The Impact of Neuronavigation in rTMS for Hemiplegic Stroke Patients.

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-85
SponsorTaichung Veterans General Hospital

About this trial

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).

Eligibility criteria

Qualifiers

First-ever ischemic or hemorrhagic stroke confirmed by imaging.

Stroke causing unilateral upper limb weakness (MRC grade <=3)

Stroke onset must be between 2 weeks and 6 months prior to enrollment (subacute phase).

Age between 20 and 85 years old.

Disqualifiers

Contraindications to TMS (e.g., metallic implants in head, pacemaker, cochlear implant).

History of epilepsy or seizures.

Pregnancy.

Severe cognitive or communication disorders, or inability to give informed consent.

Trial design

Treatments tested in this trial

  • Neuronavigation-Assisted rTMS for Stroke Hemiparesis
  • Standard Localization rTMS for Stroke Hemiparesis

Treatment groups

30 Participants
are divided into 2 treatment groups

Locations

This trial has no locations