The Impact of Neuronavigation in rTMS for Hemiplegic Stroke Patients.

NCT07284017 | Not Yet Recruiting

• 1 other identifier: TCVGH-CF25252C
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Stroke; Hemiparesis After Stroke

Keywords

rTMS; Repetitive Transcranial Magnetic Stimulation; Neuronavigation

Outcome Measures

Primary Outcomes (3)

• 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.

  Baseline (T0), Post-treatment (T1, 2 weeks), and 1 Month Post-treatment (T2)

• 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.

  Intra-session (recorded during each daily treatment session for 2 weeks) and Inter-session (change from baseline to 2 weeks)

• 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.

  Baseline (T0)

Study Arms (2)

Neuronavigation-Guided Low-Frequency rTMS

EXPERIMENTAL

Participants in this arm receive low-frequency rTMS where the coil positioning is guided and recorded by a neuronavigational system during each of the 10 sessions. The system ensures precise targeting of the M1 hotspot contralateral to the lesion.

Device: Neuronavigation-Assisted rTMS for Stroke Hemiparesis

Conventional Positioning Low-Frequency rTMS

ACTIVE COMPARATOR

Participants in this arm receive the same low-frequency rTMS, but the coil positioning is performed via Standard Manual Localization (e.g., using cap positioning) over the M1 hotspot.

Device: Standard Localization rTMS for Stroke Hemiparesis

Interventions

Neuronavigation-Assisted rTMS for Stroke Hemiparesis DEVICE

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.

Neuronavigation-Guided Low-Frequency rTMS

Standard Localization rTMS for Stroke Hemiparesis DEVICE

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.

Conventional Positioning Low-Frequency rTMS

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Taichung Veterans General Hospital: lead

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Ting-Chun Fang, M.D.

CONTACT

+886-965020216; immotalman@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Model Details: This is a two-arm, parallel assignment study where thirty participants with subacute stroke hemiparesis are randomly assigned to one of two groups for intervention. Both groups receive the identical low-frequency rTMS treatment, consisting of ten sessions of 1 Hz stimulation with 1,200 pulses per session, administered over two consecutive weeks. The primary distinction between the arms is the coil localization method: the Experimental Arm utilizes a neuronavigational system to guide and record the precise M1 hotspot positioning during each session, while the Control Arm relies on standard manual localization, such as cap positioning. The study is designed to compare the precision in coil placement and the resulting clinical efficacy of these two methods for motor recovery.

Study Record Dates

• First Submitted: November 30, 2025
• First Posted: December 16, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 16, 2025

Record last verified: 2025-12