StrokeNCT06752499
rTMS Combined With Motor Training for the Treatment of Upper Limb Motor Dysfunction in Stroke Patients
A study testing Online stimulation and Offline stimulation in people with Stroke and Upper Extremity Paresis, run by Ruijin Hospital at 3 sites in China.
Trial summary
The goal of this clinical trials is to investigate the effectiveness of online repetitive transcranial magnetic stimulation (rTMS) in enhancing upper limb motor rehabilitation during the subacute and chronic phase of stroke. It will also learn about the safety of online rTMS intervention methods. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Stroke, Upper Extremity Paresis
- What is being tested?
- Online stimulation and Offline stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 3 sitesChina
- Study dates
- 20 Feb 2023to 10 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient is first diagnosed with stroke through neurological examination, CT or MRI scan.
- The vital signs are stable and there is a certain degree of upper limb motor dysfunction.
- The age is between 20 and 80 years old.
- The cognitive ability is not significantly affected and the patient can cooperate with various examinations and assessments, with a MMSE score ≥ 20 points.
- There are no serious complications (such as pneumonia, heart failure, urinary tract infection or malnutrition).
- There is no pathological condition that is a contraindication for TMS in the medical history (for example, patients with metal in the brain, such as aneurysm clips, patients with a cardiac pacemaker, pregnant women, or those with a history of epileptic seizures).
- The patient or guardian agrees to sign the informed consent form.
Who cannot join
- Patients with severe heart, lung, liver, kidney diseases and malignant tumors;
- Those with a history of aphasia, severe cognitive impairment or mental illness;
- Patients who have had a history of epileptic seizures in the last month or are taking anti-epileptic drugs recently;
- Those with severe visual or hearing impairments, unable to communicate normally;
- People with metal implants, pacemakers, skull defects or other conditions that prevent them from undergoing TMS.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Shanghai Ruijin Hospital, affiliated to Shanghai Jiao Tong University, School of medicine
Shanghai, Shanghai Municipality, 200025
Shanghai Yang Zhi Rehabilitation Hospital
Shanghai, Songjiang
Changhai Hospital
Shanghai, Yangpu
About this study
The goal of this clinical trials is to investigate the effectiveness of online repetitive transcranial magnetic stimulation (rTMS) in enhancing upper limb motor rehabilitation during the subacute and chronic phase of stroke. It will also learn about the safety of online rTMS intervention methods. The main questions it aims to answer are:
- Does rTMS combined with motor training improve motor rehabilitation in patients？
- Does repetitive transcranial magnetic stimulation (rTMS) combined with motor training enhance the upper limb motor rehabilitation ability in stroke patients by strengthening the functional coupling of the motor circuit to achieve functional reorganization of the brain network ?
Read more
Researchers will compare online rTMS to offline and sham stimulation in stroke patients to see if online rTMS works to alleviate motor dysfunction in multicenter multicenter, blinded and controlled trial.
Participants will:
- randomized to one group(online, offline or sham);
- receive rTMS treatment for 10 days, with 5 working days per week for a total of two weeks;
- receive magnetic resonance imaging (MRI) and electroencephalogram (EEG) evaluations before and after the entire treatment;
- conduct scales and MEP assessment one day before the treatment, as well as one day, one month, and three months after the treatment.
Read the detailed description
In this study, patients were be randomly assigned to three groups: online, offline and sham groups. if patients were able to induce MEPs, intensity of TMS will be 80% RMT; if not , inensity of TMS will be 70%~80% of TMS output.
Patients were stimulated over 2 week period, 4 sessions of tasks were performed everyday. The patient will undergo a 2-week (10-day) stimulation protocol, with fourty tasks performed daily. This includes one session of 10 baseline tasks measurement and three sessions of 5 Hz rTMS synchronized with 10 motor tasks. rTMS will be applied to the ipsilesional motor cortex.
- Conditions
- Stroke, Upper Extremity Paresis
- Being tested
- Online stimulation, Offline stimulation, Sham stimulation
- Keywords
- Repetitive Transcranial Magnetic Stimulation, Upper Limb Motor Dysfunction, online, motor task training, individualized, Motor evoked potentials
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online stimulationDevice
5 Hz rTMS is applied to the primary motor cortex on the affected hemisphere when the patients are performing motor tasks.
