Deep Transcranial Magnetic Stimulation Coil and Therapy System

In April 2013, President Obama unveiled the “BRAIN” initiative, which called on the scientific community to better understand the human brain in an effort to treat, prevent, and cure neurological diseases. For example, anxiety, depression, substance abuse, and post-traumatic stress are a few pervasive neuropsychiatric diseases that afflict more than 150 million people in developed countries, and approximately 15 million of those are in the U.S.

A joint effort from the National Institute of Neurological Disorders and Stroke (NINDS) and the National Institute on Drug Abuse (NIDA) developed a unique H-coil configuration for a deep therapeutic transcranial stimulation (dTMS) system. This dTMS system is capable of delivering magnetic fields to the deep brain, where it stimulates the limbic system, an important area of the brain modulated by dopamine and implicated in multiple neurological and neuropsychiatric disorders.

Dr. Abraham Zanger, who originally developed the technology at NIDA, left NIH and cofounded the company Brainsway, to which NIH exclusively licensed patents covering the H-coil design and its implementation in therapeutically stimulating the deep brain. the company later engaged the NINDS Technology Transfer Office to put in place a clinical collaboration, the purpose of which was to study the uses of its dTMS system for treating Parkinson’s disease. In this technology transfer transaction, the inventor was able to license from the federal government the technology in which he had played a crucial development role; find market-experienced people with whom to start a company; find multiple national research organizations to collaborate with, including re-engaging with his original collaborators at NIH to initiate a clinical research protocol; and, ultimately market a device that received clearance from the Food and Drug Administration (FDA) under a 510K application.

In July 2011, FDA approval was awarded for the treatment of specific depression disorders, and approval is pending for a variety of other neuropsychiatric disorders. The dTMS system has also been approved in Europe (under the CE mark) for use in treating all forms of clinical depression, bipolar disorder, posttraumatic stress disorder (PTSD), schizophrenia, smoking cessation, Parkinson’s disease, neuropathic pain, Alzheimer’s disease, and autism. Ongoing studies include the use of dTMS in a variety of substance addictions, Tourette’s syndrome, obestiy, anorexia nervosa, ADD/DHD, and stroke rehabilitation. Currently, the system is in use at more than 15 hospitals and care facilities throughout the U.S.

Awardees

NIH - National Institute of Neurological Disorders and Stroke

• Dr. Mark Hallett

NIH - National Cancer Institute

• Heather Gunas

Ben-Gurion University

• Dr. Abraham Zangen

Brainsway, Inc.

• Dr. Yiftach Roth
• Uza Sofer

NIH - Office of Technology Transfer

• Michael Shmilovich