NIH BRAIN Initiative-funded research is key to FDA approval of personalized DBS for Parkinson’s
Deep brain stimulation (DBS) has been used for decades to treat Parkinson’s disease in people who no longer benefit from medications meant to restore levels of the brain chemical dopamine that drives this condition. And although DBS has helped people living with the uncontrollable body movements typical of Parkinson’s, many people have limited benefit and experience side effects.
In a significant breakthrough for these individuals and their families, the U.S. Food and Drug Administration (FDA) has approved a new, personalized version of this technology: adaptive DBS, or aDBS. Reaching this milestone hinged on years of support and research from the NIH’s Brain Research Through Advancing Innovative Neurotechnologies® Initiative, or The BRAIN Initiative®.
The new approval reflects positive results from the Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) trial, a global randomized clinical trial testing aDBS in people with Parkinson's disease. The early research was supported through a public-private partnership involving BRAIN Initiative scientists and Medtronic, a health care technology company that developed and manufactured the investigational Medtronic Summit RC+S (Research Concept + Sensing) Implantable Neurostimulator.
DBS uses a surgically implanted, battery-operated medical device, similar to a heart pacemaker, to deliver a constant level of electrical stimulation to specific areas deep in the brain that control movement. These electrical pulses block the abnormal nerve signals that cause symptoms, providing relief for patients. Unlike traditional DBS, aDBS adjusts stimulation in real time, based on an individual’s unique, everchanging brain signals. The results have been transformative for those individuals participating in the study.
Game-changing advances in innovative neurotechnologies do not happen overnight. These new treatment options reflect years of work led by several BRAIN Initiative-funded teams. For example, in 2015, NIH-funded researchers identified brain signals that can serve as real-time guides to automate these adjustments – alleviating the need for surgeons to do this manually. This team also later showed that combining stimulation in two brain areas worked better than one.
In 2018, another BRAIN Initiative research team developed the first prototype of the new aDBS system that adjusts stimulation frequency and intensity based on feedback from the brain. Later, in 2021, the same scientists devised a way to record brain activity in people during daily life, providing constant feedback from the brain. Most recently, this team conducted a small clinical study with four individuals with Parkinson’s disease, comparing aDBS with conventional DBS. Results indicated that aDBS led to better motor control and improved quality of life compared to use of standard continuous DBS – mirroring the findings of the larger ADAPT-PD trial.
Ongoing BRAIN Initiative research aims to make even more improvements in aDBS. For example, researchers are exploring adaptive stimulation to restore sleep in people with Parkinson’s disease. Others have developed a unique pattern associated with a specific type of Parkinson’s tremor, leading to a more precise way to track real-time fluctuations of motor symptoms.
In another study funded by the National Institute of Neurological Disorders and Stroke (NINDS), which was facilitated by BRAIN Initiative-funded research, scientists are testing the use of a commercially available DBS system to place electrodes just under the scalp for long-term brain monitoring. Researchers will also apply artificial intelligence methods to analyze brain signals and automatically adjust settings. The goal of this research: 24-hour care in which aDBS can manage daytime movement symptoms and nighttime sleep improvement by continuously learning and adapting to an individual’s needs.
In summary, over the past 10 years, BRAIN Initiative research has been instrumental for developing and refining a technology solution for the millions of people worldwide living with Parkinson’s disease. The success of this foundational work is exemplified through the recent FDA approval of the aDBS technology.