Effects of Intermittent Theta Burst Stimulation (iTBS) on Motor Recovery of Lower Extremity in Chronic Stroke Patients

Официальное название

Neuroplastic Changes and Effects of Intermittent Theta Burst Stimulation (iTBS) on Motor Recovery of Upper and Lower Extremity in Chronic Stroke Patients

Обзор

This study aims to evaluate the effects and clinical feasibility of non-invasive brain stimulation protocols, specifically intermittent Theta Burst Stimulation, as part of rehabilitation interventions for motor recovery of lower extremity in the chronic phase after stroke. It also seeks to explore the underlying mechanisms by investigating changes of functional and structural brain networks.

Подробное описание

In this randomized control trial (RCT) group A will receive iTBS while group B will receive sham iTBS. Both groups will directly after the intervention receive 45 minutes of conventional physical therapy 3 times per week for 5 weeks, a total of 15 interventions by a blinded physiotherapist. For the iTBS intervention a Magstim Rapid² stimulator will be used also equipped with a Cadwell Sierra Summit EMG system \[for motor evoked potential (MEP) measurements\] and an ANT Visor2™ neuronavigation system \[for navigated transcranial magnetic stimulation (TMS) interventions\]. The iTBS parameters that will be used are: 600 pulses under 190 seconds at 80 % of Active Motor Threshold (AMT). The contralesional cerebellum will be targeted. The participants and clinical assessors will be blinded to the intervention.

All the patients will undergo advanced neuroimaging examinations before and after the intervention period. The exams will be then compared to identify neuroplastic changes in brain circuits.

Вмешательства

• Устройство Intermittent Theta Burst Stimulation
  iTBS protocol: 600 pulses at 80% of AMT for 190 sec on the contralesional cerebellum, targeted with the support of a neuronavigational system, 15 sessions over a period of 5 weeks
• Устройство Sham Intermittent Theta Burst Stimulation
  It is identical to its active version, replicates operational sounds, and delivers a very shallow magnetic field to mimic the sensation of magnetic stimulation.

Первичные конечные точки

• miniBest test [Срок оценки: At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.]

Вторичные конечные точки (12)

• Fugl-Meyer Assessment - Lower Extremity [Срок оценки: At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.]
• Modified Ashworth Scale (MAS) [Срок оценки: At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.]
• Neuroflexor [Срок оценки: At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.]
• Lower Extremity Motor Coordination Test (LEMOCOT) [Срок оценки: At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.]
• 6 minutes walk test [Срок оценки: At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.]
• Functional Ambulation Categories (FAC) [Срок оценки: At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.]
• Falls Efficacy Scale Swedish version (FES-S) [Срок оценки: At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.]
• Walking impact scale (MSWS-12 S) [Срок оценки: At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.]
• Canadian Occupational Performance Measure [Срок оценки: At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.]
• Montreal Cognitive Assessment (MoCA) [Срок оценки: At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.]
• Stroke Impact Scale (SIS) [Срок оценки: At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.]
• Motor Evoked Potentials (MEPs) [Срок оценки: At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.]

Критерии участия

Критерии включения

• Age over 18
• Chronic stroke (>6 months)
• Residual hemiparesis FAC ≥3

Критерии исключения

• Metal implants
• Epilepsy/seizures
• Pregnancy
• Claustrophobia (related to MRIs exams)
• Severe cognitive impairment
• Untreated or unstable depression/anxiety
• Other disabilities prohibiting intensive physical training

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

Швеция · 1 центр

• Department of Rehabilitation Medicine, Danderyd Hospital, Danderyd, Stockholm 18288 — Stockholm

Публикации

• Ramnani N. The primate cortico-cerebellar system: anatomy and function. Nat Rev Neurosci. 2006 Jul;7(7):511-22. doi: 10.1038/nrn1953. PMID 16791141
• Wang J, Wu Z, Hong S, Ye H, Zhang Y, Lin Q, Chen Z, Zheng L, Qin J. Cerebellar transcranial magnetic stimulation for improving balance capacity and activity of daily living in stroke patients: a systematic review and meta-analysis. BMC Neurol. 2024 Jun 15;24(1):205. doi: 10.1186/s12883-024-03720-1. PMID 38879485
• Wang C, Zhang Q, Zhang L, Zhao D, Xu Y, Liu Z, Wu C, Wu S, Yong M, Wu L. Comparative efficacy of different repetitive transcranial magnetic stimulation protocols for lower extremity motor function in stroke patients: a network meta-analysis. Front Neurosci. 2024 Feb 15;18:1352212. doi: 10.3389/fnins.2024.1352212. eCollection 2024. PMID 38426021
• Koch G, Bonni S, Casula EP, Iosa M, Paolucci S, Pellicciari MC, Cinnera AM, Ponzo V, Maiella M, Picazio S, Sallustio F, Caltagirone C. Effect of Cerebellar Stimulation on Gait and Balance Recovery in Patients With Hemiparetic Stroke: A Randomized Clinical Trial. JAMA Neurol. 2019 Feb 1;76(2):170-178. doi: 10.1001/jamaneurol.2018.3639. PMID 30476999
• Jiang T, Wei X, Wang M, Xu J, Xia N, Lu M. Theta burst stimulation: what role does it play in stroke rehabilitation? A systematic review of the existing evidence. BMC Neurol. 2024 Feb 1;24(1):52. doi: 10.1186/s12883-023-03492-0. PMID 38297193
• Fan H, Song Y, Cen X, Yu P, Biro I, Gu Y. The Effect of Repetitive Transcranial Magnetic Stimulation on Lower-Limb Motor Ability in Stroke Patients: A Systematic Review. Front Hum Neurosci. 2021 Sep 1;15:620573. doi: 10.3389/fnhum.2021.620573. eCollection 2021. PMID 34539362
• Lefaucheur JP, Andre-Obadia N, Antal A, Ayache SS, Baeken C, Benninger DH, Cantello RM, Cincotta M, de Carvalho M, De Ridder D, Devanne H, Di Lazzaro V, Filipovic SR, Hummel FC, Jaaskelainen SK, Kimiskidis VK, Koch G, Langguth B, Nyffeler T, Oliviero A, Padberg F, Poulet E, Rossi S, Rossini PM, Rothwell JC, Schonfeldt-Lecuona C, Siebner HR, Slotema CW, Stagg CJ, Valls-Sole J, Ziemann U, Paulus W, PMID 25034472
• Christiansen MG, Senko AW, Anikeeva P. Magnetic Strategies for Nervous System Control. Annu Rev Neurosci. 2019 Jul 8;42:271-293. doi: 10.1146/annurev-neuro-070918-050241. Epub 2019 Apr 2. PMID 30939100

Идентификаторы

NCT: NCT07073235 · iTBS-study lower extremity

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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