Starting today, people with Parkinson's disease will have a new treatment option, thanks to U.S. Food and Drug Administration approval of groundbreaking new technology.
The therapy, known as adaptive deep brain stimulation, or aDBS, uses an implanted device that continuously monitors the brain for signs that Parkinson's symptoms are developing. When it detects specific patterns of brain activity, it delivers precisely calibrated electric pulses to keep symptoms at bay.
The FDA approval covers two treatment algorithms that run on a device made by Medtronic, a medical device company. Both work by monitoring the same part of the brain, called the subthalamic nucleus. But they respond in different ways.
A "fast" algorithm detects patterns associated with symptoms and immediately suppresses them. A "slow" algorithm provides stimulation that maintains the person's brain activity within a range where symptoms are reduced.
The fast approach was developed by UC San Francisco neurologist Simon Little, MBBS, PhD, in 2013, while he was a Wellcome Trust clinical research fellow at Oxford University with Peter Brown, MBBS.
aDBS is a significant advancement over a treatment called continuous DBS, or cDBS, which delivers constant stimulation to the brain. cDBS has been used to improve Parkinson's symptoms since it was approved by the FDA in 1999.
aDBS, unlike cDBS, can sense and adjust when a patient's brain activity changes, which often happens when people with Parkinson's take their medications. aDBS's constant monitoring also enables it to smooth out the peaks and valleys of brain activity, fending off symptoms like stiffness and involuntary movements before they arise.
Patients and their health care providers will be able to choose which adaptive algorithm to use and be able to easily switch from one to the other using software that communicates with the device via Bluetooth.
As the algorithms are more widely used, clinicians will get more insight into how different patients experience them. They may be able to prescribe one or the other based on their knowledge of the patient.
The early adaptive DBS algorithms approved today are just the first step in what's possible."
Simon Little, MBBS, PhD, UC San Francisco neurologist
Soon, round-the-clock Parkinson's care
Since coming to UCSF in 2019, Little has continued to developed and test even newer aDBS algorithms for treating motor symptoms like stiffness and tremors as well as non-motor symptoms like mood dysfunction and insomnia that people with Parkinson's experience.
In a study published last August, Little and neurosurgeon Philip Starr, MD, PhD, designed an algorithm that monitors and responds to brain signals in the cerebral cortex. This is a different brain region than was targeted by the two algorithms approved by the FDA. The new algorithm and location improved symptoms and reduced side effects better than cDBS.
The UCSF effort was the first "double-blind" trial of aDBS. That means participants went about their lives at home while the algorithms were changed, and neither they nor the researchers knew what settings were in place at a given time.
The UCSF team's algorithm is more complex than those approved by the FDA on Monday. The researchers are still developing the approach, but it has improved quality of life for participants in a small clinical trial, even allowing a former pro skateboarder to return to his sport.
Little anticipates that in the future, artificial intelligence will make it easier to customize the algorithms. Future technology will also address other Parkinson's symptoms, like depression and sleep dysfunction.
"We'll be able to give people with Parkinson's round-the-clock personalized DBS therapy," he said.
Researchers at UCSF are exploring how to use personalized DBS for depression, chronic pain and obsessive-compulsive disorder. Today's approval gives momentum to the development of DBS to treat those conditions as well.
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