DBS Technology

Deep brain stimulation (DBS) uses a surgically implanted medical device, similar to a cardiac pacemaker, to deliver mild electrical pulses to precisely targeted areas of the brain. DBS therapy was first approved in Europe in 1995 and in the United States in 1997. The therapy is currently licensed in Canada and approved in other regions, including the European Union and the United States, for the treatment of the disabling symptoms of essential tremor and advanced Parkinson's disease. It is also approved for the treatment of refractory epilepsy in the U.S. and Europe. The therapy is also approved for the treatment of severe, treatment-resistant obsessive-compulsive disorder in the European Union, Australia and in the United States under an HDE1. More than 135,000 people worldwide have received DBS therapy.

In the last several years, Dr. Andres Lozano, a neurosurgeon at University of Toronto and scientific founder of Functional Neuromodulation, originated the concept of treating memory disorders using DBS while treating a patient suffering from morbid obesity. In this patient, DBS stimulation of the hypothalamus and fornix was associated with an unexpected observed improvement in the patient’s memory — Annals of Neurology in 2008. This was followed by a pilot study which laid the groundwork for evaluating DBS in Alzheimer’s disease in ADvance I. The results from ADvance I led to the approval (CE mark) of DBS for Alzheimer’s disease in Europe. ADvance II is being conducted to support U.S. regulatory approval.

Humanitarian Device in the U.S.: The effectiveness of this device for the treatment of obsessive-compulsive disorder has not been demonstrated..

CAUTION — Investigational device. Limited by Federal law to investigational use.