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| Name | Class |
|---|---|
| EBS Technologies GmbH | INDUSTRY |
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Visual field areas, which are not absolutely blind, are hypothesized to have some residual capacities that constitute their potential for vision restoration. Vision restoration can be achieved by varies methods including behavioral training and electrical brain stimulation such as transcranial direct current stimulation (tDCS) and repetitive transorbital alternating current stimulation (rtACS) which are able to influence the excitability and activity of cortical areas.
It is hypothesized that transorbital alternating current stimulation (tACS) can improve the residual field of vision in patients with post-chiasmatic lesions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Verum stimulation | Experimental | repetitive transorbital alternating current stimulation (rtACS) |
|
| Placebo stimulation | Sham Comparator | compared to verum stimulation the same electrode montage set-up is used during placebo stimulation, except that placebo patients receive a minimal stimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Verum stimulation | Device | 10 days (2x 5 working days), daily transorbital alternating current stimulation (rtACS) is applied with a device generating weak current pulses in predetermined firing bursts of 2 to 9 pulses. The amplitude of each current pulse is below 1000 µA. Current intensity is individually adjusted according to how well patients perceived phosphenes, e.g. any sensation of flickering light in response to the rtACS stimulation. Stimulation frequencies were between the individual alpha frequency peak and below flicker fusion. |
| Measure | Description | Time Frame |
|---|---|---|
| detection accuracy (%) in visual field measures over baseline | visual stimuli detection accuracy in residual and absolutely defect visual field will be assessed using computer-based high resolution perimetry (HRP) | baseline to 8 weeks after stimulation |
| Measure | Description | Time Frame |
|---|---|---|
| detection accuracy (%) in the intact visual field over baseline | visual stimuli detection accuracy in the intact visual field will be assessed using computer-based high resolution perimetry (HRP) | baseline to 8 weeks after stimulation |
| visual acuity (LogRAD) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bernhard A Sabel, Ph.D. | Univ. of Magdeburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inst. f. Medical Psychology, Univ. of Magdeburg | Magdeburg | 39120 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34219679 | Derived | Raty S, Borrmann C, Granata G, Cardenas-Morales L, Schoenfeld A, Sailer M, Silvennoinen K, Holopainen J, De Rossi F, Antal A, Rossini PM, Tatlisumak T, Sabel BA. Non-invasive electrical brain stimulation for vision restoration after stroke: An exploratory randomized trial (REVIS). Restor Neurol Neurosci. 2021;39(3):221-235. doi: 10.3233/RNN-211198. |
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|
| Placebo stimulation | Device | 10 days (2x 5 working days), daily sham-stimulation with the same electrode montage set-up that is used for verum transorbital alternating current stimulation (rtACS). Minimal sham-stimulation was performed with single bursts (approx. one per min) of electrical currents at a given frequency of 5Hz and individually adjusted current amplitude. |
|
| baseline to 8 weeks after stimulation |
| EEG parameters | entrainment of stimulation frequencies (EEG power spectra) and measures of functional connectivity | baseline to 8 weeks after stimulation |
| conventional perimetry | visual fields obtained by static and kinetic perimetry (average threshold in db, average excentricity in degrees) | baseline to 8 weeks after stimulation |
| reaction time (ms) | average reaction time in ms, measured by computer-based high resolution perimetry (HRP) | baseline to 8 weeks after stimulation |
| ID | Term |
|---|---|
| D012607 | Scotoma |
| D006423 | Hemianopsia |
| D020521 | Stroke |
| D006470 | Hemorrhage |
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D014786 | Vision Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001766 | Blindness |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D001930 | Brain Injuries |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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