This is BrainsWay’s global website. The global website is not intended for persons in the United States and includes information on clinical indications that were not cleared by the FDA, which are subject to further US regulatory review for safety and efficacy. BrainsWay is cleared by the FDA only for patients with MDD who failed to respond to one or more anti-depressants in the current episode, and for patients with OCD as an adjunct treatment.
A brain stroke is the loss of brain function due to a disturbance in the blood supply to the brain. This disturbance is due to either ischemia (lack of blood flow) or hemorrhage. As a result, the affected area of the brain cannot function normally, which might result in motor deficiency in one or more limbs on one side of the body, failure to understand or formulate speech, or a vision impairment of one side of the visual field.
Ischemia is caused by either blockage of a blood vessel via thrombosis or arterial embolism, or by cerebral hypoperfusion. Hemorrhagic stroke is caused by the bleeding of blood vessels of the brain, either directly into the brain parenchyma or into the subarachnoid space surrounding brain tissue
Stroke is the most frequent cause of disability in adults in the industrialized world. About 750,000 individuals in the United States and 1 million individuals in the European Union are affected each year.
Stroke was the second most frequent cause of death worldwide in 2011, accounting for 6.2 million deaths (~11% of the total). Approximately 17 million people experienced a stroke in 2010 and 33 million people have previously had a stroke and were still alive.[t1]
A stroke is a medical emergency and can cause permanent neurological damage or death. An ischemic stroke is occasionally treated in a hospital with thrombolysis (also known as a “clot buster”), and some hemorrhagic strokes benefit from neurosurgery. Treatments designed to recover any lost function are termed stroke rehabilitation, ideally performed in a stroke unit and involving health professionals in the fields of speech and language therapy, physical therapy and occupational therapy.
Stroke rehabilitation should be started as quickly as possible and can last anywhere from a few days to over a year. Most of the function return takes place during the first few months, and then improvement falls off with the “window of opportunity” considered officially by U.S. state rehabilitation units and others to be over after six months, with little chance of further improvement. However, patients have been known to continue to improve for years, regaining and strengthening abilities like writing, walking, running, and talking. Daily rehabilitation exercises should continue to be part of the stroke patient’s routine.
Prevention of recurrence may involve the administration of antiplatelet drugs such as aspirin, control of high blood pressure, and the use of statins. Some people may benefit from carotid endarterectomy and the use of anticoagulants.
BrainsWay’s* treatment offers an effective*, safe and non-invasive treatment that uses Deep Transcranial Magnetic Stimulation (TMS) for stroke rehabilitation. The treatment performs magnetic stimulation of brain structures and networks affected by the stroke, and brings significant improvement to patients.
It is an outpatient procedure and does not require hospitalization or anesthesia, is generally well tolerated and entails minimal systemic side effects*.
A recent sham-controlled study1 used a BrainsWay’s Deep TMS H-coil over the right inferior frontal gyrus to test the efficacy in post-stroke patients suffering from aphasia. The results of this study provide evidence that high frequency Deep TMS over the right inferior frontal gyrus improves naming performance in patients with chronic post-stroke aphasic deficits.
Another sham-controlled study2 tested the feasibility of BrainsWay’s Deep TMS H-coil treatment over the motor cortex to treat stroke patients suffering from deficiencies in lower limb motor functions. It was found that real Deep TMS, as opposed to sham treatment, was associated with a significant improvement in lower limb Fugl-Meyer (p<0.001) and 10 meter test (p=0.05). This effect persisted and even increased over time (at a 4-weeks follow-up). A significant increase in walking speed in 10 meter walk test (p=0.04) was also found after real Deep TMS, as opposed to sham treatment.
1Chieffo R1, Ferrari F, Battista P, et al. Excitatory deep transcranial magnetic stimulation with H-coil over the right homologous Broca’s region improves naming in chronic post-stroke aphasia. Neurorehabil Neural Repair 2014;28:291-298.
2Chieffo R, De Prezzo S, Houdayer E, et al. Deep repetitive transcranial magnetic stimulation with H-coil on lower limb motor function in chronic stroke: a pilot study. Arch Phys Med Rehabil 2014;95:1141-1147
IMPORTANT: BrainsWay* is at different stages of regulatory approval for different indications in different countries. While the status of our regulatory approvals is generally updated on this website, in order to verify whether BrainsWay* is currently approved in your area for the treatment of this indication, please contact us at firstname.lastname@example.org
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