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| Name | Class |
|---|---|
| EBS Technologies GmbH | INDUSTRY |
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Non-invasive brain stimulation can increase cortical excitability in the visual system, but it is not known if this is of clinical value. The investigators now assessed if repetitive, transcranial alternating current stimulation (rtACS) can improve visual field size in patients with optic nerve damage. The investigators hypothesized that rtACS would improve visual functions with the defective visual field sectors of the visual field (primary outcome measure).
exploratory, randomized, controlled study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rtACS (Verum condition) | Experimental | Repetitive transorbital alternating current stimulation (rtACS) |
|
| Placebo stimulation | Placebo Comparator | no intervention (Sham stimulation) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rtACS (verum condition) | Device | Repetitive, transorbital alternating current stimulation (rtACS) was applied with a multi-channel device generating weak current pulses in predetermined firing bursts of 2 to 9 pulses. The amplitude of each current pulse was below 1000 microA. Current intensity was individually adjusted according to how well patients perceived phosphenes, i.e. any sensation of flickering light in response to the rtACS stimulation. |
| Measure | Description | Time Frame |
|---|---|---|
| Detection accuracy (DA) change in percent over baseline within defective visual field sectors | Central visus fields were assessed with computer based high-resolution perimetry (HRP). Based on such plots, areas of the visual field were characterized as intact, partially damaged or absolutely impaired (blind). | between baseline and 60 days after stimulation |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Parameters 1 | DA in static and kinetic perimetry | baseline to 60 days after stimulation |
| Visual Parameters 2 | reaction time (RT) in HRP |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bernhard A Sabel, Prof. Dr. | University of Magdeburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinik für Neurologie, Charité Campus Mitte, Universitätsmedizin Berlin | Berlin | 10117 | Germany | |||
| Institut für Medizinische Psychologie, Leipziger Str. 44 |
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| ID | Term |
|---|---|
| D014786 | Vision Disorders |
| ID | Term |
|---|---|
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D005128 | Eye Diseases |
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| placebo stimulation | Device | a clicking sound was presented and the same electrodes montage set-up was used during rtACS and placebo stimulation, except that placebo patients received no current (stimulator turned off). |
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| baseline to 60 days after stimulation |
| Visual Parameters 3 | visual acuity (VA) | baseline to 60 days after stimulation |
| Visual Parameters 4 | contrast vision | baseline to 60 days after stimulation |
| EEG parameters | EEG power spectra | baseline to 60 days after stimulation |
| Magdeburg |
| 39120 |
| Germany |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |