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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Participants will receive transcranial pulse stimulation (TPS) using the NEUROLITH® TPS system (Storz Medical AG, Switzerland). TPS will be administered at the assigned energy level of 0.15, 0.20, or 0.25 mJ/mm², at a frequency of 4 Hz, with 4,000 pulses per session. Treatment will be administered three times per week for 2 weeks, for a total of 6 treatment sessions. Dose escalation will proceed sequentially after safety evaluation of the preceding dose level.
Huan-Jui
Taipei, Taiwan, Taiwan
Incidence of Dose-Limiting Toxicity (DLT) and Adverse Events
Safety monitoring including adverse events (AEs), serious adverse events (SAEs), and DLT defined as: NIHSS increase ≥4 points lasting ≥24-48 hours, new-onset seizure, new or worsening neurological deficits, intolerable persistent AEs (headache, dizziness, nausea), or acute MRI worsening (new DWI stroke, hemorrhage, or severe edema).
Time frame: Baseline, 2 weeks (immediately post-treatment), and 1 month post-treatment
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