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.
Neuropathy is common in the diabetic population, affecting approximately 50% of patients with long-lasting diseases. The most common type is symmetric distal sensorimotor polyneuropathy, in which pain is a dominant symptom.
Although painful neuropathy responds to antidepressants, anticonvulsants and opioid agonists, these drugs are often ineffective or can induce severe adverse effects. Hence, to manage this condition effectively, there is a need to seek other safe and effective therapeutic options.
Invasive neurostimulation techniques are already used successfully to treat drug-resistant neuropathic pain, including brain stimulation and epidural motor cortex stimulation.
BrainsWay’s Treatment for Chronic Pain
BrainsWay’s* treatment offers an effective*, safe and non-invasive treatment that uses Deep Transcranial Magnetic Stimulation (TMS) to treat chronic pain. The treatment performs magnetic stimulation of brain structures and networks related to chronic pain. It can be used to modulate cortical excitability and inhibit pain perception in the brain to bring 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*.
Standard TMS coils (such as the figure-of-eight coil) permit stimulation of only superficial cortical regions of the human brain, because the higher stimulus intensities required to affect deeper brain areas increase the risk of adverse effects. BrainsWay’s H-coil allows brain stimulation without significantly increasing the intensity of induced fields in superficial cortical regions. The H-coil can therefore be used to stimulate the lower-limb motor cortex, an area that lies in interior sections of the motor area, tucked deep in the medial longitudinal fissure.
A recent study used Deep TMS over the deeper leg motor cortex to treat patients suffering from diabetic neuropathic pain (see link below). Twenty-five patients were enrolled and treated with the HMMC-coil, which is designed for effective activation of neuronal structures in the motor cortex, including the deeper structures of the leg motor cortex, with hemispheric symmetry. Patients were randomly assigned to receive daily active or sham Deep TMS for 5 consecutive days. Sham/active treatment sessions were applied in crossover design with intervals of 5 weeks.
The analgesic effect of Deep TMS therapy (real vs. sham) was evaluated by measurements of visual analogue scale (VAS) and the nociceptive flexion RIII reflex.
Repeated measures ANOVA showed a significant decrease subjective pain sensation (as measured by the VAS) in the active but not the sham group (p=0.01); and in RIII reflex threshold (p<0.01) following active but not sham treatments. The improvements in both VAS scores and RIII reflex thresholds were preserved 3 weeks after the last active session.
BrainsWay Deep TMS therapy is approved by the CE* and by ANIVISA for treating chronic pain.
Click to view study
* Click here for references
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 email@example.com
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.