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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 D 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.
Obsessive-Compulsive Disorder (OCD) is a highly debilitating condition with a lifetime prevalence of 2%–3%, and a notable percentage of patients (40-60%) who have partial or no response to medications.
According to the DSM-IV-TR, obsessions are repetitive, intrusive, and distressing thoughts, ideas, images, or urges that often are experienced as meaningless, inappropriate, and irrelevant, and persist despite efforts to suppress, resist, or ignore them. Compulsions are repetitive, stereotyped behaviors and/or mental acts that are used to diminish the anxiety and distress associated with the obsessions.
BrainsWay OCD offers an effective, safe and non-invasive treatment that uses Deep Transcranial Magnetic Stimulation to treat OCD. The treatment performs magnetic stimulation of frontal brain structures and networks including the cingulate cortex and brings significant improvement to patients suffering from OCD. It has many advantages over other treatment options, as it is an outpatient procedure and does not require hospitalization or anesthesia, is generally well tolerated and entails minimal systemic side effects.
BrainsWay OCD therapy can significantly improve patients suffering from OCD, as was demonstrated in the positive final results of BrainsWay’s Deep-TMS study, the only multicenter trial in OCD patients ever conducted.
The multicenter study demonstrated that after six weeks of treatment, there was a statistically significant improvement in the primary endpoint results for the active treatment group when compared to sham (p=0.0127). The improvement was maintained one month after the end of treatment at week 10. The primary outcome measure of this study was the OCD Yale-Brown Obsessive-Compulsive Scale (Y-BOCS), the gold standard measure of OCD symptoms severity. Importantly, 38.1% of patients in the active group achieved a response of more than 30% reduction in symptoms severity as measured by Y-BOCS, compared with just 11.1% in the sham group (p=0.0033). Moreover, 54.8% of patients in the active group achieved a partial response of more than 20% reduction in symptoms severity, versus just 26.7% in the sham group (p=0.0076).
BrainsWay OCD treatment is approved by the CE for treating OCD patients.
Behavioral therapy (BT), cognitive behavioral therapy (CBT), and medications are first-line treatments for OCD. Psychodynamic psychotherapy may help in managing some aspects of the disorder. The American Psychiatric Association notes a lack of controlled studies demonstrating that psychoanalysis or dynamic psychotherapy is effective “in dealing with the core symptoms of OCD.” The fact that many individuals do not seek treatment may be due in part to stigma associated with OCD.
The specific technique used in BT/CBT is called exposure and ritual prevention (also known as “exposure and response prevention”) or ERP; this involves gradually learning to tolerate the anxiety associated with not performing the ritual behavior.
It has generally been accepted that psychotherapy, in combination with psychiatric medication, is more effective than either option alone. However, more recent studies have shown no difference in outcomes for those treated with the combination of medicine and CBT versus CBT alone.
Medications as treatment include selective serotonin reuptake inhibitors (SSRIs) and the tricyclic antidepressants, in particular clomipramine.
Treatment of OCD is an area that requires significant improvement in prescribing regimens. Benzodiazepines are sometimes used, although they are generally believed to be ineffective for treating OCD; however, effectiveness was found in one small study. In most cases antidepressant therapy alone provides only a partial reduction in symptoms, even in cases that are not deemed treatment-resistant.
The atypical antipsychotics such as quetiapine have also been found to be useful when used in addition to an SSRI in treatment-resistant OCD. However, these drugs are often poorly tolerated, and have metabolic side effects that limit their use. None of the atypical antipsychotics appear to be useful when used alone.
Electroconvulsive therapy (ECT) has been found to have effectiveness in some severe and refractory cases.
For some, medication, support groups and psychological treatments fail to alleviate obsessive–compulsive symptoms. These patients may choose to undergo psychosurgery as a last resort. In this procedure, a surgical lesion is made in an area of the brain (the cingulate cortex). In one study, 30% of participants benefited significantly from this procedure. Deep-brain stimulation and vagus nerve stimulation are possible surgical options that do not require destruction of brain tissue. In the US, the Food and Drug Administration approved deep brain stimulation for the treatment of OCD under a humanitarian device exemption requiring that the procedure be performed only in a hospital with specialist qualifications to do so.
In the US, psychosurgery for OCD is a treatment of last resort and will not be performed until the patient has failed several attempts at medication (at the full dosage) with augmentation, and many months of intensive cognitive–behavioral therapy with exposure and ritual/response prevention. Likewise, in the United Kingdom, psychosurgery cannot be performed unless a course of treatment from a suitably qualified cognitive–behavioral therapist has been carried out.
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 OCD, please contact us at firstname.lastname@example.org