Theta-Burst-Stimulation in early Rehabilitation of Stroke

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 150

Inclusion Criteria

written consent;
age: 40-90 years;
ischemic stroke;
hemiparesis with impaired hand motor function

Exclusion Criteria

Subjects who are legally detained in an official institute (§20 MPG);
Participation in clinical trial within the last 12 weeks;
Electronic implants or ferromagnetic Implants located in the head, neck or thorax (e.g. clips, intracranial shunt, artificial heart valve, pacemaker);
Medication pump (e.g. 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 tumor involving the central nervous system;
Severe Psychiatric disease;
Clinically manifest bilateral hemiparesis or infarcts in the primary motor cortex or along the tractus corticospinalis 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 tractus corticospinalis, excluding microangiopathic changes (e.g. clinically asymptomatic lacunae <1cm);
Known brain lesion (surgical, traumatic);
Evidence for enhanced cerebral pressure;
Severe cardial dysfunction;
life expectancy < 12 months;
NIHSS Score > 20;
Blood glucose imbalances resistant to treatment (<50 mg/dl or >300 mg/dl);
Elevated blood pressure resistant to treatment (RR > 185/110mmHg);
Systemic Thrombolysis using r-tPA or thrombectomy within the last 24 hours before enrollment in study;
Medication with benzodiazepines, high-potency antipsychotics or tricyclic antidepressants before hospitalization or long-term during hospitalization

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
grip force after 3 months (measured with vigorimeter)

Secondary Outcome Measures

Name	Time	Method
After 8 days of intervention, and three months after stroke:<br><br>Grip force (vigorimeter);<br>Motor function (Action Research Arm Test, ARAT; Fugl-Meyer Motor Scale of the upper extremity, FM);<br>Stroke severity (National Instituts of Health Stroke Scale, NIHSS);<br>Degree of disability (modified Rankin Scale, mRS);<br>Motorcortex excitability (Motor evoked potential, MEP; Resting motor threshold, RMT);<br>Quality of life (EuroQol 5D questionnaire, EQ-5D);<br><br>Three months after stroke:<br>Activities of daily living (Barthel-Index, BI) at admission and discharge in external rehabilitation facility;<br>Days of rehabilitation after intervention phase

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