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AzTrials

Upper Extremity Dysfunction After the StrokerTMSNCT07049211

Individualized rTMS Synchronized Task Training for Closed-loop Neuromodulation of Post-stroke Motor Dysfunction

A study testing Individualized online stimulation and Non-individualized online stimulation in people with Upper Extremity Dysfunction After the Stroke, run by Ruijin Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

The goal of this clinical trials is to investigate the effectiveness of individualized 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
What is being tested?
Individualized online stimulation and Non-individualized online stimulation
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
51 participants
Where
1 siteChina
Study dates
20 Jul 2025to 20 May 2028
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 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.
  • Motor evoked potentials(MEPs) of First Dorsal Interosseous Muscle(FDI)or Abductor Pollicis Brevis Muscle (APB) is negative in ipsilesional hemisphere.
  • 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

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yang LIU, Master of Medicine contact

+8615821650228

ly12446@rjh.com.cn

China1 site
  • Shanghai Ruijin Hospital, affiliated to Shanghai Jiao Tong University, School of medicine

    Shanghai, Shanghai Municipality, 200025

    Yifeng WANG, +8602154661789, wyf30456@rjh.com.cn

Other trials in China

About this study

Official title: Individualized Closed-Loop Neuromodulation With Repetitive Transcranial Magnetic Stimulation Synchronized Task Training for Upper Limb Motor Dysfunction in Stroke Patients

The goal of this clinical trials is to investigate the effectiveness of individualized 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:

  1. Does individualized rTMS precise target combined with motor training improve upper limb motor rehabilitation in patients?
  2. Does individualized rTMS precise target 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 individualized online rTMS to non-individualized online and individualized sham stimulation in stroke patients to see if individualized online rTMS works to alleviate motor dysfunction in this randomized,sham-controlled, double-blind trial.

Participants will:

  1. randomized to one group(individualized online, non-individualized online or sham);
  2. receive rTMS treatment for 10 days, with 5 working days per week for a total of two weeks;
  3. receive magnetic resonance imaging (MRI) and electroencephalogram (EEG) evaluations before and after the entire treatment;
  4. conduct scales and MEP assessment one day before the treatment, as well as one day, one month, and three months after the treatment.
Being tested
Individualized online stimulation, Non-individualized online stimulation, Sham stimulation
Keywords
repetitive transcranial magnetic stimulaiton, stroke, online, individualized, upper limb motor dysfunction
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Individualized online stimulationDevice

    The individualized online stimulation group will calculate precise targets based on the collected multimodal MRI (structural images, resting-state/task-state functional images, and diffusion tensor imaging), plan the coil position and placement angle of TMS through electric field simulation, and achieve individualized intervention. At the same time, when patients receive TMS treatment, they are matched with specific upper limb motor tasks. When the task starts autonomously, TMS stimulation is triggered by acceleration-EMG feedback. When the task stops or is completed, TMS stimulation also stops immediately according to the acceleration-EMG feedback to achieve real-time effects.

  • Non-individualized online stimulationDevice

    In the non-individualized online stimulation group, patients receive TMS treatment synchronized with task training. However, the targeting uses traditional positioning methods, i.e., determining the target with a positioning cap instead of precise target localization.

  • Sham stimulationDevice

    In the individualized online sham stimulation group, patients receive TMS treatment combined with specific tasks. The stimulation targets are the same as those in the online stimulation group, all determined by precise target localization, except that a sham stimulation coil is used for TMS stimulation.

Study groups in NCT07049211
Study groupRoleWhat they receive
Individualized online stimulationExperimentalThe individualized online stimulation group will calculate precise targets based on the collected multimodal MRI (structural images, resting-state/task-state functional images, and diffusion tensor imaging), plan the coil position and placement angle of TMS through electric field simulation, and achieve individualized intervention. At the same time, when patients receive TMS treatment, they are paired with specific upper limb motor tasks. When the task starts autonomously, TMS stimulation is triggered by acceleration-EMG feedback. When the task stops or is completed, TMS stimulation also stops immediately according to the acceleration-EMG feedback to achieve real-time effects.
Receives: Device: Individualized online stimulation
Non-individualized online stimulationActive comparatorIn the non-individualized online stimulation group, patients receive TMS treatment synchronized with task training. However, the targeting uses traditional positioning methods, i.e., determining the target with a positioning cap instead of precise target localization.
Receives: Device: Non-individualized online stimulation
Sham stimulationSham comparatorIn the individualized online sham stimulation group, patients receive TMS treatment combined with specific tasks. The stimulation targets are the same as those in the online stimulation group, all determined by precise target localization, except that a sham stimulation coil is used for TMS stimulation.
Receives: Device: Sham stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fugl-Meyer Assessment - Upper Extremity (FMA-UE)

    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).

