A clinical study (“Brain functional connectivity network breakdown and restoration in blindness”) published in the journal Neurology validates non-invasive brain stimulation for restoring partial vision to an impaired eye; the company’s Next Wave system is a non-invasive brain stimulation device designed to expand the visual field of patients with impaired vision from various neurological disorders. Next Wave is approved for sale in Europe.
“Electrical brain stimulation could have the potential to reactivate residual capabilities of brain function,” said Prof. Dr. med. Carl Erb, a German ophthalmologist and glaucoma specialist at the Eye Clinic Wittenberg Platz in Berlin. “We expect that Next Wave therapy will be offered to patients at many additional neuroophthalmologic and neurorehabilitation clinics throughout Europe. Consequently, we are pleased that our institution is among those that are pioneering this medical advance.”In June 2013, EBS announced the results of a multi-center, 82-patient clinical trial of its Next Wave brain stimulation device. About one-half of the clinical trial patients were given a 40-minute treatment protocol for 10 consecutive days with the Next Wave device. With an average increase of 24 percent of the total visual field, Next Wave-treated patients showed significantly better improvements of their total visual field compared with patients in the control group who did not receive Next Wave stimulation. All patients had vision impairment lasting at least six months before the clinical trial started and had exhausted all standard therapeutic options to improve their vision.
“There is an overwhelming and unmet clinical need for treating vision impairment caused by a variety of different neurological disorders, such as neuropathy of the optic nerve. Indeed, three out of five persons who are disabled from impaired vision as a result of optic nerve neuropathy, for example, or brain injury or stroke, are potentially treatable with our Next Wave therapy, which is why we are getting enquiries from patients from not only Europe but also the United States and Asia,” EBS Technologies CEO Ulf Pommereing said.
According to EBS Technologies, Next Wave enables patient-centric revitalization of selective communication paths between neurological cells, which may have been impaired by a trauma, degeneration, tumor resection, etc. The non-invasive therapy using the technology is clinically validated to restore vision impairment by 20 to 30 percent after optical pathologies such as glaucoma and brain dysfunction.
“I now have hope,” said Hans-Joerg Hehli, 58, who lost his central vision due to an eye Infarct, a medical condition involving a relative loss of vision due to damage to the optic nerve, the result of insufficient blood supply.
Hehli had been unable to work as project manager for a machine tool company because of his near-total central vision loss in both eyes. Then, less than two weeks after receiving 10 consecutive days of 40-minute treatments with Next Wave therapy, Hehli said his central vision field improved significantly; using the sophisticated methodology of a computerized visual field analyzer (Octopus 900), doctors confirmed that 33 absolute visual defects have been reduced to two in Hehli’s left eye and 48 “relative visual defects” reduced to 17 in his right eye. Hehli believes he now is at “the start of an improvement process. Given that there was nothing else available to me, I am very thankful and very optimistic.”
The Next Wave device is not yet approved for sale in the United States.