The present study aims at investigating the effects of intermittent theta-burst stimulation (iTBS) for motor recovery in recurrent stroke patients. Therefore a daily intervention of repetitive transcranial magnetic stimulation over 8 days combined with subsequent physiotherapy is compared to a control condition, sham stimulation combined with subsequent physiotherapy. Motor function, degree of disability and quality of life are examined in order to evaluate the effects of iTBS in the rehabilitation of recurrent stroke patients in the first weeks and after three months.
To date, the majority of neuromodulation approaches aiming at improving motor recovery after stroke are limited to patients with first-ever ischemic stroke. Therefore, rehabilitation of recurrent stroke mainly includes physiotherapy and occupational therapy. Yet, particular these patients retain movement impairment relevant for activities of daily living. By using repetitive transcranial magnetic stimulation (rTMS), it is possible to promote recovery of connectivity between brain regions, particularly after stroke and thereby improve motor performance. Previous data indicate that intermittent theta-burst stimulation (iTBS), a protocol of neuromodulation, enhances the effects of subsequent motor training in early rehabilitation after stroke. The current study aims at investigating whether daily repetitive transcranial magnetic stimulation over 8 days combined with subsequent physiotherapy leads to better motor recovery in recurrent stroke, compared to control condition, physiotherapy after sham stimulation. Motor function, degree of disability and quality of life are examined in order to evaluate the effects of iTBS in the rehabilitation of recurrent stroke patients in the first weeks and after three months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
60
Intermittent theta-burst-stimulation (iTBS) protocol
Sham stimulation
Christian Grefkles
Cologne, Germany
Relative grip force
grip force as measured with vigorimeter
Time frame: 3 months after enrollment
Relative grip force
Grip force as measured with vigorimeter
Time frame: After 8 days of intervention, and 3 months of enrollment
Motor function
Action Research Arm Test, ARAT
Time frame: After 8 days of intervention, and 3 months of enrollment
Motor function
Fugl-Meyer Motor Scale of the upper extremity, FM The Fugl-Meyer Assessment scale is an ordinal scale that has 3 points for each item. A zero score is given for the item if the subject cannot do the task. A score of 1 is given when the task is performed partially and a score of 2 is given when the task is performed fully. Minimum score in upper limb = 0 Maximum score in upper limb = 66, Subscales are summed
Time frame: After 8 days of intervention, and 3 months of enrollment
Stroke severity
National Instituts of Health Stroke Scale, NIHSS The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.
Time frame: After 8 days of intervention, and 3 months of enrollment
Degree of disability
Modified Rankin Scale, mRS The scale runs from 0-6, running from perfect health (0) without symptoms to death (6).
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Time frame: After 8 days of intervention, and 3 months of enrollment
Motor cortex excitability/ Motor evoked potential
Motor evoked potential (MEP) induced by stimulation of the affected motor cortex
Time frame: After 8 days of intervention, and 3 months of enrollment
Motor cortex excitability/ Resting motor threshold
Resting motor threshold as measured by stimulation of the affected motor cortex, RMT
Time frame: After 8 days of intervention, and 3 months of enrollment
Motor cortex excitability/ Short-interval intracortical inhibition
Short-interval intracortical inhibition Short-interval intracortical inhibition (SICI) is a widely used paired-pulse transcranial magnetic stimulation (TMS) measure to assess inhibition in human motor cortex
Time frame: After 8 days of intervention, and 3 months of enrollment
Motor cortex excitability/ Ipsilateral silent period
Ipsilateral silent period The ipsilateral silent period (iSP) is supposed to be a specific marker of transcallosal motor inhibition. Measured by a short attenuation or interruption of ongoing voluntary electromyographic (EMG) activity in hand muscles induced by focal TMS of the ipsilateral M1.
Time frame: After 8 days of intervention, and 3 months of enrollment
Quality of life
EuroQol 5D questionnaire, EQ-5D
Time frame: After 8 days of intervention, and 3 months of enrollment
Activities of daily living at admission and discharge in external rehabilitation facility
Barthel-Index (BI) scores as documented by external rehabilitation facility The Barthel scale is an ordinal scale used to measure performance in activities of daily living (ADL). A higher number is associated with a greater likelihood of being able to live at home with a degree of independence following discharge from hospital. The scale yield a score of 0-100.
Time frame: After 8 days of intervention, and 3 months of enrollment
Days of rehabilitation after intervention phase
Days of rehabilitation after intervention phase as documented by external rehabilitation facility
Time frame: 3 months after enrollment