Theta-Burst-Stimulation in Recurrent Stroke Recovery

Phase 2

Recruiting

Conditions: I63.0
Cerebral infarction due to thrombosis of precerebral arteries

Registration Number: DRKS00013283

Lead Sponsor: Klinik und Poliklinik für NeurologieUniversitätsklinikum Köln

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

Subjects who are legally detained in an official institute (§20 MPG)
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
Frequent 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
Relative grip force 3 months after enrollment (as measured with vigorimeter)

Secondary Outcome Measures

Name	Time	Method
After 8 days of intervention, and 3 months of enrollment:<br>Relative 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>Motor cortex excitability (Motor evoked potential<br>Motor evoked potential, MEP; Resting motor threshold of the affected motor cortex, RMT; Short-interval intracortical inhibition, SICI; Ipsilateral silent period, iSP)<br>Quality of life (EuroQol 5D questionnaire, EQ-5D)<br><br>Activities of daily living at admission and discharge in external rehabilitation facility (Barthel-Index, BI)<br>Days of rehabilitation after intervention phase