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The Impact of Neuronavigation in rTMS for Hemiplegic Stroke Patients.

NCT07284017 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-12-16

No results posted yet for this study

Summary

This is a randomized, controlled trial investigating the efficacy and precision of neuronavigation -guided repetitive transcranial magnetic stimulation (rTMS) for motor recovery in patients with subacute stroke hemiparesis.

The primary goal is to determine if using neuronavigation to precisely target the unaffected primary motor cortex (M1) improves treatment accuracy, efficiency, and clinical outcomes compared to conventional manual positioning.

The study will enroll 30 participants with first-ever stroke onset between 2 weeks and 6 months. Participants will be randomized into two parallel groups: the Experimental Group (neuronavigation-guided rTMS) and the Control Group (conventional positioning rTMS). Both groups will receive the same rTMS parameters: 1 Hz stimulation (low-frequency) over the unaffected M1, 1,200 pulses per session, administered for 10 sessions over 2 consecutive weeks.

Primary outcome measures include the change in the Fugl-Meyer Assessment (FMA) Score for the Upper Extremity and the measurement of coil positioning deviation between sessions. Assessments will be conducted at baseline (T0), post-treatment (T1, Week 3), and one month post-treatment (T2, Week 7). This study is funded in part by a research grant from the Metal Industries Research \& Development Centre (MIRDC).

Conditions

  • Stroke
  • Hemiparesis After Stroke

Interventions

DEVICE

Neuronavigation-Assisted rTMS for Stroke Hemiparesis

Low-frequency (1 Hz) rTMS targeting the M1 "hotspot" contralateral to the lesion, delivered at 80% motor threshold (MT). Each session consists of 1,200 pulses (10 seconds ON, 1 second OFF, repeated 120 cycles). Treatment schedule: 1 session daily, 5 days/week, for 2 consecutive weeks (10 sessions total). Coil positioning is guided by a neuronavigational system using infrared camera and tracking balls.

DEVICE

Standard Localization rTMS for Stroke Hemiparesis

Low-frequency (1 Hz) rTMS targeting the M1 "hotspot" contralateral to the lesion, delivered at 80% MT. Each session consists of 1,200 pulses (10 seconds ON, 1 second OFF, repeated 120 cycles). Treatment schedule: 1 session daily, 5 days/week, for 2 consecutive weeks (10 sessions total). Coil positioning is performed using standard manual localization with cap positioning.

Sponsors & Collaborators

  • Taichung Veterans General Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2026-12-31
Completion
2026-12-31

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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 NCT07284017 on ClinicalTrials.gov