Ischemic Stroke
Conditions
Keywords
Transcranial Pulse Stimulation (TPS); Ischemic Stroke; Stroke Rehabilitation; Neurorehabilitation; Dose Escalation
Brief 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.
Detailed description
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.
Interventions
DEVICERequired 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.
Sponsors
Taipei Hospital, Ministry of Health and Welfare
Chang Gung University
National Central University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
This is an open-label study. Neither participants nor study investigators will be masked to the assigned TPS dose level.
Intervention model description
Participants will be assigned to sequential TPS dose levels of 0.15, 0.20, and 0.25 mJ/mm². Three participants will initially be enrolled at each dose level. Dose escalation to the next level will proceed after safety evaluation of the preceding dose level.
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
1. Age 20-80 years old. 2. Confirmed ischemic stroke verified by MRI. 3. Stroke onset between 1 month and 6 months prior to study enrollment. 4. NIHSS score of 4-25 points, with quantifiable motor or language deficits. 5. Completed acute medical care with stable vital signs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Dose-Limiting Toxicity (DLT) and Adverse Events | Baseline, 2 weeks (immediately post-treatment), and 1 month post-treatment | 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). |
Countries
Taiwan
Contacts
STUDY_DIRECTORDirector, Department of Physical Medicine and Rehabilitation,
Taipei Hospital, Ministry of Health and Welfare
Outcome results
None listed