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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
90
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.
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.
Klinik für Neurologie, Charité Campus Mitte, Universitätsmedizin Berlin
Berlin, Germany
Klinische Neurophysiologie & Abteilung Augenheilkunde, Universitätsmedizin Göttingen
Göttingen, Germany
Augenklinik Kassel am Klinikum Kassel GmbH
Kassel, Germany
Inst. f. Medizinische Psychologie, Universitätsklinikum Magdeburg
Magdeburg, Germany
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.
Time frame: Baseline - 8 weeks after stimulation; First follow-up 2 days after treatment course; Second follow-up 8 weeks after treatment course
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.
Time frame: Baseline - 8 weeks after stimulation; First follow-up 2 days after treatment course; Second follow-up 8 weeks after treatment course
EEG parameters
EEG power spectra
Time frame: 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
Time frame: Baseline - 8 weeks after stimulation; First follow-up 2 days after treatment course; Second follow-up 8 weeks after treatment course
Visual acuity (VA)
Time frame: 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
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Time frame: Baseline - 8 weeks after stimulation; First follow-up 2 days after treatment course; Second follow-up 8 weeks after treatment course