Table 1.

1Trial characteristics based on WHO trial registration dataset

Data category	Trial information
Primary registry and trial identifying number	German Clinical Trials Register (DRKS) DRKS-ID: DRKS00008963
Date of registration in primary registry	16 February 2016
Secondary identifying numbers	ClinicalTrials.gov (NCT02910024)
Source(s) of monetary or material support	The study is conducted as an investigator-initiated study supported by the Max-Delbrück Prize to GRF and by the University of Cologne Emerging Groups Initiative (CONNECT group; CG and GRF) implemented in the Institutional Strategy of the University of Cologne and the German Excellence Initiative.
Primary sponsor	University of Cologne, Albertus-Magnus-Platz 50 923 Cologne
Secondary sponsor	NA
Contact for public queries	Prof Gereon R. Fink (gereon.fink@uk-koeln.de)
Contact for scientific queries	Prof Gereon R. Fink (gereon.fink@uk-koeln.de)
Public title	Theta-Burst-Stimulation in early Rehabilitation of Stroke (TheSiReS)
Scientific title	Theta-Burst-Stimulation in early Rehabilitation of Stroke (TheSiReS)
Country of recruitment	Germany
Healthy conditions(s) or problems studied	Stroke with hemiparesis, including impaired hand–motor function
Interventions	Active comparator: repetitive transcranial magnetic stimulation (rTMS) applied to the primary motor cortex of the lesioned hemisphere using the intermittent theta burst stimulation protocol (application of 3 pulses with a frequency of 50 Hz, in a theta-rhythm of 5 Hz for 2 s, repeated every 10 s, duration of one session: about 3.5 min) before physical therapy for 8 days. Sham comparator: repetitive transcranial magnetic stimulation (rTMS) in control position (tilted coil over parieto-occipital vertex) before physical therapy for 8 days.
Key inclusion and exclusion criteria	Inclusion criteria: written consent, age: 40–90 years, ischaemic stroke. hemiparesis with impaired hand–motor function. Exclusion criteria: Subjects who are legally detained in an official institute (§20 MPG), participation in a clinical trial within the last 12 weeks, electronic implants or ferromagnetic implants located in the head, neck or thorax (eg, clips, intracranial shunt, artificial heart valve, pacemaker), medication pump (eg, insulin pump), metal splinters in eye or head, pregnancy/breastfeeding, severe neurodegenerative disease, severe neuroinflammatory disease, history of seizures/epilepsy, physical addiction to alcohol, medication or drugs (excluded: nicotine), insufficient compliance, present or past malignant tumour involving the central nervous system, severe psychiatric disease, clinically manifest bilateral hemiparesis or infarcts in the primary motor cortex or along the corticospinal tract in the hemisphere ipsilateral to the hemiparesis, pre-existing cerebral infarctions with hemiparesis or pre-existing cerebral infarctions in the primary motor cortex or along the corticospinal tract, excluding microvascular changes (eg, clinically asymptomatic lacunae <1 cm), known brain lesion (surgical, traumatic), evidence for enhanced cerebral pressure, severe cardiac dysfunction, life expectancy <12 months, National Institutes of Health Stroke Scale Score (NIHSS) >20, blood glucose imbalances resistant to treatment (<50 mg/dL or >300 mg/dL), elevated blood pressure resistant to treatment (>185/110 mm Hg), systemic thrombolysis using alteplase or thrombectomy within the last 24 hours before enrolment in study, medication with benzodiazepines, high-potency antipsychotics or tricyclic antidepressants before hospitalisation or long-term during hospitalisation.
Study type	Interventional Allocation: randomised intervention model Masking: double-blind (subject, caregiver, investigator, outcomes assessor). Assignment: parallel Primary purpose:treatment
Date of first enrolment	April 2016
Target sample size	150
Recruitment status	Recruiting
Primary outcome(s)	Relative grip force (time frame: 3–6 months after enrolment)
Key secondary outcome	Relative grip force (time frame: after 8 days of intervention, and 3–6 months after enrolment). Action Research Arm Test (time frame: after 8 days of intervention, and 3–6 months after enrolment), Fugl-Meyer Motor Scale of the upper extremity (time frame: after 8 days of intervention, and 3–6 months after enrolment). NIHSS (time frame: after 8 days of intervention, and 3–6 months after enrolment). modified Rankin Scale (time frame: after 8 days of intervention, and 3–6 months after enrolment). Motor evoked potential induced by stimulation of the affected motor cortex as a measure of motorcortex excitability (time frame: after 8 days of intervention, and 3 –6 months after enrolment). Resting motor threshold as measured by stimulation of the affected motor cortex as a measure of motorcortex excitability (time frame: after 8 days of intervention, and 3–6 months after enrolment). EuroQol 5D questionnaire (time frame: after 8 days of intervention, and 3–6 months after enrolment). Barthel-Index at admission and discharge in external rehabilitation facility (time frame: 3–6 months after enrolment). Days of rehabilitation after intervention phase (time frame: 3–6 months after enrolment).