Offline stimulationDevice
After 5 Hz rTMS is applied to the primary motor cortex on the affected hemisphere, the patients perform motor tasks.
Sham stimulationDevice
Sham rTMS is applied to the primary motor cortex on the affected hemisphere when the patients are performing motor tasks.
| Study group | Role | What they receive |
|---|---|---|
| Online stimulation | Experimental | 5 Hz rTMS is applied to the primary motor cortex on the affected hemisphere when the patients are performing motor tasks. Receives: Device: Online stimulation |
| Offline stimulation | Active comparator | After 5 Hz rTMS is applied to the primary motor cortex on the affected hemisphere, the patients perform motor tasks. Receives: Device: Offline stimulation |
| Sham stimulation | Sham comparator | Sham rTMS is applied to the primary motor cortex on the affected hemisphere when the patients are performing motor tasks. Receives: Device: Sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in FM-UE From Baseline
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment.
The Fugl-Meyer Assessment - Upper Extremity (FMA-UE) is the upper limb motor domain includes items assessing movement, coordination, and reflex action of the shoulder, elbow, forearm, wrist, hand. It ranges from 0 (hemiplegia) to 66 points (normal motor performance).
FM-UE scale was assessed by site raters who were masked to the intervention).
Measured: Before intervention (day0); After intervention (day15); Follow-up 1 (day45); Follow-up 2 (day105)
Secondary outcomes (8)
Mean Change in ARAT score from Baseline
The Action Research Arm Test (ARAT) is a 19 item observational measure used by physical therapists and other health care professionals to assess upper extremity performance (coordination, dexterity and functioning) in stroke recovery, brain injury and multiple sclerosis populations. The ARAT was originally described by Lyle in 1981 as a modified version of the Upper Extremity Function Test and was used to examine upper limb functional recovery post damage to the cortex.
ARAT score was assessed by site raters who were masked to the intervention.
Measured: Before intervention (day0); After intervention (day15); Follow-up 1 (day45); Follow-up 2 (day105)
Mean Change in WMFT score from Baseline
The WMFT is used to assess the upper limb motor function of patients and serves as an effective supplement to the FMA-UE. By timing single-joint movements, multi-joint movements, and functional activities, as well as evaluating movement quality and speed, it can quantitatively assess the upper limb motor ability of stroke patients. It is more sensitive to patients with mild to moderate stroke, and its grading is relatively detailed, which can sensitively reflect the subtle changes in patients' motor function during evaluation.
The WMFT consists of 15 items, among which items 1-6 are simple joint movements, and items 7-15 are complex functional actions. This scale can not only evaluate impairments but also assess the effect of training on disabilities. The WMFT has good validity and reliability and can be used to evaluate the upper limb function of stroke patients.
WMFT score was assessed by site raters who were masked to the intervention.
Measured: Before intervention (day0); After intervention (day15); Follow-up 1 (day45); Follow-up 2 (day105)
Mean Change in MBI score from Baseline
The Barthel Index for activities of daily living was introduced in 1965 by Barthel and Mahoney to be used in the assessment of the degree of assistance required by patients with stroke (other neuromuscular or musculoskeletal disorders or oncology patients) with regards to 10 items of mobility and self-care (ADL).
MBI score was assessed by site raters who were masked to the intervention.
Measured: Before intervention (day0); After intervention (day15); Follow-up 1 (day45); Follow-up 2 (day105)
Mean Change in PSQI score from Baseline
The Pittsburgh Sleep Quality Index (PSQI) is a widely used self-report questionnaire that assesses sleep quality over a one-month time interval.
The PSQI is commonly used in both clinical and research settings to evaluate various aspects of sleep. It is a valuable tool for assessing sleep quality as it captures multiple dimensions of sleep, including both subjective experiences and objective parameters. It allows researchers and healthcare providers alike to obtain a comprehensive understanding of an individual's sleep patterns and disturbances and inform treatment decisions and interventions for sleep disorders.
