StrokeNeurorTMS-HSNCT07284017
The Impact of Neuronavigation in rTMS for Hemiplegic Stroke Patients.
A study testing Neuronavigation-Assisted rTMS for Stroke Hemiparesis and Standard Localization rTMS for Stroke Hemiparesis in people with Stroke and Hemiparesis After Stroke, run by Taichung Veterans General Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Stroke, Hemiparesis After Stroke
- What is being tested?
- Neuronavigation-Assisted rTMS for Stroke Hemiparesis and Standard Localization rTMS for Stroke Hemiparesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 .
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
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).
Read the 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: (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.
- Conditions
- Stroke, Hemiparesis After Stroke
- Being tested
- Neuronavigation-Assisted rTMS for Stroke Hemiparesis, Standard Localization rTMS for Stroke Hemiparesis
- Keywords
- rTMS, Repetitive Transcranial Magnetic Stimulation, Neuronavigation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuronavigation-Assisted rTMS for Stroke HemiparesisDevice
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.
Standard Localization rTMS for Stroke HemiparesisDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Standard Localization rTMS for Stroke Hemiparesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline (T0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ting-Chun Fang, Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07284017
- Sponsor's protocol ID
- TCVGH-CF25252C
- Acronym
- NeurorTMS-HS
- Status last verified
- Dec 2025
- First submitted
- 30 Nov 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Neuronavigation in Repetitive Transcranial Magnetic Stimulation (rTMS) for Hemiplegic Stroke Patients.
- ClinicalTrials.gov ID
- NCT07284017
- Acronym / sponsor ID
- NeurorTMS-HS / TCVGH-CF25252C
- Conditions
- Stroke, Hemiparesis After Stroke
- Keywords
- rTMS, Repetitive Transcranial Magnetic Stimulation, Neuronavigation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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: (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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Neuronavigation-Guided Low-Frequency rTMS | Experimental | Device: Neuronavigation-Assisted rTMS for Stroke HemiparesisParticipants 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. |
| Conventional Positioning Low-Frequency rTMS | Active comparator | Device: Standard Localization rTMS for Stroke HemiparesisParticipants 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. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuronavigation-Assisted rTMS for Stroke HemiparesisLow-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. | Device | Neuronavigation-Guided Low-Frequency rTMS |
| Standard Localization rTMS for Stroke HemiparesisLow-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. | Device | Conventional Positioning Low-Frequency rTMS |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Neuronavigation-Assisted rTMS for Stroke Hemiparesis and Standard Localization rTMS for Stroke Hemiparesis in people with Stroke and Hemiparesis After Stroke, run by Taichung Veterans General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ting-Chun Fang, M.D. (+886-965020216, immotalman@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fugl-Meyer Assessment (FMA) Score (time frame: Baseline (T0), Post-treatment (T1, 2 weeks), and 1 Month Post-treatment (T2)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.