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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
48
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
It is identical to its active version, replicates operational sounds, and delivers a very shallow magnetic field to mimic the sensation of magnetic stimulation
Department of Rehabilitation Medicine, Danderyd Hospital, Danderyd, Stockholm 18288, Stockholm
Stockholm, Sweden
RECRUITINGFugl-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.
Time frame: At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.
Modified Ashworth Scale (MAS)
Assesses spasticity on a 6 point scale/muscle (0p no impairment, 5p max impairment/muscle)
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.
Dextrain Manipulandum™
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At baseline and after completion of the 5 week intervention to assess changes.
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