PSQI score was assessed by site raters who were masked to the intervention).
Measured: Before intervention (day0); After intervention (day15); Follow-up 1 (day45); Follow-up 2 (day105)
Motor Evoked Potential (MEP) - Resting Motor Threshold (RMT)
Resting motor threshold is an objective measure of cortical excitability. Numerous studies indicate that the success of motor recovery after stroke is significantly determined by the direction and extent of cortical excitability changes.
Measured: Before intervention (day 0); In the middle of intervention (day 6); After intervention (day15); Follow-up 1 (day 45); Follow-up 2 (day105)
MRI changes
multi-modal MRI scanned, including structural MRI, resting-fMRI, task-fMRI, and DTI
Measured: Before intervention (day 0); After intervention (day15)
The average completion time for baseline tasks
The average completion time for baseline tasks refers to the time (seconds) taken by the patient to complete the baseline motor task before each intervention.
Measured: Before intervention (Week 0); Middle of intervention (Week 1); After intervention (Week 2)
Adverse events
adverse events such as headache, sleep disturbance, etc
Measured: Before intervention (day 0); In the middle of intervention (day 6); After intervention (day15)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2024
- Study start20 Feb 2023
- Primary completion10 Sep 2025
- Study completion10 Sep 2025
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 Ruijin 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Changhai Hospital, Shanghai Sunshine Rehabilitation Center, shanghai center for brain science and brain-inspired technology
- Responsible party
- Principal investigator, Qing Xie, PhD, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06752499
- Sponsor's protocol ID
- 2022361
- Status last verified
- Apr 2026
- First submitted
- 27 Dec 2024
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This study plans to share individual participant data with qualified researchers under specific conditions. Please refer to https://zenodo.org/records/17345584
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- rTMS Combined With Motor Training for the Treatment of Upper Limb Motor Dysfunction in Stroke Patients
- ClinicalTrials.gov ID
- NCT06752499
- Acronym / sponsor ID
- 2022361
- Conditions
- Stroke, Upper Extremity Paresis
- Keywords
- Repetitive Transcranial Magnetic Stimulation, Upper Limb Motor Dysfunction, online, motor task training, individualized, Motor evoked potentials
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- Changhai Hospital, Shanghai Sunshine Rehabilitation Center, shanghai center for brain science and brain-inspired technology
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 10 Sep 2025 (actual)
- Study completion
- 10 Sep 2025 (actual)
- First posted
- 30 Dec 2024 (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.
The goal of this clinical trials is to investigate the effectiveness of online repetitive transcranial magnetic stimulation (rTMS) in enhancing upper limb motor rehabilitation during the subacute and chronic phase of stroke. It will also learn about the safety of online rTMS intervention methods. The main questions it aims to answer are:
- Does rTMS combined with motor training improve motor rehabilitation in patients？
- Does repetitive transcranial magnetic stimulation (rTMS) combined with motor training enhance the upper limb motor rehabilitation ability in stroke patients by strengthening the functional coupling of the motor circuit to achieve functional reorganization of the brain network ?
Researchers will compare online rTMS to offline and sham stimulation in stroke patients to see if online rTMS works to alleviate motor dysfunction in multicenter multicenter, blinded and controlled trial.
Participants will:
- randomized to one group(online, offline or sham);
- receive rTMS treatment for 10 days, with 5 working days per week for a total of two weeks;
- receive magnetic resonance imaging (MRI) and electroencephalogram (EEG) evaluations before and after the entire treatment;
- conduct scales and MEP assessment one day before the treatment, as well as one day, one month, and three months after the treatment.
Detailed description
In this study, patients were be randomly assigned to three groups: online, offline and sham groups. if patients were able to induce MEPs, intensity of TMS will be 80% RMT; if not , inensity of TMS will be 70%~80% of TMS output.
