Department of Rehabilitation Medicine, Danderyd Hospital, Danderyd, Stockholm 18288
Stockholm, Sweden
Location status: Recruiting
NCT Number: NCT07073235
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Stockholm, Sweden
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Other names: 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.
Time frame: At baseline, after completion of the 5 week intervention to assess change as well at 12 weeks follow up.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 and after completion of the 5 week intervention to assess changes.
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
a method aimed at mapping structural correlations between brain regions.
Time frame: At baseline.
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.
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: After completion of the 5 week intervention to assess acceptability.
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.
Contact information is provided by the study sponsor or research team.
Danderyd Hospital
Other
Neuroplastic Changes and Effects of Intermittent Theta Burst Stimulation (iTBS) on Motor Recovery of Upper and Lower Extremity in Chronic Stroke Patients
Acronym: NIMBLE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07073248
Brain Diseases, Cardiovascular Diseases
Stockholm, Sweden
View Trial DetailsNCT03870672
Brain Diseases, Cardiovascular Diseases
Cleveland, Ohio, United States
View Trial DetailsNCT07053917
Brain Diseases, Brain Infarction
Baltimore, Maryland, United States
View Trial DetailsNCT05866003
Brain Diseases, Cardiovascular Diseases
Cleveland, Ohio, United States
View Trial Details