Study of Transcranial Pulse Stimulation Using the NEUROLITH Device to Treat Post-COVID-19 Neurological Symptoms Including Fatigue

What this Trial Is About

Researchers are evaluating the effectiveness of transcranial pulse stimulation TPS for treating neurological symptoms related to Post-COVID-19, including fatigue, cognitive problems, and mood changes. This study uses a double-blind, randomized, placebo-controlled design to compare the active TPS treatment with a sham placebo procedure. The primary goal is to measure fatigue improvement using the Fatigue Impact Scale FIS. Participants will be randomly assigned to receive either five sessions of active TPS or five sessions of sham TPS over 10 days, with one daily session lasting about 30 minutes. The TPS treatment uses the NEUROLITH device, which delivers non-invasive ultrasound pulses to the brain. The sham treatment mimics the active procedure without delivering pulses. Assessments occur at baseline, shortly after treatment, and one month later, with additional follow-ups planned up to two years to monitor long-term effects. During the study, participants will undergo multiple assessments including fatigue, depression, cognitive function, quality of life, anxiety, and brain imaging at each main time point. The study also collects limited data at later intervals up to 24 months post-treatment. The total active participation period is about 3 to 4 months, with careful monitoring and evaluation of symptoms and treatment effects throughout the trial to understand the impact of TPS on Post-COVID-19 neurological symptoms.

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