Individualized rTMS Synchronized Task Training for Closed-loop Neuromodulation of Post-stroke Motor Dysfunction
NCT ID: NCT07049211
Last Updated: 2025-07-03
Study Results
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Basic Information
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NOT_YET_RECRUITING
NA
51 participants
INTERVENTIONAL
2025-07-20
2028-05-20
Brief Summary
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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 ?
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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Individualized online stimulation
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 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.
Individualized online stimulation
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 stimulation
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.
Non-individualized online stimulation
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 stimulation
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.
Sham stimulation
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.
Interventions
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Individualized online stimulation
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 stimulation
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 stimulation
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.
Eligibility Criteria
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Inclusion Criteria
2. The vital signs are stable and there is a certain degree of upper limb motor dysfunction.
3. Motor evoked potentials(MEPs) of First Dorsal Interosseous Muscle（FDI）or Abductor Pollicis Brevis Muscle (APB) is negative in ipsilesional hemisphere.
4. The age is between 20 and 80 years old.
5. The cognitive ability is not significantly affected and the patient can cooperate with various examinations and assessments, with a MMSE score ≥ 20 points.
6. There are no serious complications (such as pneumonia, heart failure, urinary tract infection or malnutrition).
7. 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).
8. The patient or guardian agrees to sign the informed consent form.
Exclusion Criteria
2. Those with a history of aphasia, severe cognitive impairment or mental illness;
3. Patients who have had a history of epileptic seizures in the last month or are taking anti-epileptic drugs recently;
4. Those with severe visual or hearing impairments, unable to communicate normally;
5. People with metal implants, pacemakers, skull defects or other conditions that prevent them from undergoing TMS.
20 Years
80 Years
ALL
No
Sponsors
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shanghai center for brain science and brain-inspired technology
UNKNOWN
Ruijin Hospital
OTHER
Responsible Party
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Qing Xie, PhD
Professor
Principal Investigators
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Wang, PhD
Role: STUDY_DIRECTOR
shanghai center for brain science and brain-inspired technology
Locations
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Shanghai Ruijin Hospital, affiliated to Shanghai Jiao Tong University, School of medicine
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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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.
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.
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.
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Study Documents
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Document Type: Individual Participant Data Set
Method of obtaining the raw data: If there are reasonable requests, the related raw data to support the research results can be obtained from the corresponding authors or the first authors. Data sharing website: https://zenodo.org/records/15080604 Time of making the raw data public: the research raw data will be publicly shared six months after the publication of the research paper.
View DocumentDocument Type: Study Protocol
Method of obtaining the raw data: If there are reasonable requests, the related raw data to support the research results can be obtained from the corresponding authors or the first authors. Data sharing website: https://zenodo.org/records/15080604 Time of making the raw data public: the research raw data will be publicly shared six months after the publication of the research paper.
View DocumentDocument Type: Analytic Code
Method of obtaining the raw data: If there are reasonable requests, the related raw data to support the research results can be obtained from the corresponding authors or the first authors. Data sharing website: https://zenodo.org/records/15080604 Time of making the raw data public: the research raw data will be publicly shared six months after the publication of the research paper.
View DocumentRelated Links
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The URL is the data sharing website of this study, which briefly describes the protocol and objectives of the research.
Other Identifiers
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2025296
Identifier Type: -
Identifier Source: org_study_id
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