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| Name | Class |
|---|---|
| Neurologisches Therapiezentrum Gmundnerberg | OTHER |
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The purpose of this Study is to determine whether non-invasive transcranial direct current stimulation (tDCS) is effective in increasing rehabilitation effects after stroke in visual Cortex.
Visual field defects after posterior cerebral artery stroke can be improved by vision restoration training (VRT), but when combined with transcranial direct current stimulation (tDCS) which alters brain excitability, vision restoration can be potentiated in the chronic stage. Because it is possible that such therapy may be more effective during the early recovery phase after the stroke and can reach patients during the rehabilitation phase, investigators wished to explore the applicability, efficacy and safety of early intervention with a combined tDCS/VRT treatment.
19 post-acute stroke homonymous hemianopia patients were randomly assigned to either 10 sessions of combined rea-tDCS (2mA, 10 daily sessions of 15-20 min) and VRT, or sham-tDCS and VRT. The primary outcome criterion was the pre-post change in perimetric detection thresholds. Secondary outcome is neurophysiological changes in EEG measures (VEP, Connectivity, Spectral Power, ...)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Verum tDCS | Active Comparator | Verum group receiving complete treatment of tDCS |
|
| sham tDCS | Sham Comparator | Sham group receiving sham tDCS |
|
| real VRT | Active Comparator | Real Vision Restoration Training |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| verum tDCS | Device | real transcranial direct current stimulation,10 sessions, 2mA for 20 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of mean sensitivity (in dB) detection threshold from baseline to post-intervention and follow up | 14-20 days post treatment, 3 months follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Change in power spectra (Volts-squared per Hz (V^2/Hz) from baseline to post-intervention and follow up | power spectra (Volts-squared per Hz (V^2/Hz) | 14-20 days post treatment, 3 months follow up |
| Change in VEP latencies (ms) from baseline to post-intervention and follow up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bernhard A Sabel, Prof. Dr. | Institute of Medical Psychology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neurologisches Therapiezentrum Gmundnerberg | Altmünster | 4813 | Austria | |||
| Inst. f. Medical Psychology, Univ. of Magdeburg |
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| ID | Term |
|---|---|
| D006423 | Hemianopsia |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D014786 | Vision Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| sham tDCS | Device | sham transcranial direct current stimulation, 10 sessions, for 20 minutes |
|
| VRT | Behavioral | Vision restoration training, 10 sessions, 20 minutes |
|
VEP latencies (ms) |
| 14-20 days post treatment, 3 months follow up |
| Change in VEP amplitudes (µV) from baseline to post-intervention and follow up | VEP amplitudes (µV) | 14-20 days post treatment, 3 months follow up |
| Change in network coherence from baseline to post-intervention and follow up | network coherence correlations | 14-20 days post treatment, 3 months follow up |
| Number of participants with treatment-related adverse events assessed by a questionnaire | questionnaire recording adverse effects | up to 4 months |
| Magdeburg |
| 39120 |
| Germany |
| D001766 |
| Blindness |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |