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| Name | Class |
|---|---|
| EBS Technologies GmbH | INDUSTRY |
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Aim is to validate that non-invasive brain stimulation can increase cortical excitability in the visual system. The investigators assess if transcranial alternating current stimulation (tACS) can improve visual field size in patients with optic nerve damage. Hypothesis: tACS would improve visual functions within the defective visual field (primary outcome measure).
In addition, the correlation between the brain-derived neurotrophic factor (BDNF) or other plasticity markers are correlated to the improvement of the visual field after stimulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Verum stimulation | Experimental | Complete treatment with transorbital alternating current stimulation (tACS) |
|
| Sham stimulation | Sham Comparator | Same electrode montage set-up is used during tACS- and placebo-stimulation. Sham stimulation condition consists of minimal treatment with low intensity/few impulses tACS. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tACS | Device | Transorbital alternating current stimulation (tACS) is applied with a multi-channel device with paraorbital montage of 4 stimulation electrodes generating weak current pulses in predetermined firing bursts of 8 to 14 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 | Central visual fields assessed with computer-based high-resolution perimetry (HRP). Based on such plots, areas of the visual field are characterized as intact, partially damaged or absolutely impaired (blind). Detection accuracy (DA) change in percent above baseline within defective visual field sectors is defined as the primary outcome criterion. | Baseline - 8 weeks after stimulation; First follow-up 2 days after treatment course; Second follow-up 8 weeks after treatment course |
| Measure | Description | Time Frame |
|---|---|---|
| DA change in percent over baseline regarding the damage region of the tested visual field (computer-based high-resolution perimetry) | This parameter includes also intact sectors that are tested with HRP. It is hypothesized that improvements of the primary outcome criterion will outweigh the relative change in intact sectors as measured with HRP. | Baseline - 8 weeks after stimulation; First follow-up 2 days after treatment course; Second follow-up 8 weeks after treatment course |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bernhard A Sabel, Prof. Dr. | Direktor, Institut fĂĽr Medizinische Psychologie, Leipziger Str. 44, D-39120 Magdeburg, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinik für Neurologie, Charité Campus Mitte, Universitätsmedizin Berlin | Berlin | 10117 | Germany | |||
| Klinische Neurophysiologie & Abteilung Augenheilkunde, Universitätsmedizin Göttingen |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27355577 | Result | Gall C, Schmidt S, Schittkowski MP, Antal A, Ambrus GG, Paulus W, Dannhauer M, Michalik R, Mante A, Bola M, Lux A, Kropf S, Brandt SA, Sabel BA. Alternating Current Stimulation for Vision Restoration after Optic Nerve Damage: A Randomized Clinical Trial. PLoS One. 2016 Jun 29;11(6):e0156134. doi: 10.1371/journal.pone.0156134. eCollection 2016. |
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| ID | Term |
|---|---|
| D009901 | Optic Nerve Diseases |
| D020221 | Optic Nerve Injuries |
| ID | Term |
|---|---|
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D005128 | Eye Diseases |
| D020209 | Cranial Nerve Injuries |
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| Sham stimulation | Device | tACS is applied with the same device with equal electrodes set-up procedures but only one of four channels actually delivers current. The current intensity of this channel is individually adjusted (preselected on the side of lesioned eye) according with patient able to clearly perceive single phosphenes or any skin irritation phenomena (like weak sense of needles or vibration) whenever a single pulse is applied. The amplitude of pulses is always below 1000 microA. Current pulses are given as 1 pulse per minute during 25-35 min of session time. Session duration is equal for verum and sham patients. The perception of the single pulses leaves sham patients at the impression that they might receive the verum intervention, but total number of pulses is less than 0,5% of verum tACS. |
|
| EEG parameters | EEG power spectra | Baseline - 8 weeks after stimulation; First follow-up 2 days after treatment course; Second follow-up 8 weeks after treatment course |
| Reaction time change in ms | Reaction time (RT) in HRP | Baseline - 8 weeks after stimulation; First follow-up 2 days after treatment course; Second follow-up 8 weeks after treatment course |
| Visual acuity (VA) | Baseline - 8 weeks after stimulation; First follow-up 2 days after treatment course; Second follow-up 8 weeks after treatment course |
| DA in static and kinetic conventional perimetry | Baseline - 8 weeks after stimulation; First follow-up 2 days after treatment course; Second follow-up 8 weeks after treatment course |
| Göttingen |
| 37075 |
| Germany |
| Augenklinik Kassel am Klinikum Kassel GmbH | Kassel | 34125 | Germany |
| Inst. f. Medizinische Psychologie, Universitätsklinikum Magdeburg | Magdeburg | 39120 | Germany |
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |