Table 2.
: Overview of data collection and study timings
Study period | Pre-enrolment | T0 | T1 | T2 | T3 | T4 | T5 | T6 | T7 | T8 | T9 | T10 |
Visits | ||||||||||||
Screening (in-/exclusion criteria) | X | |||||||||||
Written informed consent | X | |||||||||||
Randomisation | X | |||||||||||
Medical history | X | X | ||||||||||
Neuroimaging (MRI/CT) | X | |||||||||||
TMS-intervention (M1 iTBS/control iTBS) | X | X | X | X | X | X | X | X | ||||
Physiotherapy | X | X | X | X | X | X | X | X | ||||
Assessment of adverse events | X | X | X | X | X | X | X | X | X | X | X | |
Relative grip strength | X | X | X | X | X | X | X | X | X | X | X | X |
Documentation of medication | X | X | X | X | X | X | X | X | X | X | X | |
Neurological examination | X | X | X | X | ||||||||
Electrophysiological examination (RMT, MEPs) | X | X | X | |||||||||
Upper limb motor function (ARAT, FM) | X | X | X | |||||||||
Stroke severity (NIHSS) | X | X | X | |||||||||
Disability (mRS) | X | X | X | |||||||||
Quality of life (EQ-5D) | X | X | X | |||||||||
Assessment of external rehabilitation time | X |
ARAT, Action Research Arm Test; EQ-5D, EuroQol 5D including the visual analogue scale; FM, Fugl-Meyer Motor Scale of the upper extremity;iTBS, intermittent theta burst stimulation; MEPs, Motor evoked potentials; mRS, modified Rankin Scale; NIHSS, National Institutes of Health Stroke Scale;RMT, resting motor threshold.