About Deep Brain Stimulation (DBS)
The ADvance Study is researching the use of deep brain stimulation of the fornix (known as DBS-f), a place in the brain that plays a central role in memory, in people with Alzheimer’s disease. DBS-f is an adjustable therapy that uses an implanted device that electrically stimulates the brain. The system includes a neurostimulator, similar to a heart pacemaker, that is implanted beneath the skin in the patient’s chest and two attached wires that deliver electrical pulses directly to a specific area in the brain.
More than 85,000 people worldwide have received DBS therapy, with stimulation of other areas of the brain to treat other medical conditions. The ADvance study is using a DBS system produced by Medtronic. Medtronic DBS technology was first approved by the FDA in 1997 and is now used for the treatment of Parkinson’s Disease and Essential Tremor, Obsessive-Compulsive Disorder* and Dystonia. * The use of DBS in the fornix for Alzheimer’s is investigational (being studied) and not currently approved by the FDA.
The neurosurgeons participating in ADvance have extensive experience with DBS surgery. All subjects in the study will have a DBS-f system implanted, with the stimulation device turned on for half of the subjects, and off for half. For those with the device turned off at the start of the study, they will have it turned on after 12 months. All study participants will be regularly assessed for 18 months to measure their rate of Alzheimer’s progression. The DBS-f system or certain components of the system are likely to remain in the body of study participants for the rest of their lives.
*Humanitarian Device Exemption: The effectiveness of this device for this use has not been demonstrated.
Caution: Investigational Device. Limited by Federal law to investigational use.