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Transcranial galvanic stimulation (tDCS) seems to promote motor recovery after stroke by stimulating (anodal) or inhibiting (cathodal) neural circuits in the brain. In the treatment of severe arm paresis after stroke, robot-assisted arm training (AT) proved to be effective, but nevertheless only a few patients could use their affected hand functionally in daily life after robot training. Therefore the present study intends to combine both approaches, tDCS + AT, applied at the same time every day for six weeks. The study has three treatment arms, two groups will receive the tDCS, either anodal of the lesioned or cathodal of the non-lesioned hemisphere. The anodal stimulation is expected to facilitate the activity of the arm motor area of the lesioned side directly, while the cathodal stimulation of the non-lesioned hemisphere is expected to facilitate the lesioned side indirectly by decreasing inhibitory inputs. The third group will receive a sham-stimulation. All patients will work with the AT simultaneously to the tDCS, respectively sham-tDCS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | patients receive 20 min of anodal transcranial stimulation plus 20 min of repetitive arm training with a therapy robot(Bi-Manu-Track) |
|
| 2 | Experimental | patients receive 20 min of cathodal transcranial stimulation plus 20 min of repetitive arm training with a therapy robot(Bi-Manu-Track) |
|
| 3 | Sham Comparator | patients receive 20 min of sham transcranial stimulation plus 20 min of repetitive arm training with a therapy robot(Bi-Manu-Track) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcranial galvanic stimulation | Device | for tDCS: Siemens Universal-Neuroton 826 for arm training: Bi-Manu-Track, Reha-Stim, Berlin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fugl-Meyer Upper Limb Motor Score (0-66) | 45 min |
| Measure | Description | Time Frame |
|---|---|---|
| Box&Block Test | 5 min |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stefan Hesse, MD | Charité -University Medicine Berlin; Medical Park Berlin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité, University Medicine Berlin, Medical Park Berlin | Berlin | 13507 | Germany | |||
| Klinik Bavaria |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D010291 | Paresis |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Kreischa |
| 09567 |
| Germany |
| Villa Melitta | Bolzano | 3600 | Italy |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |