Functional Neuromodulation has implanted the first US patient with a deep brain stimulation (DBS) system in a randomised double-blind controlled trial.
The 20 patient-based trial, named ADvance, will assess 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 procedure, conducted at Johns Hopkins, delivers mild electrical pulses to precisely targeted areas of the brain and slows down the progression of Alzheimer’s disease.
The 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, according to the company.
The study will also assess 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 existing participation of five North American research centers, the University of Pennsylvania has joined the study.
Functional Neuromodulation president and COO Todd Langevin said; “In just two years, we have partnered with expert clinical researchers and assembled a lean team of seasoned professionals that have propelled the company through funding, regulatory requirements, study initiation and significant patient enrollment.”
Penn Memory Centre assistant director and neurology assistant professor Dr David Wolk said the centre believes that the new circuitry-based approach can become a new hope for treating Alzheimer’s.
“Pre-clinical testing has suggested that DBS may result in physiological changes that could alter disease progression,” Wolk said.
“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.”