OUR Approach — DBS-F

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Andres Lozano, a neurosurgeon at University of Toronto and Scientific Founder of Functional Neuromodulation, originated the concept of treating memory disorders using deep brain stimulation (DBS) while treating a patient suffering from morbid obesity.  In this patient, DBS stimulation of the hypothalamus and fornix unexpectedly produced significant improvement in memory — Annals of Neurology in 2008.

Since this initial finding, Dr. Lozano and colleagues at Toronto Western Hospital completed a Phase I pilot study to test the safety and potential cognitive benefit of DBS in the fornix (DBS-f) in mild Alzheimer's patients. The DBS target in Alzheimer’s, the fornix, is a large arch-like bundle of 1.2 million axons that connects the hippocampus to other parts of the limbic system, a group of interconnected structures in the brain that mediate emotions, learning and memory. The fornix is a major inflow and output pathway in the brain’s memory circuit and is one of the first areas of the brain affected by Alzheimer's. With the fornix critical to memory function, DBS of this structure may drive critical neural activity.

The results from the pilot study in six patients indicate that DBS-f may drive neural activity and modulate the memory circuit in patients with early Alzheimer's. While patients in this pilot study remained on medication during DBS treatment, based on the results of this trial, researchers hypothesize DBS-f may slow the rate of cognitive decline over 12 months relative to the expected rate of change in mildly impaired patients. Study data also show that DBS-f may produce improvement in glucose metabolism in brain areas associated with Alzheimer's, possibly indicating an increase in energy utilization and function of these areas. The researchers conclude that memory circuits can be safely accessed with DBS. The study was published in the Annals of Neurology in 2010.

A follow-up paper evaluating the relationship between brain metabolism and clinical outcomes in that study was published in Archives of Neurology.  That publication reported increased glucose metabolism in key brain networks after stimulation, indicating an increase in neuronal activity and better functional connectivity in areas affected by Alzheimer’s.  At one year, this increase in brain metabolism correlated with better outcomes in cognition, memory and quality of life. 

For more information about the scientific rationale for this approach, please review Deep Brain Stimulation: A Novel Strategy for Treating Alzheimer's Disease, published in Innovations In Clinical Neuroscience.

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

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