Stroke with hemiparesis including impaired hand motor function I63
Conditions
Interventions
Group 1: Repetitive transcranial magnetic stimulation (rTMS) of the primary motor cortex in the lesioned hemisphere using the intermittent theta-burst-stimulation protocol (iTBS
application of 3 pulses with a frequency of 50 Hz, in a theta-rhythm of 5 Hz for 2 seconds, repeated every 10 seconds, duration of one session: about 3,5 minutes) before physiotherapy for 8 days
Group
Sponsors
Universität zu Köln
Eligibility
Sex/Gender
All
Age
40 Years to 90 Years
Inclusion criteria
Inclusion criteria: written consent; age: 40-90 years; ischemic stroke; hemiparesis with impaired hand motor function
Exclusion criteria
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 20; Blood glucose imbalances resistant to treatment (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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| grip force after 3 months (measured with vigorimeter) | — |
Secondary
| Measure | Time frame |
|---|---|
| After 8 days of intervention, and three months after stroke: Grip force (vigorimeter); Motor function (Action Research Arm Test, ARAT; Fugl-Meyer Motor Scale of the upper extremity, FM); Stroke severity (National Instituts of Health Stroke Scale, NIHSS); Degree of disability (modified Rankin Scale, mRS); Motorcortex excitability (Motor evoked potential, MEP; Resting motor threshold, RMT); Quality of life (EuroQol 5D questionnaire, EQ-5D); Three months after stroke: Activities of daily living (Barthel-Index, BI) at admission and discharge in external rehabilitation facility; Days of rehabilitation after intervention phase | — |
Countries
Germany
Contacts
Public ContactLukas Hensel
Klinik und Poliklinik für Neurologie, Universitätsklinikum Köln
Outcome results
None listed