We will investigate the therapeutic efficacy of EEG-synchronized noninvasive repetitive transcranial magnetic stimulation (rTMS) in the early subacute phase after ischemic stroke to improve upper limb motor rehabilitation. We hypothesize that synchronization of rTMS with the phase of the ongoing sensorimotor oscillation indicating high corticospinal excitability leads to significantly stronger improvement of paretic upper limb motor function than the same rTMS protocol non-synchronized to the ongoing sensorimotor oscillation or sham stimulation.
High-frequency rTMS will be applied to the ipsilesional motor cortex in 400 bursts of 100 Hz triplets with a mean inter-burst interval of 3 s (20 min treatment duration, 1,200 pulses per day) for 5 consecutive workdays (6,000 pulses total) at a stimulus intensity of 80% of resting motor threshold, in one of three conditions/arms, followed by 40 min task-specific hand/arm-physiotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
144
The bossdevice is a real-time digital signal processor consisting of hardware and software algorithms. It is designed to read-in a real-time raw data stream from a bio-signal amplifier (electroencephalography, EEG), to continuously analyze this data and to detect patterns based on oscillations in different frequencies. When such a specific bio-signal pattern is detected, the device indicates this through a standard output port. This enables a connected device to know with millisecond accuracy when a specific biosignal pattern occurs.
Universitätsklinikum Frankfurt, Zentrum der Neurologie und Neurochirurgie
Frankfurt a.M., Frankfurt a.M., Germany
RECRUITINGUniklinik Köln, Klinik und Poliklinik für Neurologie
Cologne, Germany
RECRUITINGUniversitätsklinikum Münster, Klinik für Allgemeine Neurologie
Münster, Germany
RECRUITINGUniversitätsklinikum Tübingen, Klinik für Neurologie
Tübingen, Germany
RECRUITINGMotor performance after the intervention
Primary efficacy endpoint is the motor performance after the intervention, as assessed by the Fugl-Meyer assessment (FMA-UE, range 0-66, 0 = no motor function, 66 = normal motor function) of the upper extremity (FMA-UE). The upper-extremity (UE) portion of the Fugl-Meyer assessment is the most frequently used scale to quantify post-stroke motor recovery of the upper extremity. The FMA-UE was used as an endpoint in most of the recent high-frequency rTMS trials in early subacute stroke patients.
Time frame: After the last treatment session (5 days after first treatment)
Motor performance after 3 months
Motor performance 3 months after the intervention, as assessed by the FMA-UE
Time frame: 3 months after the intervention
grip strength
Relative grip strength measured with a vigorimeter (measured in kg).
Time frame: At screening and after 3 months after treatment
Assessment to measure quality of life
Stroke-Specific Quality-of-Life Scale (SS-QOL)
Time frame: At screening and after 3 months after treatment
modified Rankin Scale Score
Rankin Scale Score (range 0-6, 0 = no disability, 6 =death)
Time frame: At screening and after 3 months after treatment
Barthel Index
Barthel Index (ordinary scale ordinal scale 0-100, 0 = fully dependent, 100 =independent in feeding, walking and grooming)
Time frame: At screening and after 3 months after treatment
inpatient/npatient rehabilitation
* Number of days as an inpatient (in days) * Number of days in inpatient rehabilitation (in days)
Time frame: At screening and after 3 months after treatment
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