Safety, Dose-Finding, and Efficacy of Transcranial Pulse Stimulation in Post-Stroke Neurorehabilitation
Safety, Dose-Finding, and Efficacy of Transcranial Pulse Stimulation in Post-Stroke Neurorehabilitation
This study aims to evaluate the safety, tolerability, dose-response, and preliminary efficacy of transcranial pulse stimulation (TPS) for neurorehabilitation in patients with ischemic stroke. Participants will receive TPS at different energy levels in a dose-escalation design. Clinical and neurophysiological assessments will be conducted to evaluate changes in motor function, balance, quality of life, and brain activity.
This is a prospective, interventional, non-randomized, open-label dose-finding study evaluating the safety, tolerability, and preliminary efficacy of transcranial pulse stimulation (TPS) in patients with ischemic stroke.
Participants will receive TPS using the NEUROLITH® TPS system (Storz Medical AG, Switzerland). The study will use a sequential dose-escalation design with three energy levels: 0.15, 0.20, and 0.25 mJ/mm². Each participant will receive TPS three times per week for 2 weeks, for a total of 6 treatment sessions. Each session will deliver 4,000 pulses at a frequency of 4 Hz.
The primary focus of the study is to evaluate the safety and tolerability of different TPS energy levels. Secondary and exploratory assessments will evaluate changes in motor function, balance, activities of daily living, quality of life, and neurophysiological measures. Electroencephalography (EEG) and functional near-infrared spectroscopy (fNIRS) will be used to assess changes in brain activity associated with treatment.
The study plans to enroll 9 participants initially, with 3 participants assigned to each dose level. Dose escalation will proceed after safety evaluation of the preceding dose level. If the predefined safety criteria are met, the study may be expanded to include additional participants.