Functional Neuromodulation has treated the first US patient with a deep brain stimulation (DBS) system in a randomized, double-blind, controlled trial.
The trial, named Advance, has implanted the first patient at Johns Hopkins to demonstrate the safety and clinical benefit of DBS of the fornix (DBS-f), an inflow and output pathway in the brain’s memory circuit, for patients with mild Alzheimer’s.
The 20 patient-based trial will compare the effects of DBS turned on to those observed with the system turned off.
The patients will undergo regular physiological, psychological and cognitive assessments for 12 months at which time those patients in the off group will be eligible to have the system activated, claims the company.
The study will also evaluate brain imaging measures of changes in glucose metabolism and the size of key structures involved in memory, at multiple time points.
In addition to the participation of five North American research centers, the University of Pennsylvania has joined the study.
Penn Memory Center assistant director and neurology assistant professor David Wolk said the pre-clinical testing has suggested that DBS may result in physiological changes that could alter disease progression.
"ADvance will help us to determine whether stimulation of the fornix can drive activity in the memory circuit to improve memory and lead to better clinical outcomes," Wolk added.