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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Neuronavigation-Assisted rTMS for Stroke Hemiparesis
DeviceLow-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.
Standard Localization rTMS for Stroke Hemiparesis
DeviceLow-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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Neuronavigation-Guided Low-Frequency rTMSExperimental treatment 1 intervention
Group B: Conventional Positioning Low-Frequency rTMSActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Fugl-Meyer Assessment (FMA) Score
The FMA is a quantitative, reliable, and widely used stroke-specific assessment tool for measuring motor recovery. This scale ranges from 0 to 66 points, where a higher score indicates better motor function of the upper limb. The difference in FMA scores between the neuronavigation group and the standard localization group will be compared to evaluate the treatment efficacy.
Time frame
Baseline (T0), Post-treatment (T1, 2 weeks), and 1 Month Post-treatment (T2)2
Deviation in Coil Positioning
This measure quantifies the positional stability and accuracy of the rTMS coil placement. The neuronavigational system records positional coordinates before and after each session in the experimental group. The outcome will compare the intra-session (stability throughout a single treatment) and inter-session (change from baseline to 2 weeks) deviation in coil coordinates between the neuronavigation-guided group and the standard manual localization group.
Time frame
Intra-session (recorded during each daily treatment session for 2 weeks) and Inter-session (change from baseline to 2 weeks)3
Time Required for Initial Hotspot Localization
This outcome measures the time (recorded in seconds or minutes) needed to accurately determine the M1 "hotspot" (the site eliciting the maximal motor-evoked potential (MEP)) at the start of the study. This comparison aims to quantify the efficiency difference between the neuronavigation-guided method and the standard manual localization method.
Time frame
Baseline (T0)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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