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| Name | Class |
|---|---|
| Karolinska Institutet | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Contralesional cerebellum iTBS and conventional rehabilitation | Experimental | The experimental group will receive intermittent theta burst stimulation on the contralesional cerebellum followed by 45 minutes of conventional rehabilitation interventions involving the lower extremity led or instructed by a physiotherapist. |
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| Contralesional cerebellum sham-iTBS and conventional rehabilitation | Sham Comparator | The placebo group will get sham intermittent theta burst stimulation on the contralesional cerebellum followed by 45 minutes of conventional rehabilitation interventions involving the lower extremity led or instructed by a physiotherapist. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intermittent Theta Burst Stimulation | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| miniBest test | measures dynamic balance, functional mobility, and gait. It is a 14-item test scored on a 3-level ordinal scale. The score ranges from 0 to 28 points. A higher score indicates better balance. | At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up. |
| Measure | Description | Time Frame |
|---|---|---|
| Fugl-Meyer Assessment - Lower Extremity | used to quantify sensorimotor function recovery after a stroke. It is a 43 item test scored on a 3-level ordinal scale. The score ranges from 0 to 86 points. A higher score indicates higher sensorimotor recovery. | At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up. |
| Measure | Description | Time Frame |
|---|---|---|
| National Institutes of Health Stroke Scale (NIHSS) | quantifies stroke severity based on weighted evaluation findings. The total NIHSS score ranges from 0 to 42, with higher scores indicating more severe strokes, categorized as follows: minor stroke (1-4), moderate stroke (5-15), moderate to severe stroke (16-20), and severe stroke (21-42). | At baseline. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Susanne Palmcrantz, PhD, Associate Professor | Contact | 004681235000 | susanne.palmcrantz@ki.se |
| Name | Affiliation | Role |
|---|---|---|
| Susanne Palmcrantz, PhD, Associate Professor | Dep of Clinical Sciences, Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Rehabilitation Medicine, Danderyd Hospital, Danderyd, Stockholm 18288 | Recruiting | Stockholm | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16791141 | Background | Ramnani N. The primate cortico-cerebellar system: anatomy and function. Nat Rev Neurosci. 2006 Jul;7(7):511-22. doi: 10.1038/nrn1953. | |
| 38879485 | Background | 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. |
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Randomized controlled trial
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| Sham Intermittent Theta Burst Stimulation | Device | It is identical to its active version, replicates operational sounds, and delivers a very shallow magnetic field to mimic the sensation of magnetic stimulation. |
|
| Modified Ashworth Scale (MAS) | Assesses spasticity on a 6 point scale/muscle (0p no impairment, 5p max impairment/muscle). | At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up. |
| Neuroflexor | Medical technology device. Assesses spasticity by identifying the neural, viscous and elastic components during passive movement using a biomechanical algorithm (presented in Newton) | 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) | assesses motor coordination deficits after stroke. The LEMOCOT assesses how many times a participant can alternately touch a proximal and distal target with their big toe within 20 seconds. Higher scores indicate better motor coordination in the lower extremity. | At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up. |
| 6 minutes walk test | assess submaximal aerobic/functional walking capacity, community walking prediction. Assesses walking endurance in meters walked. Longer distances indicate better walking capacity. | At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up. |
| Functional Ambulation Categories (FAC) | evaluates ambulation ability. It ranges from 0 to 5. Higher score indicates more independent ambulation. | 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) | measure the level of concern about falling during social and physical activities inside and outside home. The total score ranges from 0 to 130. A higher total score on the FES-S indicates greater confidence in performing the activities without falling. | 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) | Assesses self-perceived limitations in walking. The score ranges from 12 to 60 (12p no impairments, 60p max impairment). | At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up. |
| Canadian Occupational Performance Measure | Captures the participant´s perception of performance in everyday living, over time and is used to set and evaluate goals of an intervention | At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up. |
| Montreal Cognitive Assessment (MoCA) | Assesses mental function (0p max impairment summed up to 30p no detected impairment) | At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up. |
| Stroke Impact Scale (SIS) | is a self-report questionnaire that evaluates disability and health-related quality of life after stroke. It has 8 domains: strength, hand function, mobility, physical and instrumental activities of daily living (ADL and IADL), memory and thinking, communication, emotion, and social participation. It uses a 5-point Likert scale to assess the difficulty of performing various tasks within each domain. Higher scores indicate better outcome | At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up. |
| Motor Evoked Potentials (MEPs) | electrical signals recorded from neural tissue or muscle following activation of central motor pathways. MEPs assess the integrity of descending motor pathways. | At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up. |
| Resting state functional MRI (rs-fMRI) | a method aimed at examining intrinsic networks in the brain while no task is performed (rest); this is to estimate correlations between brain regions. | At baseline and after completion of the 5 week intervention to assess changes. |
| Diffusion Tensor Imaging (DTI) | a method aimed at mapping structural correlations between brain regions. | At baseline and after completion of the 5 week intervention to assess changes |
| Barthel Index (BI) | measures a person's ability to complete activities of daily living (ADL). Scores range from 0 to 100, categorized as follows: Total dependence (0-20), Severe dependence (21-60), Moderate dependence (61-90), Slight dependence (91-99), and Independence (100). | At baseline. |
| Theoretical Framework of Acceptability questionnaire | to assess the acceptability of healthcare interventions, based on the developed Theoretical Framework of Acceptability (TFA). It uses a 5-point Likert scale to assess acceptability of the intervention. Higher scores indicate higher acceptability. | After completion of the 5 week intervention to assess acceptability. |
| 38426021 | Background | 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. |
| 30476999 | Background | 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. |
| 38297193 | Background | 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. |
| 34539362 | Background | 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. |
| 25034472 | Background | 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, Garcia-Larrea L. Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS). Clin Neurophysiol. 2014 Nov;125(11):2150-2206. doi: 10.1016/j.clinph.2014.05.021. Epub 2014 Jun 5. |
| 30939100 | Background | 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. |
| 36437474 | Background | Qi S, Tian M, Rao Y, Sun C, Li X, Qiao J, Huang ZG. Applying transcranial magnetic stimulation to rehabilitation of poststroke lower extremity function and an improvement: Individual-target TMS. Wiley Interdiscip Rev Cogn Sci. 2023 Mar;14(2):e1636. doi: 10.1002/wcs.1636. Epub 2022 Nov 27. |
| 36426136 | Background | Fan J, Fu H, Xie X, Zhong D, Li Y, Liu X, Zhang H, Zhang J, Huang J, Li J, Jin R, Zheng Z. The effectiveness and safety of repetitive transcranial magnetic stimulation on spasticity after upper motor neuron injury: A systematic review and meta-analysis. Front Neural Circuits. 2022 Nov 8;16:973561. doi: 10.3389/fncir.2022.973561. eCollection 2022. |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D006429 | Hemiplegia |
| D051346 | Mobility Limitation |
| D010291 | Paresis |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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