The Impact of Neuronavigation in rTMS for Hemiplegic Stroke Patients. (NeurorTMS-HS)

December 14, 2025 updated by: Ting-Chun Fang, Taichung Veterans General Hospital

The Impact of Neuronavigation in Repetitive Transcranial Magnetic Stimulation (rTMS) for Hemiplegic Stroke Patients.

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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:

  1. 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.
  2. 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.
  3. Grouping:

(1)Experimental Group (n=15): Coil positioning will be guided by a neuronavigational system throughout all 10 sessions. The system tracks the coil and patient's head relative to the initial M1 hotspot.

(2)Control Group (n=15): Coil positioning will rely on standard manual localization (e.g., cap positioning).

Outcome Assessments:

The study will track three primary outcomes: FMA score (a key measure of motor function), coil positioning deviation (a measure of precision), and the time required for initial hotspot localization. Secondary outcomes include functional and spasticity measures such as the Barthel Index (BI), Modified Rankin Scale (mRS), Modified Ashworth Scale (mAS), and neurophysiological parameters (MEP, EEG).

Timeline:

All outcome measures will be assessed at three time points: Baseline (T0), Post-treatment (T1, Week 3), and 1-month Follow-up (T2, Week 7).

Safety:

All adverse events, including rare severe events like seizures (<0.01%) and syncope, will be managed according to standard emergency protocols, and treatment will be discontinued if adverse effects persist or significant clinical weakness occurs. The study protocol is within established safety guidelines.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Neuronavigation-Guided Low-Frequency rTMS
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
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.
Active Comparator: Conventional Positioning Low-Frequency rTMS
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (T0), Post-treatment (T1, 2 weeks), and 1 Month Post-treatment (T2)
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.
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
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.
Baseline (T0)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taichung Veterans General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

November 30, 2025

First Submitted That Met QC Criteria

December 14, 2025

First Posted (Actual)

December 16, 2025

Study Record Updates

Last Update Posted (Actual)

December 16, 2025

Last Update Submitted That Met QC Criteria

December 14, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TCVGH-CF25252C

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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