Effects of Individualized iTBS on Upper Limb Function After Stroke

Обзор

The primary objective of this clinical study is to assess the comparative efficacy of individualized intermittent theta burst stimulation (iTBS) in contrast to standard iTBS for individuals post-stroke experiencing upper limb impairment. The key inquiries addressed in this study encompass: Enhancement of Upper Limb Function: The primary investigation seeks to determine whether individualized iTBS yields superior improvements in upper limb functionality compared to standard iTBS. Long-Term Effects: This study endeavors to explore the sustained effects of both individualized and standard iTBS on upper limb function over an extended duration. Neural Mechanisms Investigation: Functional near-infrared spectroscopy (fNIRS) will be employed to elucidate the neural mechanisms underlying the impact of iTBS on the enhancement of upper limb function. Post-stroke individuals with upper limb impairment will undergo pre-treatment assessments, including motor function evaluations and fNIRS tests. Subsequently, they will be randomized into three groups: individualized iTBS, standard iTBS, and sham stimulation. Participants will undergo post-treatment assessments and follow-up evaluations. The research team aims to discern disparities in the efficacy of different iTBS modalities. The central hypothesis posits that individualized iTBS will demonstrate superior efficacy in enhancing post-stroke upper limb function, with sustained effects persisting for a minimum of one month.

Подробное описание

This research constitutes a single-center, double-blind, randomized controlled study. Upon enrollment, baseline information is established through the assessment of upper limb function using the Fugl Meyer Assessment (FMA), the modified Rankin Scale, the Action Research Arm Test (ARAT), and a handgrip test. Additionally, functional near-infrared spectroscopy (fNIRS) is employed to assess brain function, providing insights into the patient's motor network.

Participants in the study are randomly assigned to one of three groups: individualized iTBS, standard iTBS, and sham stimulation. All participants undergo physical therapy and occupational therapy tailored to their functional evaluation. After three weeks of treatment, participants are required to complete the aforementioned assessments, with a follow-up evaluation scheduled one month post-treatment.

Вмешательства

• Устройство individualized intermittent theta burst sitmulation (iTBS)
  Participants undergo daily sessions of individualized intermittent theta-burst stimulation (iTBS) administered with the MagStim stimulator (Rapid2, MagStim, Whiteland, United States). The intervention spans five days a week and extends over a three-week period. In this group, participants receive a personalized iTBS protocol comprising three pulses of stimulation delivered at 50 Hz, repeated every 200 ms. The stimulation frequency is tailored based on the electroencephalogram (EEG) results and i
• Устройство standard iTBS
  The MagStim stimulator (Rapid2, MagStim, Whiteland, United States) was employed in the current study. The intermittent theta-burst stimulation (iTBS) protocol utilized three pulses of stimulation delivered at a frequency of 50 Hz, with a repetition rate of every 200 ms. These pulses were organized into 2-second trains, repeated every 10 seconds, resulting in a cumulative duration of 190 seconds (equivalent to a total of 600 pulses). Notably, the administration of the treatment ceased promptly in
• Устройство sham stimulation
  The device and protocol are identical to the standard iTBS, with the only difference being the orientation of the coil, which is perpendicular to the scalp.

Первичные конечные точки

• Fugl-Meyer Assessment-upper extremity [Срок оценки: Befor and after the treatment, and 1 month after the treatment.]

Вторичные конечные точки (4)

• modified Rankin Scale [Срок оценки: Befor and after the treatment, and 1 month after the treatment.]
• Action Research Arm Test [Срок оценки: Befor and after the treatment, and 1 month after the treatment.]
• handrip test [Срок оценки: Befor and after the treatment, and 1 month after the treatment.]
• functional nearinfrared spectroscopy [Срок оценки: Befor and after the treatment, and 1 month after the treatment.]

Критерии участия

Критерии включения

• aging from 18-80
• diagnosed as first-happened stroke,duration of the disease ranged from 1-3 months
• upper extremity impairment
• with mini-mental state examination>15
• agree to participate in this study and sigh the informed consent

Критерии исключения

• with stroke history
• have metal device within the body
• with history of upper extremity trauma,fracture, and/or burn
• serious conditions and can not finish the examination and treatment

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Qilu hospital of Shandong University — Цзинань

Публикации

• Kong G, Wei L, Wang J, Zhu C, Tang Y. The therapeutic potential of personalized connectivity-guided transcranial magnetic stimulation target over group-average target for depression. Brain Stimul. 2022 Sep-Oct;15(5):1063-1064. doi: 10.1016/j.brs.2022.07.054. Epub 2022 Aug 2. No abstract available. PMID 35931377
• Klooster DCW, Ferguson MA, Boon PAJM, Baeken C. Personalizing Repetitive Transcranial Magnetic Stimulation Parameters for Depression Treatment Using Multimodal Neuroimaging. Biol Psychiatry Cogn Neurosci Neuroimaging. 2022 Jun;7(6):536-545. doi: 10.1016/j.bpsc.2021.11.004. Epub 2021 Nov 17. PMID 34800726
• Ferrarelli F, Phillips ML. Examining and Modulating Neural Circuits in Psychiatric Disorders With Transcranial Magnetic Stimulation and Electroencephalography: Present Practices and Future Developments. Am J Psychiatry. 2021 May 1;178(5):400-413. doi: 10.1176/appi.ajp.2020.20071050. Epub 2021 Mar 3. PMID 33653120
• Siddiqi SH, Trapp NT, Shahim P, Hacker CD, Laumann TO, Kandala S, Carter AR, Brody DL. Individualized Connectome-Targeted Transcranial Magnetic Stimulation for Neuropsychiatric Sequelae of Repetitive Traumatic Brain Injury in a Retired NFL Player. J Neuropsychiatry Clin Neurosci. 2019 Summer;31(3):254-263. doi: 10.1176/appi.neuropsych.18100230. Epub 2019 Apr 3. PMID 30945588
• Cassidy JM, Wodeyar A, Wu J, Kaur K, Masuda AK, Srinivasan R, Cramer SC. Low-Frequency Oscillations Are a Biomarker of Injury and Recovery After Stroke. Stroke. 2020 May;51(5):1442-1450. doi: 10.1161/STROKEAHA.120.028932. Epub 2020 Apr 17. PMID 32299324
• Cash RFH, Cocchi L, Anderson R, Rogachov A, Kucyi A, Barnett AJ, Zalesky A, Fitzgerald PB. A multivariate neuroimaging biomarker of individual outcome to transcranial magnetic stimulation in depression. Hum Brain Mapp. 2019 Nov 1;40(16):4618-4629. doi: 10.1002/hbm.24725. Epub 2019 Jul 22. PMID 31332903
• Ge R, Humaira A, Gregory E, Alamian G, MacMillan EL, Barlow L, Todd R, Nestor S, Frangou S, Vila-Rodriguez F. Predictive Value of Acute Neuroplastic Response to rTMS in Treatment Outcome in Depression: A Concurrent TMS-fMRI Trial. Am J Psychiatry. 2022 Jul;179(7):500-508. doi: 10.1176/appi.ajp.21050541. Epub 2022 May 18. PMID 35582784

Идентификаторы

NCT: NCT06147167 · KYLL-202307-023

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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