SBIR Phase I: A Novel, Protective Shield to Increase Safety and Efficacy of rTMS Depression Treatment

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) project is to make non-pharmacological treatment of depression accessible to all patients. According to the World Health Organization, 350 million individuals are affected by depression. In the United States, depression affects 16 million people and it costs $210 billion a year in lost productivity and care for the illnesses related to the disease. Antidepressant drugs are coupled with negative side effects and they are ineffective in 30% of the cases. Repetitive Transcranial Magnetic Stimulation (rTMS) is an FDA approved non-invasive method for depression therapy that consists in the administration of short electromagnetic pulses on patient?s scalp to stimulate regions of the brain involved in mood control. This SBIR Phase I project will help the generation of a new rTMS system that will improve outcomes of depression treatment by stimulating deeper brain cells and reducing the incidence of pain and discomfort associated with current rTMS therapy. The new device will allow broad distribution of rTMS based therapy for both professional clinicians and, in the future, home-care settings. It will avoid reliance on drugs to people affected by depression and it will reduce the impact of depression on society. The SBIR Phase I project proposes to develop and demonstrate the efficacy a new wearable rTMS stimulator device. Although rTMS has a 75% success ratio on depressed patients, 40% of subjects report pain, headaches and discomfort during therapy with current rTMS systems, resulting in a high dropout rate. This is mainly due to poor localization of electromagnetic pulses with commercially available rTMS devices. The new system will combine a new technology that stimulates the brain?s deepest regions involved in depression with unprecedented precision and a new protective shield designed to ward off unwanted heat away from the head, reducing scalp pain and discomfort. The project will develop and validate the efficacy of these components and their integration into a wearable helmet. The project will also demonstrate the superiority of the new device over current gold standard rTMS solutions. The company expects that this research will lead to the generation of a new device capable of treating depression patients through precise stimulation reducing over 40% the unwanted heat, thereby preventing headache and scalp discomfort. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.