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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 upper 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 controlled 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 ipsilesional motor cortex 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 |
|---|---|---|---|
| Ipsilesional motor cortex iTBS and conventional rehabilitation | Experimental | The experimental group will receive intermittent theta burst stimulation on the ipsilesional motor cortex followed by 45 minutes of conventional rehabilitation interventions involving the upper extremity led or instructed by a physiotherapist. |
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| Ipsilesional motor cortex sham-iTBS and conventional rehabilitation | Sham Comparator | The placebo group will receive sham intermittent theta burst stimulation on the ipsilesional motor cortex 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 ipsilesional motor cortex, targeted with the support of a neuronavigational system, 15 sessions over a period of 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Fugl-Meyer Assessment - Upper Extremity | used to quantify recovery of sensorimotor function in the upper extremity after a stroke. It is a 63 item test scored on a 3-level ordinal scale. The score ranges from 0 to 126 points. A higher score indicates recovery of sensorimotor function. | At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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, Stockholm | Recruiting | Stockholm | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18558853 | Background | Lemon RN. Descending pathways in motor control. Annu Rev Neurosci. 2008;31:195-218. doi: 10.1146/annurev.neuro.31.060407.125547. | |
| 35317611 | Background | Zhang JJ, Bai Z, Fong KNK. Priming Intermittent Theta Burst Stimulation for Hemiparetic Upper Limb After Stroke: A Randomized Controlled Trial. Stroke. 2022 Jul;53(7):2171-2181. doi: 10.1161/STROKEAHA.121.037870. Epub 2022 Mar 23. |
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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 |
|
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. |
| Box and Block Test (BBT) | measures unilateral gross manual dexterity. The score is based on the number of blocks transferred from one compartment to the other compartment in 60 seconds. Higher scores indicate better manual dexterity. | At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up. |
| Action Research Arm Test (ARAT) | assesses upper extremity activity capacity in people with stroke. It is a 19-item test scored on a 4-level ordinal scale (0-3). The score ranges from 0 to 57. Higher scores indicate better performance of the upper extremity. | At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up. |
| Dextrain Manipulandumâ„¢ | allows measurement of flexion-extension finger movements. Force sensors are incorporated in the ergonomically designed tool allowing precision measurement of finger movements. The tool is coupled with specific exercises for evaluation of key components of manual dexterity. | At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up. |
| Hand-held Dynamometer/Grip Strength | A quantitative and objective measure of isometric muscular strength of the hand and forearm. This instrument is scored using force production: kilograms or pounds. Maximum grip is the mean of three trials. | At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up. |
| Purdue Pegboard Test (PPT) | is a test of fingertip dexterity and gross movement of the hand, fingers and arm in patients with impairments of the upper extremity resulting from neurological and musculoskeletal conditions. Number of correctly placed pinns within a time frame are counted and a higher scores indicate better dexterity. | At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up. |
| Visuomotor force tracking | Subjects perform a visually guided, isometric precision grip ramp-and-hold force-tracking task by holding a manipulandum. The standardized visuomotor ramp-and-hold task is performed by following the target force with a cursor on a screen as precisely as possible. | At baseline and after completion of the 5 week intervention and at the 12 weeks follow up, to assess changes |
| 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. |
| Canadian Occupational Performance Measure | Capture the participant´s perception of performance in everyday living and will be used to set goals for the intervention. | 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 and after completion of the 5 week intervention and at the 12 weeks follow up, to assess changes |
| 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 Tension 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. |
| 38671584 | Background | Zhang JJ, Sui Y, Sack AT, Bai Z, Kwong PWH, Sanchez Vidana DI, Xiong L, Fong KNK. Theta burst stimulation for enhancing upper extremity motor functions after stroke: a systematic review of clinical and mechanistic evidence. Rev Neurosci. 2024 Apr 29;35(6):679-695. doi: 10.1515/revneuro-2024-0030. Print 2024 Aug 27. |
| 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. |
| 31849827 | Background | 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. |
| 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. |
| 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. |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D006429 | Hemiplegia |
| 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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