable

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

NCT06178952 · tracked via the Priya Life Science Austria tracker
Sponsor
Medical University of Vienna
Phase
Not applicable
Started
2024-01-08
Last updated
2025-12-23

Condition(s) studied

Post-COVID-19 SyndromeFatigue

Investigational drug(s) / intervention(s)

Transcranial pulse stimulation VerumTranscranial pulse stimulation Sham

Transcranial pulse stimulation Verum: 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.

Transcranial pulse stimulation Sham: 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.

Study 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

Sex
ALL
Min age
20 Years
Max age
80 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Fatigue Impact Scale (FIS) — Baseline - 1 week after stimulation - 1 month after stimulation
    The Fatigue Impact Scale (Fisk et al., 1994) is an instrument to measure the impact of fatigue symptoms. This self-report measure consists of 40 items divided into three subscales: cognitive functioning (10 items), physical functioning (10 items) and psychosocial functioning (20 items). In the validated German version, the statements are scored from 0-4 (0=never, 4=very often) leading to a total score of 0-160.

Trial sites (1)

FacilityCityRegionStatus
Medical University of Vienna Vienna State of Vienna Recruiting

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Other trials for the same condition

Effects of a Home-Based Exercise Intervention in Subjects with Long COVID Active, not recruiting
Retinal Neurovascular Coupling in Patients Previously Infected With COVID-19 Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06178952 on ClinicalTrials.gov ↗ ← All trials in Austria