Safety, Dose-Finding, and Efficacy of Transcranial Pulse Stimulation for Post-Stroke Neurorehabilitation

NCT07784751 | Enrolling By Invitation Phase 1 DMC

• 1 other identifier: TYGH115031
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke

Keywords

Transcranial Pulse Stimulation (TPS); Ischemic Stroke; Stroke Rehabilitation; Neurorehabilitation; Dose Escalation

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline, 2 weeks (immediately post-treatment), and 1 month post-treatment

Study Arms (1)

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.

Device: Required Field

Interventions

Required Field DEVICE

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.

0.15 → 0.20 → 0.25 mJ/mm²

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Taipei Hospital, Ministry of Health and Welfare: lead
• Chang Gung University: collaborator
• National Central University: collaborator

Study Sites (1)

Huan-Jui

Taipei, Taiwan, 24213, Taiwan

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Director, Department of Physical Medicine and Rehabilitation,

  Taipei Hospital, Ministry of Health and Welfare

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: This is an open-label study. Neither participants nor study investigators will be masked to the assigned TPS dose level.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Department of Physical Medicine and Rehabilitation

Model Details: 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.

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: August 25, 2026
• Study Start: August 20, 2026
• Primary Completion (Estimated): August 24, 2027
• Study Completion (Estimated): August 24, 2027
• Last Updated: August 25, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Start Date: August 24, 2026. End Date: August 24, 2027 . For one year.
• Access Criteria: Inclusion Criteria 1. Age 20-80 years. 2. Confirmed ischemic stroke, supported by imaging (MRI). 3. Stroke time between: subacute phase: more than 1 month to within 6 months of onset. 4. NIHSS score 4-25, with objectively assessable motor or speech deficits. (Assessment at the time of consent signing) 5. Acute phase medical treatment completed, vital signs stable.

Locations

TW (1)