Angelo Vertti, 18 de setembro de 2022

The respective p-values are reported with p<0.05 considered as significant. Computer simulations of current flow in the intact brain suggest that a considerable amount of current enters the skull through the eye and optic nerve (Fig 3A), affecting brain regions close to the eye socket. For the first time since 2016, I was able to see vivid colors. The reason we selected a minimal dose treatment for sham controls is that this equalizes the expectations in both groups. I want to express my thanks to everyone a Restore Vision Clinic for what they did for me. Since there were no center effects (neither as the main factor nor as an interaction with the treatment arm), nor dependencies of BASELINE results for the primary endpoint, the primary data analysis and secondary between-group comparisons were performed for the pre-defined hypothesis with a one-sided U-test (p-value<0.05). My message is: "Don't wait." For the first time since 2016, I was able to see vivid colors. Visual field improvement induced by rtACS was associated with EEG power-spectra and coherence alterations in visual cortical networks which are interpreted as signs of neuromodulation. ), 2 sec bins, and baseline correction. ClinicalTrials.gov {"type":"clinical-trial","attrs":{"text":"NCT01280877","term_id":"NCT01280877"}}NCT01280877. I owe everything to Dr. Anton Fedorov and Dr. Julia Chibisova, I have my dream back! We performed computer simulation to estimate the amount of current that was being delivered to components of the visual system in a 40-yrs old male control subject. 10.1016/B978--444-53355-5. . 2 Visual acuity was calculated for all patients with better visual acuity than counting fingers (logMAR = 3). Therefore, the current flow simulation was done only with one electrode, representing all other electrodes. I have been diagnosed with advanced glaucoma. The simulation represents a quasi-static solution of the Maxwell equations and serves as an approximation for current density estimation of one time sample during rtACS when the cathode and anode reaches its maximal current intensity value. The trial flow diagram and study design are shown in Fig 1A and 1B. Subjective change was evaluated with the NEI-VFQ scales visual field defect and related impairments and general health and mental distress at POST and FOLLOW-UP and compared between groups. Institute for Biometry and Medical Informatics, Otto-von-Guericke University Magdeburg, Magdeburg, Germany. We spent two weeks in Berlin receiving the treatment and the very excellent, attentive care of both Dr. Fedorov and Dr. Chibisova. The rtACS-treated group had a mean improvement in visual field of 24.0% which was significantly greater than after sham-stimulation (2.5%). However, in contrast to what was seen in a previous study [14], the objective improvement of VFs did not correlate significantly with subjective measures, i.e., there was a mismatch between both levels of analysis which can be attributed to the fact that only a small proportion of subjective vision can actually be explained by objective VF results as previously discussed [10]. As recently shown by patients with optic nerve damage who suffer from desynchronization of spatial and temporal processing deficits of their brain functional networks [12, 29] the therapeutic effects of rtACS may be mediated by re-synchronizing the brain networks, which were desynchronized by the vision loss. However, considering that phosphenes may contribute to a placebo effect, it cannot be ruled out that patients in the rtACS-group who experienced more significant visual phenomena during stimulation might have had a greater feeling of that a powerful treatment was occurring than those who only experienced a flash once a minute. The https:// ensures that you are connecting to the sharing sensitive information, make sure youre on a federal Stability of VF defects was ascertained by comparing VFs at BASELINE with those obtained during the screening visit 2 weeks earlier. Therefore, the current flow simulation was done with only one electrode, representing all other electrodes. The investigator administering the treatment was aware of the group identity but was instructed not to reveal to the patients which treatment they received. The continuum of detection and awareness of visual stimuli within the blindfield: from blindsight to the sighted-sight, Vision restoration training in glaucomaA prospective, double-blind, randomized, placebo-controlled clinical trial, Disturbed temporal dynamics of brain synchronization in vision loss, Dynamic reorganization of brain functional networks during cognition, Transcranial Alternating Current Stimulation Modulates Large-Scale Cortical Network Activity by Network Resonance. Due to the possibility that patients with monocular impairment may not experience a severe reduction in vision-related QoL, an exploratory subgroup analysis of patients with binocular loss, i.e., excluding those with an intact fellow eye, was conducted. To assess functional interactions between brain regions coherence was analyzed indicating coupling between two signals as a function of frequency [19]. In the first trial a mean percentage increase ( standard deviation) of 65.61 104.35 was observed in the rtACS-group (n = 19) and 16.93 31.22 in the sham-group (n = 14). Right sub-figure: Scatter plot showing the relation between change in alpha band coherence at the occipital area of interest and change in detection accuracy in total visual field (primary outcome measure). In the sham-group there was a significant increase in the NEI-VFQ general health and mental distress scale (p = 0.01) at POST with no significant difference between groups (p = 0.30). Accessibility In prior rtACS-studies, the sham-condition was an auditory sound that mimicked current delivery [1415]. Between-group differences of the BASELINE diagnostic values were not statistically significant in any measure (Wilcoxon-Mann-Whitney U test, two-sided). Concerning mean VF size obtained in kinetic perimetry, a clinically negligible but still significant increase was observed in both groups (median change after rtACS 4.3% [-0.3%, 11.9%]; p = 0.036, and after sham-stimulation 4.8% [-1.5%, 16.1%], p = 0.040). My husband is very happy with the treatment. Analyzed the data: AL SK CG MB MD. full function, partial function and absolute vision loss) were determined by superimposing repeated HRP measures to determine which visual field regions are intact, partially damaged (residual I and residual II) and absolutely impaired (absolute defect). The primary outcome measure for efficacy was super-threshold visual fields with 48 hrs after the last treatment day and at 2-months follow-up. For further explanations, see text. I was so impressed with my results from June 2017 that I returned this May 2018 and again am thrilled with my results. Eichelbaum S, Dannhauer M, Hlawitschka M, Brooks D, Knsche TR, Scheuermann G. Visualization simulated electrical fields from electroencephalography and transcranial electric brain stimulation: a comparative evaluation, A model of the electrical volume conductor in the region of the eye in the ELF range, Evaluation of two treatment outcome prediction models for restoration of visual fields in patients with postchiasmatic visual pathway lesions. After the first rtACS session, an increase of spectral power was observed in theta, alpha and beta frequency bands in both the occipital and frontal regions. Indeed, one would not expect that patients generate a hypothesis on their own that fewer phosphenes were less effective. Therefore, we adopted a conservative approach of considering up to 10 percent drop-out and planned to recruit 45 patients per group. Mean fixation was within the central area of 1 horizontally and 0.5 vertically for both groups at all time points (S1 Fig). Ask Our Physicians For Your Evaluation The occipital coherence change after the first stimulation session was significantly correlated with final treatment outcome (Fig 2C). Here, 10 daily rtACS sessions increased light detection performance and improved patient-reported vision-related QoL which was moderately correlated with VF gains [15]. Department of Neurology, Charit-Universittsmedizin Berlin, Berlin, Germany, 3 To assess the relationship between EEG and primary outcome measures, Spearman correlation coefficient was used. During my time at the clinic, I met several individuals from around the world who were told - sorry there is nothing we can do to help. This study was funded in part, by the German Federal Education and Research Ministry, grant ERA-net Neuron (BMBF 01EW1210) to BAS and CG, by the University of Magdeburg (LOM-grant to MB), by the German Research Foundation, Grant number BR 1691/8-1 to SS, and by the National Institute of General Medical Sciences of the National Institutes of Health (USA) under grant number P41 GM103545-17 to MD, and by EBS (Germany). Brain functional connectivity network breakdown and restoration in blindness, Uncovering the connectivity of the brain in relation to novel vision rehabilitation strategies. By superimposing HRP computer campimetric VF charts of three repeated measurements, VF areas were categorized as intact (perfect stimulus detection at a given location, white spots), partially damaged/relative defect (inconsistent stimulus detection, grey spots), and absolutely impaired areas (no stimulus detected, black spots). Sahraie A, Trevethan CT, Macleod MJ, Weiskrantz L, Hunt AR. The size of the absolute defect significantly decreased after rtACS when compared to sham-treated patients ( = 190.201, df = 1, p<0.0001) (S2 Fig). Possible side effects were evaluated by a semi-structured daily interview that included queries on mild headache, discomfort, and vertigo as expected minor adverse events. The absolute change of HRP fixation accuracy and percentage of responses outside the valid response window in HRP were considered as reliability parameters. Several open questions should be addressed in future studies. Sabel BA, Henrich-Noack P, Fedorov A, Gall C. Vision restoration after brain and retina damage: the "residual vision activation theory". None of the participants reported discomfort during the stimulation. After therapy in Berlin, I have seen, There are no words to express the immense appreciation to, Dr. Fedorov and Julia. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Visualization of simulated electrical fields during rtACS: current density maxima on eye/optical nerve (A), brain tissue surface (B) and in the volume (C). Using these means and standard deviations in a sample size calculation ( = 0.05, two-sided, power 1 = 0.80) for a two-sample t-test (Satterthwaite version) with nQuery Advisor 7.0 resulted in 41 patients per group for the first trial and 36 patients per group for the second trial. Table 1 summarizes the demographics and lesion variables. This subject dropped out of the study. They've given me hope. The .gov means its official. We cannot thank them enough and we're so grateful. My teenage son experienced a brain hemorrhage more than three years ago and is now severely visually impaired. I was very impressed with the professional care that I received at the Clinic. Unspecific power increases after 10 days sham-stimulation were only found in the theta power-band, which may reflect fatigue during the course of the experiment. In subjects with binocular vision impairment, NEI-VFQ measures of vision-related QoL indicated improved ratings of NEI-VFQ scales VF defect and related impairments after rtACS as well as improved ratings of general health and mental distress after sham. The study design was prospective and double blind; neither the patients nor the diagnostic examiners were aware to which treatment arm the patient belonged. I am pleased to say that Alex is seeing great improvements which seem to be getting better all the time. (B) Study design with diagnostic and treatment visits. A major proportion of the current appears to leave the skull through the foramen magnum and down the spinal cord into the ground. Secondary outcome measures were near-threshold visual fields, reaction time, visual acuity, and resting-state EEGs to assess changes in brain physiology. 2023 Fedorov Restore Vision Clinic. This is one of the reasons that more than 75% of our patients see improvement in their vision after a single course of treatment. My life made it so much better. Randomization was done after BASELINE assessment. All subjects answered the questionnaire, but not sure answers were given by a large number of subjects. (A) Patient flow for cases included in the primary outcome measure analysis. (A) Primary and secondary analyses of VF outcome between- and within-groups after rtACS and sham-stimulation bar charts of primary (first upper graph) and secondary parameters of VF diagnostics measured using HRP and standard-automated static and kinetic perimetry. The beneficial functional consequence of rtACS for visual perception may possibly be explained by retinofugal entrainment and brain functional connectivity modulation [12, 16]. The sample size calculation was based on results of two earlier pilot studies at the Institute of Medical Psychology (University of Magdeburg) considering similar patients and equivalent stimulation schemes, i.e., rtACS- and sham-groups as in the present trial. Here, rtACS-patients reported a significant increase in NEI-VFQ visual field defect and related impairments scale (p<0.01) at FOLLOW-UP with no significant difference between groups (p = 0.40). and transmitted securely. (C) Another area of locally increased current density can be found at the brain stem and lower cerebellum. Gall C, Silvennoinen K, Granata G, de Rossi F, Vecchio F, Brsel D, et al. The before and after field tests showed new fields of vision opening up. Merlet I, Birot G, Salvador R, Molaee-Ardekani B, Mekonnen A, Soria-Frish A, et al. The EEG data were analyzed in 3 steps. Eye-tracking fixation accuracy while performing a visual detection task in HRP, shown as mean vertical and horizontal fixation position in degrees of visual angle in the visual field. This is an open access article distributed under the terms of the, GUID:B3803620-1D47-4E7F-9818-114CB280F2F0, GUID:6B6E9F53-631A-44A9-9CE3-B2A5E228018D, GUID:A39437F6-54F7-4E68-968E-5330CA543F75, GUID:7B62DEA3-67EF-494D-BBC1-76689296703E, GUID:AFF85773-D306-479D-AB5F-02256CF23178, GUID:A307F474-CD9E-405F-9F71-39B03D19C9E9, GUID:489A8FE1-2393-401D-B62E-F0D796C93FF8, {"type":"clinical-trial","attrs":{"text":"NCT01280877","term_id":"NCT01280877"}}, Optic nerve disease and axon pathophysiology, Vision- and health-related quality of life in patients with visual field loss after postchiasmatic lesions, Visual impairments in the first year after traumatic brain injury. 6,529,759. In 1873, Henri Dor performed one of the earliest experiments using electrical stimulation for the treatment of eye diseases, including amblyopia, retinochoroiditis, glaucoma, and optic atrophy [ 1 ]. I will be going back for a second round! A fast threshold strategy was used to determine threshold values at 66 positions within the 30 visual field. With the 10 sessions complete, with the brain training that goes with it, I feel like my old self again. Inside the skull, highest current densities were observed in high conductive cerebrospinal fluid (CSF) inferior to the brain stem (Fig 3C), which indicates that most of the current flows along the shortest path of lowest resistance at the skull base within CSF liquor. High vs. low defect depth was defined as stimulus detection rates below vs. above 30% inside the VF defect. Department of Clinical Neurophysiology, University Medical Center, Georg-August University, Goettingen, Germany, 5 ", Fedorov Restore Vision ClinicPrenzlauer Allee 9010409 Berlin (Germany). Our treatments helpvisually impairedpeople improve their ability to see the world around them. The proposed mechanism of action is neuromodulation of oscillatory brain activity towards a more synchronized EEG via entrainment of specific stimulation frequencies [1011], and the reorganization of brain functional connectivity networks [12] is considered to be a novel and promising avenue for visual rehabilitation [13]. In other words, despite lower overall alertness, visual processing to (smaller) visual stimuli was faster. There was also an increased current density magnitude at the lower cerebellum and lower brain stem (Fig 3B and 3C). Eventually, he spent two weeks in Berlin and received therapy with a positive experience. hbspt.cta._relativeUrls=true;hbspt.cta.load(4008268, '66ae09b5-4df7-45d5-b6a2-4f595e67759d', {"useNewLoader":"true","region":"na1"}); During the past 20 years, we've treated over 9,000 patients and gained invaluable experience to successfully apply our unique electrical stimulation therapy - The Fedorov Restoration Therapy - to achieve the best results for patients suffering from optic nerve damage, retinal dystrophies or brain disorders. I can't say how much I appreciative about this place. It seems that JavaScript is disabled in your browser. I just finished it and gained some improvement. Table 3 summarizes the results of the trial. A systematic search for a means to improve such vision loss is urgently needed. I need weaker glass and my glaucoma specialist says I appear to be stable. LORETA). I was told from multiple doctors that the damage is permanent and untreatable. The Restore Vision Center is an excellent facility! He visited many doctors. In fact, performance change in HRP correlated negatively with changes in deviations from fixation during eye-tracked HRPs, i.e. UK doctors told us there was no hope of recovering Alex's sight from optic neuritis. For full functionality of this site it is necessary to enable JavaScript. Vision loss after optic neuropathy is considered irreversible. Eyes with intact vision or complete blindness were not considered. I recently completed the treatment. Although the simulation model does not consider the extent of optic nerve damage the results provide meaningful insights indicating that most of the current affect frontal parts of the brain including eyeball and optic nerve while only low levels were found in the visual cortex. Eight patients had two concomitant diagnoses of optic nerve atrophy. Non-invasive electric current stimulation for restoration of vision after unilateral occipital stroke, Age (years), mean standard error mean (SEM), Detection accuracy defective VF sectors (%), Reaction time HRP defective VF sectors (ms), Mean threshold, static perimetry (whole VF, dB), Mean eccentricity, kinetic perimetry (degree), Mean VF size, kinetic perimetry (square degree), Detection accuracy in whole visual field, %, Detection accuracy in defective visual field sectors, %, Detection accuracy within 5 visual field, %, RT in defective visual field sectors (ms), repetitive transorbital alternating current stimulation. In February 2016, I lost sight in my left eye, and my dreams of boxing were gone. I am thankful that I was invited for this treatment to help restore my vision. About 2 of 3 patients treated with rtACS reported being satisfied with the treatment even though only 1 of 3 patients was aware of vision improvements. Middle sub-figure: After sham stimulation a significant power increase was observed for only the theta band (Z = 3.147, p = 0.002). The