Ischemic StrokePhase 1/2TPS-STROKENCT07784751
Safety, Dose-Finding, and Efficacy of Transcranial Pulse Stimulation for Post-Stroke Neurorehabilitation
A Phase 1/2 study testing Required Field in people with Ischemic Stroke, run by Taipei Hospital, Ministry of Health and Welfare at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Required Field
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Aug 2026to 24 Aug 2027
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
- Age 20-80 years old.
- Confirmed ischemic stroke verified by MRI.
- Stroke onset between 1 month and 6 months prior to study enrollment.
- NIHSS score of 4-25 points, with quantifiable motor or language deficits.
- Completed acute medical care with stable vital signs.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Ischemic Stroke
- Being tested
- Required Field
- Keywords
- Transcranial Pulse Stimulation (TPS); Ischemic Stroke; Stroke Rehabilitation; Neurorehabilitation; Dose Escalation
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Required FieldDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 0.15 → 0.20 → 0.25 mJ/mm² | Experimental | Participants will receive transcranial pulse stimulation (TPS) at an energy level of 0.15 mJ/mm², three times per week for 2 weeks, for a total of 6 treatment sessions.
Participants will receive transcranial pulse stimulation (TPS) at an energy level of 0.20 mJ/mm², three times per week for 2 weeks, for a total of 6 treatment sessions.
Participants will receive transcranial pulse stimulation (TPS) at an energy level of 0.25 mJ/mm², three times per week for 2 weeks, for a total of 6 treatment sessions. Receives: Device: Required Field |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, 2 weeks (immediately post-treatment), and 1 month post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start20 Aug 2026
- Primary completion24 Aug 2027 (estimated)
- Study completion24 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Hospital, Ministry of Health and Welfare
- Sponsor type
- University, hospital or other
- Collaborators
- Chang Gung University, National Central University
- Responsible party
- Principal investigator, YEH,YUAN-JUI, Taipei Hospital, Ministry of Health and Welfare
- Investigators
- Director, Department of Physical Medicine and Rehabilitation,, Study director, Taipei Hospital, Ministry of Health and Welfare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07784751
- Sponsor's protocol ID
- TYGH115031
- Acronym
- TPS-STROKE
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will not be publicly shared to protect participant privacy and maintain confidentiality in accordance with institutional review board (IRB) guidelines and local data protection regulations.