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

NCT07784751 · Status: ENROLLING_BY_INVITATION · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2026-08-25

No results posted yet for this study

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

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Chang Gung University

    collaborator OTHER

  • National Central University

    collaborator OTHER

  • Taipei Hospital, Ministry of Health and Welfare

    lead OTHER

Principal Investigators

  • Director, Department of Physical Medicine and Rehabilitation, · Taipei Hospital, Ministry of Health and Welfare

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-08-20
Primary Completion
2027-08-24
Completion
2027-08-24

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07784751 on ClinicalTrials.gov