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.
Multiple Sclerosis (MSc) is an inflammatory demyelinating condition of the central nervous system that is mostly considered to be autoimmune. Uncertainty over the cause of this condition implies that it cannot realistically be prevented. Furthermore, no curative treatments are available. Multiple Sclerosis is the most common autoimmune disorder which affects the central nervous system. As of 2008, approximately 2 million people around the world suffer from this condition.
Several disease-modifying drugs have been developed over the last twenty years, which can reduce the number of attacks in the relapsing/remitting form of the disease. However, the extent to which the burden and disability of MS are reduced by use of these drugs is less than clear.
Since a cure is not available, treatment typically focuses on assisting the recovery from attacks, slowing down the progression of the disease and managing MS symptoms. The goal of symptomatic MS treatment is to eliminate or ameliorate symptoms affecting the patients´ functional abilities which impair their quality of life. Many drugs and treatment methods that are widely used in the treatment of MS symptoms are still “off-label” in most countries. Many have not been investigated in proper clinical trials, and have not been approved by health authorities. In addition, several treatment modalities are being used and evaluated in MS centers and specialized hospitals, but the financial impact and legal burdens often prevent pharmaceutical companies from filing an application for licensing. Thus, in the near future health insurance companies may no longer reimburse these off-label drugs, which could harm patients’ ability to access these drugs.
Depressive syndromes occur in about 50% of MS patients demonstrating the need for rigorous treatment of this condition, especially in light of the high rate of attempted and completed suicides. Depression may also restrict the ability of a patient to adhere to a treatment; hence it is important to treat depression to ensure the patients better help themselves manage the disease. The diagnosis of depression, which may be complicated by other MS symptoms like fatigue and cognitive disturbance, requires careful differential diagnosis.
A Cochrane review emphasizes the efficacy of tricyclic antidepressants as well as of serotonin reuptake inhibitors (SSRI) in depressive patients with other medical illness.
BrainsWay’s treatment offers an effective, safe and non-invasive treatment that uses Deep Transcranial Magnetic Stimulation (TMS) to treat MS. The treatment performs magnetic stimulation of brain structures and networks 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* as compared to the harsh and unwanted side effects often caused by the oral medications frequently prescribed for Multiple Sclerosis patients.
In a double-blind sham-controlled BrainsWay Deep TMS study, patients suffering from MS showed significant improvements in measures of fatigue and depressive symptoms, following a 6 week Deep TMS treatment over the motor cortex.
In another double-blind sham-controlled Deep TMS study, it was found the real Deep TMS treatment led to significant improvements in both speed and endurance of walking ability in MS patients.
BrainsWay’s treatment is approved by the CE for treating Multiple Sclerosis patients.
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
You are viewing a page that is not intended for persons in the United States, and includes information about treatment applications that HAVE NOT BEEN CLEARED by the FDA for safety and efficacy.