Patients were stimulated over 2 week period, 4 sessions of tasks were performed everyday. The patient will undergo a 2-week (10-day) stimulation protocol, with fourty tasks performed daily. This includes one session of 10 baseline tasks measurement and three sessions of 5 Hz rTMS synchronized with 10 motor tasks. rTMS will be applied to the ipsilesional motor cortex.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Online stimulation | Experimental | Device: Online stimulation5 Hz rTMS is applied to the primary motor cortex on the affected hemisphere when the patients are performing motor tasks. |
| Offline stimulation | Active comparator | Device: Offline stimulationAfter 5 Hz rTMS is applied to the primary motor cortex on the affected hemisphere, the patients perform motor tasks. |
| Sham stimulation | Sham comparator | Device: Sham stimulationSham rTMS is applied to the primary motor cortex on the affected hemisphere when the patients are performing motor tasks. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The patient is first diagnosed with stroke through neurological examination, CT or MRI scan.
- The vital signs are stable and there is a certain degree of upper limb motor dysfunction.
- The age is between 20 and 80 years old.
- The cognitive ability is not significantly affected and the patient can cooperate with various examinations and assessments, with a MMSE score ≥ 20 points.
- There are no serious complications (such as pneumonia, heart failure, urinary tract infection or malnutrition).
Key exclusion criteria (5 listed)
- Patients with severe heart, lung, liver, kidney diseases and malignant tumors;
- Those with a history of aphasia, severe cognitive impairment or mental illness;
- Patients who have had a history of epileptic seizures in the last month or are taking anti-epileptic drugs recently;
- Those with severe visual or hearing impairments, unable to communicate normally;
- People with metal implants, pacemakers, skull defects or other conditions that prevent them from undergoing TMS.
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 |
|---|---|---|
| Online stimulation5 Hz rTMS is applied to the primary motor cortex on the affected hemisphere when the patients are performing motor tasks. | Device | Online stimulation |
| Offline stimulationAfter 5 Hz rTMS is applied to the primary motor cortex on the affected hemisphere, the patients perform motor tasks. | Device | Offline stimulation |
| Sham stimulationSham rTMS is applied to the primary motor cortex on the affected hemisphere when the patients are performing motor tasks. | Device | Sham stimulation |
Primary outcome
Mean Change in FM-UE From Baseline
Time frame: Before intervention (day0); After intervention (day15); Follow-up 1 (day45); Follow-up 2 (day105)
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment. The Fugl-Meyer Assessment - Upper Extremity (FMA-UE) is the upper limb motor domain includes items assessing movement, coordination, and reflex action of the shoulder, elbow, forearm, wrist, hand. It ranges from 0 (hemiplegia) to 66 points (normal motor performance). FM-UE scale was assessed by site raters who were masked to the intervention).
8 secondary outcomes
Mean Change in ARAT score from Baseline
Time frame: Before intervention (day0); After intervention (day15); Follow-up 1 (day45); Follow-up 2 (day105)
Mean Change in WMFT score from Baseline
Time frame: Before intervention (day0); After intervention (day15); Follow-up 1 (day45); Follow-up 2 (day105)
Mean Change in MBI score from Baseline
Time frame: Before intervention (day0); After intervention (day15); Follow-up 1 (day45); Follow-up 2 (day105)
Mean Change in PSQI score from Baseline
Time frame: Before intervention (day0); After intervention (day15); Follow-up 1 (day45); Follow-up 2 (day105)
Motor Evoked Potential (MEP) - Resting Motor Threshold (RMT)
Time frame: Before intervention (day 0); In the middle of intervention (day 6); After intervention (day15); Follow-up 1 (day 45); Follow-up 2 (day105)
MRI changes
Time frame: Before intervention (day 0); After intervention (day15)
The average completion time for baseline tasks
Time frame: Before intervention (Week 0); Middle of intervention (Week 1); After intervention (Week 2)
Adverse events
Time frame: Before intervention (day 0); In the middle of intervention (day 6); After intervention (day15)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: Yes. This study plans to share individual participant data with qualified researchers under specific conditions. Please refer to https://zenodo.org/records/17345584
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online stimulation and Offline stimulation in people with Stroke and Upper Extremity Paresis, run by Ruijin Hospital at 3 sites in China.
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 5 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: finished, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change in FM-UE From Baseline (time frame: Before intervention (day0); After intervention (day15); Follow-up 1 (day45); Follow-up 2 (day105)). 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 30 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.