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Safety, Dose-Finding, and Efficacy of Transcranial Pulse Stimulation for Post-Stroke Neurorehabilitation
Sponsor: Taipei Hospital, Ministry of Health and Welfare
Summary
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.
Official title: Safety, Dose-Finding, and Efficacy of Transcranial Pulse Stimulation in Post-Stroke Neurorehabilitation
Key Details
Gender
All
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
9
Start Date
2026-08-20
Completion Date
2027-08-24
Last Updated
2026-08-25
Healthy Volunteers
Yes
Conditions
Interventions
Required Field
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.
Locations (1)
Huan-Jui
Taipei, Taiwan, Taiwan