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| Name | Class |
|---|---|
| shanghai center for brain science and brain-inspired technology | UNKNOWN |
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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individualized online stimulation | Experimental | 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. |
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| Non-individualized online stimulation | Active Comparator | 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. |
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| Sham stimulation | Sham Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Individualized online stimulation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline; Day 1 After 2-week intervention; Day 30 after 2-week intervention; Day 90 after 2-week intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yang LIU, Master of Medicine | Contact | +8615821650228 | ly12446@rjh.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Wang, PhD | shanghai center for brain science and brain-inspired technology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Ruijin Hospital, affiliated to Shanghai Jiao Tong University, School of medicine | Shanghai | Shanghai Municipality | 200025 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19678808 | Result | 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. | |
| 20489170 | Result | 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. |
| Label | URL |
|---|---|
| The URL is the data sharing website of this study, which briefly describes the protocol and objectives of the research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| Individual Participant Data Set | View IPD |
We will share the demographic information and baseline clinical data of all participants.
Starting 6 months after publication
Authorized professional researchers, including but not limited to researchers engaged in neuroscience research who have obtained data access permission from their affiliated institutions, and clinical doctors from other medical institutions that have a cooperative relationship with this study and have signed data confidentiality agreements.
They can access the detailed clinical medical histories of the participants, including past disease histories and treatment process records; neurological function assessment scale data; as well as imaging data collected during the study, such as brain magnetic resonance imaging (MRI) results. However, sensitive information related to participants' privacy, such as names, ID numbers, and contact information, will be strictly anonymized to ensure that such information cannot be obtained.
They can contact the corresponding author or the first author via email.
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|
| Non-individualized online stimulation | Device | 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 | Device | 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. |
|
| Baseline; Day 1 After 2-week intervention; Day 30 after 2-week intervention; Day 90 after 2-week intervention |
| 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). | Baseline; Day 1 After 2-week intervention; Day 30 after 2-week intervention; Day 90 after 2-week intervention |
| 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. | Baseline; Day 1 After 2-week intervention; Day 30 after 2-week intervention; Day 90 after 2-week intervention |
| 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. | 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 |
| 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. | Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day7, Day 8, Day 9, Day 10 during TMS intervention |
| 30773896 | Result | 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. |
| 28786336 | Result | 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. |
| 31849827 | Result | 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. |
| 26850210 | Result | 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. |
| 30568325 | Result | 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. |
| 28652969 | Result | 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. |
| 30600571 | Result | 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. |
| 29435371 | Result | 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. |
| 29111342 | Result | 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. |
| 27653882 | Result | 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. |
| 18259738 | Result | 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. |
| 7922470 | Result | 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. |
| 32712080 | Result | 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. |
| 14551397 | Result | Cicinelli P, Pasqualetti P, Zaccagnini M, Traversa R, Oliveri M, Rossini PM. Interhemispheric asymmetries of motor cortex excitability in the postacute stroke stage: a paired-pulse transcranial magnetic stimulation study. Stroke. 2003 Nov;34(11):2653-8. doi: 10.1161/01.STR.0000092122.96722.72. Epub 2003 Oct 9. |
| 14991818 | Result | Murase N, Duque J, Mazzocchio R, Cohen LG. Influence of interhemispheric interactions on motor function in chronic stroke. Ann Neurol. 2004 Mar;55(3):400-9. doi: 10.1002/ana.10848. |
| 19531606 | Result | Nowak DA, Grefkes C, Ameli M, Fink GR. Interhemispheric competition after stroke: brain stimulation to enhance recovery of function of the affected hand. Neurorehabil Neural Repair. 2009 Sep;23(7):641-56. doi: 10.1177/1545968309336661. Epub 2009 Jun 16. |
| 17565358 | Result | Ridding MC, Rothwell JC. Is there a future for therapeutic use of transcranial magnetic stimulation? Nat Rev Neurosci. 2007 Jul;8(7):559-67. doi: 10.1038/nrn2169. |
| 15664172 | Result | Huang YZ, Edwards MJ, Rounis E, Bhatia KP, Rothwell JC. Theta burst stimulation of the human motor cortex. Neuron. 2005 Jan 20;45(2):201-6. doi: 10.1016/j.neuron.2004.12.033. |
| 20636706 | Result | Hachinski V, Donnan GA, Gorelick PB, Hacke W, Cramer SC, Kaste M, Fisher M, Brainin M, Buchan AM, Lo EH, Skolnick BE, Furie KL, Hankey GJ, Kivipelto M, Morris J, Rothwell PM, Sacco RL, Smith SC Jr, Wang Y, Bryer A, Ford GA, Iadecola C, Martins SC, Saver J, Skvortsova V, Bayley M, Bednar MM, Duncan P, Enney L, Finklestein S, Jones TA, Kalra L, Kleim J, Nitkin R, Teasell R, Weiller C, Desai B, Goldberg MP, Heiss WD, Saarelma O, Schwamm LH, Shinohara Y, Trivedi B, Wahlgren N, Wong LK, Hakim A, Norrving B, Prudhomme S, Bornstein NM, Davis SM, Goldstein LB, Leys D, Tuomilehto J. Stroke: working toward a prioritized world agenda. Int J Stroke. 2010 Aug;5(4):238-56. doi: 10.1111/j.1747-4949.2010.00442.x. |
| 30343304 | Result | Dionisio A, Duarte IC, Patricio M, Castelo-Branco M. Transcranial Magnetic Stimulation as an Intervention Tool to Recover from Language, Swallowing and Attentional Deficits after Stroke: A Systematic Review. Cerebrovasc Dis. 2018;46(3-4):178-185. doi: 10.1159/000494213. Epub 2018 Oct 19. |
| 21041783 | Result | Feigin VL, Barker-Collo S, Parag V, Senior H, Lawes CM, Ratnasabapathy Y, Glen E; ASTRO study group. Auckland Stroke Outcomes Study. Part 1: Gender, stroke types, ethnicity, and functional outcomes 5 years poststroke. Neurology. 2010 Nov 2;75(18):1597-607. doi: 10.1212/WNL.0b013e3181fb44b3. |
| 33501848 | Result | Virani SS, Alonso A, Aparicio HJ, Benjamin EJ, Bittencourt MS, Callaway CW, Carson AP, Chamberlain AM, Cheng S, Delling FN, Elkind MSV, Evenson KR, Ferguson JF, Gupta DK, Khan SS, Kissela BM, Knutson KL, Lee CD, Lewis TT, Liu J, Loop MS, Lutsey PL, Ma J, Mackey J, Martin SS, Matchar DB, Mussolino ME, Navaneethan SD, Perak AM, Roth GA, Samad Z, Satou GM, Schroeder EB, Shah SH, Shay CM, Stokes A, VanWagner LB, Wang NY, Tsao CW; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2021 Update: A Report From the American Heart Association. Circulation. 2021 Feb 23;143(8):e254-e743. doi: 10.1161/CIR.0000000000000950. Epub 2021 Jan 27. |
| 19233729 | Result | Feigin VL, Lawes CM, Bennett DA, Barker-Collo SL, Parag V. Worldwide stroke incidence and early case fatality reported in 56 population-based studies: a systematic review. Lancet Neurol. 2009 Apr;8(4):355-69. doi: 10.1016/S1474-4422(09)70025-0. Epub 2009 Feb 21. |
| 1088404 | Result | Hatano S. Experience from a multicentre stroke register: a preliminary report. Bull World Health Organ. 1976;54(5):541-53. |
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. |
| Study Protocol | View IPD | 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. |
| Analytic Code | View IPD | 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. |
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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