    Measured: Baseline; Day 1 After 2-week intervention; Day 30 after 2-week intervention; Day 90 after 2-week intervention

Secondary outcomes (5)
  1. Action Research Arm Test (ARAT)

    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.

    Measured: Baseline; Day 1 After 2-week intervention; Day 30 after 2-week intervention; Day 90 after 2-week intervention

  2. Modified Barthel Index (MBI)

    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).

    Measured: Baseline; Day 1 After 2-week intervention; Day 30 after 2-week intervention; Day 90 after 2-week intervention

  3. The Pittsburgh Sleep Quality Index (PSQI)

    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.

    Measured: Baseline; Day 1 After 2-week intervention; Day 30 after 2-week intervention; Day 90 after 2-week intervention

  4. 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: Baseline; Day 6 during 2-week intervention; Day 1 After 2-week intervention; Day 30 after 2-week intervention; Day 90 after 2-week intervention

  5. 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: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day7, Day 8, Day 9, Day 10 during TMS intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jul 2025
  2. Study start20 Jul 2025 (estimated)
  3. Primary completion20 Jan 2028 (estimated)
  4. Study completion20 May 2028 (estimated)

Resources

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
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
51 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07049211
Sponsor's protocol ID
2025296
Acronym
rTMS
Status last verified
May 2025
First submitted
16 Jun 2025
Last updated
3 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: We will share the demographic information and baseline clinical data of all participants.

Publications

  • Khedr EM, Etraby AE, Hemeda M, Nasef AM, Razek AA. Long-term effect of repetitive transcranial magnetic stimulation on motor function recovery after acute ischemic stroke. Acta Neurol Scand. 2010 Jan;121(1):30-7. doi: 10.1111/j.1600-0404.2009.01195.x. Epub 2009 Aug 11.

    PubMed 19678808
  • Ackerley SJ, Stinear CM, Barber PA, Byblow WD. Combining theta burst stimulation with training after subcortical stroke. Stroke. 2010 Jul;41(7):1568-72. doi: 10.1161/STROKEAHA.110.583278. Epub 2010 May 20.

    PubMed 20489170
  • Xiang H, Sun J, Tang X, Zeng K, Wu X. The effect and optimal parameters of repetitive transcranial magnetic stimulation on motor recovery in stroke patients: a systematic review and meta-analysis of randomized controlled trials. Clin Rehabil. 2019 May;33(5):847-864. doi: 10.1177/0269215519829897. Epub 2019 Feb 18.

    PubMed 30773896
  • Zhang L, Xing G, Fan Y, Guo Z, Chen H, Mu Q. Short- and Long-term Effects of Repetitive Transcranial Magnetic Stimulation on Upper Limb Motor Function after Stroke: a Systematic Review and Meta-Analysis. Clin Rehabil. 2017 Sep;31(9):1137-1153. doi: 10.1177/0269215517692386. Epub 2017 Feb 17.

    PubMed 28786336
  • van Lieshout ECC, van der Worp HB, Visser-Meily JMA, Dijkhuizen RM. Timing of Repetitive Transcranial Magnetic Stimulation Onset for Upper Limb Function After Stroke: A Systematic Review and Meta-Analysis. Front Neurol. 2019 Dec 3;10:1269. doi: 10.3389/fneur.2019.01269. eCollection 2019.

    PubMed 31849827
  • Chung SW, Hill AT, Rogasch NC, Hoy KE, Fitzgerald PB. Use of theta-burst stimulation in changing excitability of motor cortex: A systematic review and meta-analysis. Neurosci Biobehav Rev. 2016 Apr;63:43-64. doi: 10.1016/j.neubiorev.2016.01.008. Epub 2016 Feb 3.

    PubMed 26850210
  • Kim JH. Effects of a virtual reality video game exercise program on upper extremity function and daily living activities in stroke patients. J Phys Ther Sci. 2018 Dec;30(12):1408-1411. doi: 10.1589/jpts.30.1408. Epub 2018 Nov 21.

    PubMed 30568325
  • Diekhoff-Krebs S, Pool EM, Sarfeld AS, Rehme AK, Eickhoff SB, Fink GR, Grefkes C. Interindividual differences in motor network connectivity and behavioral response to iTBS in stroke patients. Neuroimage Clin. 2017 Jun 4;15:559-571. doi: 10.1016/j.nicl.2017.06.006. eCollection 2017.

    PubMed 28652969
  • Li CT, Huang YZ, Bai YM, Tsai SJ, Su TP, Cheng CM. Critical role of glutamatergic and GABAergic neurotransmission in the central mechanisms of theta-burst stimulation. Hum Brain Mapp. 2019 Apr 15;40(6):2001-2009. doi: 10.1002/hbm.24485. Epub 2019 Jan 1.

    PubMed 30600571
  • Zhang L, Xing G, Shuai S, Guo Z, Chen H, McClure MA, Chen X, Mu Q. Low-Frequency Repetitive Transcranial Magnetic Stimulation for Stroke-Induced Upper Limb Motor Deficit: A Meta-Analysis. Neural Plast. 2017;2017:2758097. doi: 10.1155/2017/2758097. Epub 2017 Dec 21.

    PubMed 29435371
  • Dionisio A, Duarte IC, Patricio M, Castelo-Branco M. The Use of Repetitive Transcranial Magnetic Stimulation for Stroke Rehabilitation: A Systematic Review. J Stroke Cerebrovasc Dis. 2018 Jan;27(1):1-31. doi: 10.1016/j.jstrokecerebrovasdis.2017.09.008. Epub 2017 Oct 27.

    PubMed 29111342
  • Graef P, Dadalt MLR, Rodrigues DAMDS, Stein C, Pagnussat AS. Transcranial magnetic stimulation combined with upper-limb training for improving function after stroke: A systematic review and meta-analysis. J Neurol Sci. 2016 Oct 15;369:149-158. doi: 10.1016/j.jns.2016.08.016. Epub 2016 Aug 12.

    PubMed 27653882
  • Houdayer E, Degardin A, Cassim F, Bocquillon P, Derambure P, Devanne H. The effects of low- and high-frequency repetitive TMS on the input/output properties of the human corticospinal pathway. Exp Brain Res. 2008 May;187(2):207-17. doi: 10.1007/s00221-008-1294-z. Epub 2008 Feb 8.

    PubMed 18259738
  • Pascual-Leone A, Valls-Sole J, Wassermann EM, Hallett M. Responses to rapid-rate transcranial magnetic stimulation of the human motor cortex. Brain. 1994 Aug;117 ( Pt 4):847-58. doi: 10.1093/brain/117.4.847.

    PubMed 7922470
  • Lin YL, Potter-Baker KA, Cunningham DA, Li M, Sankarasubramanian V, Lee J, Jones S, Sakaie K, Wang X, Machado AG, Plow EB. Stratifying chronic stroke patients based on the influence of contralesional motor cortices: An inter-hemispheric inhibition study. Clin Neurophysiol. 2020 Oct;131(10):2516-2525. doi: 10.1016/j.clinph.2020.06.016. Epub 2020 Jul 3.

    PubMed 32712080

Questions about this trial

What is this clinical trial studying?

A study testing Individualized online stimulation and Non-individualized online stimulation in people with Upper Extremity Dysfunction After the Stroke, run by Ruijin Hospital at 1 site 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 8 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: opening soon, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

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 Yang LIU, Master of Medicine (+8615821650228, ly12446@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fugl-Meyer Assessment - Upper Extremity (FMA-UE) (time frame: Baseline; Day 1 After 2-week intervention; Day 30 after 2-week intervention; Day 90 after 2-week intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07049211, which also lists 26 linked publications.

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 3 Jul 2025; AzTrials last refreshed its copy on 31 Oct 2026.

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