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.
Age ≥ 18 years at the time of signing the informed consent.
Cerebral ischemia identified by brain imaging (cerebral MRI or CT) occurred 1-14 days ago.
Subject understands and voluntarily signs an informed consent document prior to any study related assessments/procedures.
Stroke has resulted in a new arm-/hand motor deficit with ≤ 50 points in the FMA-UE.
Hemorrhagic stroke (this refers to primary intracerebral hemorrhage only; hemorrhagic transformation of ischemic infarcts is not an exclusion criterion)
Estimated life expectancy < 12 months
Presence of intracranial ferromagnetic metal (extracranial stents ≥10 cm away from the TMS coil are acceptable) in accordance with current safety guidelines [18]
Intraocular metal, cochlear implants
Parallel
Bossdevice
DeviceThe 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.
Motor 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.
Motor performance after 3 months
Motor performance 3 months after the intervention, as assessed by the FMA-UE
grip strength
Relative grip strength measured with a vigorimeter (measured in kg).
Assessment to measure quality of life
Stroke-Specific Quality-of-Life Scale (SS-QOL)
modified Rankin Scale Score
Rankin Scale Score (range 0-6, 0 = no disability, 6 =death)
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