An interventional study of Intermittent Theta Burst Stimulation and Sham Intermittent Theta Burst Stimulation in Stroke, Hemiparesis After Stroke and Chronic Stroke Patients, sponsored by Danderyd Hospital. Recruiting at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-25.
Sponsored by Danderyd Hospital · Not applicable, Interventional, and Treatment
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.
7,283 studies on the registry are indexed under Stroke; 2,013 are open to participants now.
This study's planned enrollment of 56 is above the median of 50 across 5,366 interventional studies indexed under Stroke.
Browse Stroke studies →Danderyd Hospital is the lead sponsor of 58 studies on the registry; 13 are open to participants now.
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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.
Device: Intermittent Theta Burst Stimulation
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.
Device: Sham 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
Also known as: iTBS, TMS
It is identical to its active version, replicates operational sounds, and delivers a very shallow magnetic field to mimic the sensation of magnetic stimulation.
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.
Time frame: At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
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
Captures the participant´s perception of performance in everyday living, over time and is used to set and evaluate goals of an intervention
Time frame: 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)
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, 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.
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 Tensor 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
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).
Time frame: At baseline.
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).
Time frame: 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.
Time frame: After completion of the 5 week intervention to assess acceptability.
Plan to share: No
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