Clinical Research

The New Era in Brain Research

BrainsWay’s* patented breakthrough treatment based on Deep TMS begins a new era in brain stimulation and research. This non-invasive and effective* treatment activates deep brain structures by using directed electromagnetic fields that generate excitation or inhibition of neurons deep inside the brain.

BrainsWay’s technology is based on patents filed by the U.S. National Institutes of Health (NIH) and the company. The treatment has been enthusiastically embraced by the international academic community, with over 60 clinical trials in leading institutions worldwide.

Patented Coil Structure

BrainsWay’s Deep TMS technology is based on the H-Coil, which features a novel patented structure that maximizes electrical stimulation of deep brain regions and includes the following unique features:

  • Coil elements tangential to the head and close to target brain regions
  • Flexible base suited to head shape
  • Convergence of numerous electric pulses from various directions
  • Coil elements parallel to target bundles
  • Location of return paths of electrical impulses remote from target area

BrainsWay’s technology is based on a patent registered by the U.S. National Institutes of Health (NIH). BrainsWay has an exclusive license from the NIH for both the patent and the technology.

Ideal for Research

BrainsWay’s Deep TMS technology includes a double-blind system that enables researchers to easily conduct randomized studies. The system includes smart cards that are randomized between the patients. At the beginning of each treatment, the patient’s individual smart card is inserted into the card reader, automatically activating either the real or the sham coil, which are both located in the patient’s head set. Both coils produce similar scalp sensations and acoustic artifact, so that neither the patient nor the caregiver knows whether the treatment taking place is real or sham.

Can Be Implemented in a Range of Clinical & Neuroscience Studies

BrainsWay’s Deep TMS technology can be used to stimulate a wide variety of brain regions and networks. It can easily be applied to diverse clinical applications by designing coils that target different locations, depths, directionalities & morphologies relevant to target neuronal structures, and usage of different protocols during treatment.

The following is a list of brain regions that have been stimulated in various studies using BrainsWay’s technology:

  •         Lateral and medial prefrontal cortex (PFC) including ventral PFC
  •         Orbitofrontal cortex
  •         Right & left Insular cortex and entorhinal cortex
  •         Anterior cingulate cortex
  •         Posterior cingulate cortex
  •         Lateral and medial motor cortex, including deeper leg motor cortex
  •         Premotor cortex
  •         Supplementary motor area
  •         Precuneus
  •         Right and left temporal cortex structures, including fusiform face area (FFA) & superior temporal sulcus (STS)
  •         Parietal cortex regions
  •         Occipital cortex regions
  •         Auditory cortex
  •         Visual cortex
  •         Cerebellum

Going Deeper for Better Results

Studies have shown that the depth and wide range of brain stimulation significantly and positively impact the results, as is shown in the following quotes:

  • “Many behavioral manifestations of neurological and psychiatric diseases are not solely the result of abnormality in one isolated brain region but represent alterations in brain networks and connectivity.” (Fox et al. Neurolmage 2012(
  • “Deeper (ventral) PFC structures have significantly more connections with other reward system sites compared to superficial PFC”. (Leh et al., 2007)
  • “There is significant inter-individual variability in the exact location of DLPFC sites having functional connectivity with subgenual cingulate “(Fox et al. Neuroimage 2012)
  • “Effective response to standard TMS in MDD is strongly correlated with resting state functional connectivity between DLPFC stimulation sites and subgenual cingulate “(Fox et al. Biol. Psychiatry 2012).
  • “Individualized targeting becomes less important with larger stimulation field sizes” (Fox et al. Biol. Psychiatry 2012)

FDA Cleared for Major Depressive Disorder (MDD) and Obsessive Compulsive Disorder (OCD) Treatments 

BrainsWay’s treatment has been cleared by the FDA for Major Depressive Disorder (MDD) patients who tried any number of antidepressants with no improvement (in the current depressive episode). The FDA indication is based on a unique long-term 16-week double-blind, placebo-controlled, multicenter study which enrolled over 200 subjects, and reported a marked decline in HDRS-21 scores, as well as significant remission (32.6%) and response (38.4%) rates at the primary endpoint of the study after 4 weeks of acute treatment. In the study, BrainsWay’s treatment was proved to be safe, and the treatment was well tolerated by the majority of the study subjects. FDA 510(k) No. K122288

BrainsWay Deep TMS is indicated by the FDA as an intended adjunct treatment for adult patients suffering from Obsessive-Compulsive Disorder (OCD). If your patients have been diagnosed with Obsessive Compulsive Disorder (OCD) and are currently being treated with medication or psychotherapy, BrainsWay OCD treatment may offer an additional treatment option to help them achieve wellbeing. FDA De Novo No. DEN170078

CE Cleared for Multiple Brain Disorders

BrainsWay’s treatment has CE marks* for the following brain disorders:

  • Alzheimer’s disease
  • Autism
  • Bipolar disorder
  • Chronic pain
  • Major depressive disorder
  • Parkinson’s disease
  • Posttraumatic stress disorder (PTSD)
  • Schizophrenia (negative symptoms)
  • Stroke rehabilitation
  • MSC (Multiple Sclerosis)
  • OCD (Obsessive Compulsive Disorder)
  • Smoking cessation