The Impact of Neuronavigation in Repetitive Transcranial Magnetic Stimulation (rTMS) for Hemiplegic Stroke Patients.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 30
- Primary Endpoint
- Change in Fugl-Meyer Assessment (FMA) Score
Study Overview
Brief 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).
Detailed Description
This is a single-center, randomized, two-group parallel-assignment interventional trial conducted at Taichung Veterans General Hospital to compare the effectiveness of neuronavigation-guided rTMS versus conventional rTMS in subacute stroke patients with hemiparesis.
Background: Repetitive Transcranial Magnetic Stimulation (rTMS) is recognized for its potential in stroke rehabilitation, with low-frequency (1 Hz) stimulation over the unaffected motor cortex in the subacute phase rated as Grade A (definitely effective) for upper limb motor recovery. However, the efficacy of rTMS is highly dependent on accurate and consistent coil placement over the target cortical area.
Study Hypothesis: We hypothesize that using neuronavigation-which integrates infrared tracking with brain MRI to establish a precise 3D coordinate reference-will significantly increase the treatment precision, reduce the required localization time, and ultimately lead to superior clinical outcomes compared to conventional manual targeting methods.
Intervention Details:
- Participants: 30 eligible patients (age 20-85) who are 2 weeks to 6 months post-stroke and demonstrate unilateral upper limb weakness will be enrolled.
- Stimulation Parameters: All participants will receive low-frequency rTMS (1 Hz) at 80% of the motor threshold (RMT). Each session consists of 1,200 pulses delivered over approximately 20 minutes.
- Grouping:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
The study is single-blinded. Participants are masked to their group assignment (neuronavigation-guided rTMS versus conventional rTMS). Due to the inherent differences in the physical setup of the intervention, the personnel administering the rTMS treatment (Care Providers/Investigators) cannot be masked. However, the personnel responsible for evaluating the primary and secondary outcomes (Outcomes Assessors) will be masked to the participants' group assignment to ensure objective measurement of the Fugl-Meyer Assessment (FMA) and other clinical scales.
Eligibility Criteria
- Ages
- 20 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
- •Stable vital signs, clear consciousness, and no cognitive impairment.
- •Able to cooperate with assessments and treatment.
- •Written informed consent must be signed by the patient or a legal guardian.
Exclusion Criteria
- •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.
- •Unstable medical conditions affecting participation.
- •Use of certain medications, including benzodiazepines, antidepressants, muscle relaxants (baclofen, tizanidine), or ongoing botulinum toxin injections for post-stroke spasticity.
- •Modified Rankin Scale (mRS) score >=5 .
Outcomes
Primary Outcomes
Change in Fugl-Meyer Assessment (FMA) Score
Time Frame: Baseline (T0), Post-treatment (T1, 2 weeks), and 1 Month Post-treatment (T2)
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.
Deviation in Coil Positioning
Time Frame: Intra-session (recorded during each daily treatment session for 2 weeks) and Inter-session (change from baseline to 2 weeks)
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 Required for Initial Hotspot Localization
Time Frame: Baseline (T0)
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Ting-Chun Fang
Attending Physician
Taichung Veterans General Hospital