sample sizes at each study center were as follows: Charit Berlin (n = 33), Otto-von-Guericke University Magdeburg (n = 31), and Department of Ophthalmology, Georg-August University of Goettingen/ Eye Clinic Kassel (n = 18). Patients were informed to which group they belonged only after the FOLLOW-UP tests, and all sham-stimulation patients were offered rtACS. I was diagnosed with Retinitis Pigmentosa at a very early age. In a darkened room, the patient was viewing a 17" monitor from a chin-head-rest at a distance of 42 cm. Transient vertigo was reported by two rtACS-subjects in a total of five sessions and one sham-subject experienced persistent vertigo for 0.5 hrs after each session. Received 2015 Nov 15; Accepted 2016 May 10. Coherence was calculated for each pair of channels ij and defined as follows: In this equation S denotes the spectrum of signals from two EEG channels i and j, for a given frequency bin f. Changes in spectral power of oscillatory brain activity and strength of functional connectivity over the visual cortex after the first stimulation session were then related to the primary outcome measure. Before These improvements were associated with increased alpha-power at occipital sites in resting-EEGs [14,16] and increased neuronal synchronization of functional connectivities between the occipital and frontal regions [12]. Psychometric properties of the National Eye Institute-Visual Function Questionnaire (NEI-VFQ): NEI-VFQ Field Test Investigators, Nonlinear multivariate analysis of neurophysiological signals. For binocular defects the value of both eyes was averaged. It was a hopeless experience and. FOLLOW-UP comparisons were calculated separately for each treatment arm using Wilcoxon matched-pairs signed rank tests. The percent change over BASELINE was determined at 48 hrs (minimum interval) after the last stimulation day (i.e., the 10th stimulation session) (POST) and at 2 months FOLLOW-UP (FU) for each endpoint as 100*(POST resp. Our Therapy combines the science of ophthalmology and neurology to help restore lost eyesight from optic nerve damage. Target stimuli (size: III/4mm2, white, luminance: 318 cd/m2/ 0db, duration: 0.2 sec) were presented on a background with constant luminance of 10cd/m2. Kasten E, Wst S, Behrens-Baumann W, Sabel BA. One circular electrode (height/diameter: 3/10 mm, conductivity: 1.5 S/m) was placed above the subject's right eyebrow and a return electrode was modeled as the last axial slice of the neck region (SCIRun software, current injection: +/-0.5 mA [21]. It may be argued that visual improvements after rtACS can be explained by perceptual learning due to repeated testing. Smaller current density magnitudes are present in gray matter and white matter tissues of the brain (Fig 3C (right)) peaking in the frontal and lower cerebral regions. Wrote the paper: CG AA BAS SS SAB. The Hodges-Lehmann effect estimator and 95%-confidence intervals (CI) are reported. Performance in these tests remained largely unchanged in both groups. For example, visual acuity did not change significantly (Table 3). the contents by NLM or the National Institutes of Health. Furthermore, we would like to thank Electrical Geodesics Inc. (EGI) for providing multi-modal imaging data (MRI and CT images) to generate a volume conductor model to simulate rtACS. Lacz B, Antal A, Niebergall R, Treue S, Paulus W. Transcranial alternating stimulation in a high gamma frequency range applied over V1 improves contrast perception but does not modulate spatial attention. In May 2017 I suffered from vision loss due to NAION that blurred the vision I had left and made me very ill. According to the prevailing view, tACS entrainment leads to a frequency-specific phase realignment of the endogenous oscillations with the applied alternating current with a subsequent frequency-specific power enhancement [3135]. I just finished it and gained some improvement. Despite his neurologists in London telling us there is nothing that can be done to, "There are no words to express the immense appreciation to each and everyone at this Restore Vision Clinic. I have just been to Berlin for two week's eye treatment. government site. I am extremely happy with the results of my treatment in Berlin. The median between-group difference in percentage detection rate change in the defective VF did not reach statistical significance, (8.2% CI[-5.9%;22.5%, p = 0.131) because this parameter significantly increased in both groups; by 41.3% (CI[31.5; 54.3]) in the rtACS- and 33.2% (CI[23.4; 44.2]) in the sham-group (both p<0.001). Four 10mm Grass gold electrodes (SAFELEAD, Astro-Med, Inc, USA), 2 for each eye, were placed on the skin near the orbital cavity (transorbital), and biphasic square-pulses were applied in bursts (Alpha SYNC stimulator, EBS Germany).

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