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The University of Florida-based clinical trial, supported by the National Institute of Nursing Research of the National Institutes of Health, demonstrates a proof of concept that could help make DBS therapy more accessible to people who are unable to travel to academic health centers or large cities where the treatment is typically available. Findings from the open-label, randomized clinical trial, a collaboration between University of Florida Health, the University of Utah, the Medical College of Wisconsin and the University of North Carolina-Wilmington, appear in the latest edition of JAMA Neurology.
From 2017 to 2020, the research team evaluated 44 participants with Parkinson’s disease who were randomly assigned to two groups: those managed at home by a home health nurse who had no prior DBS experience and used an iPad app to select DBS settings for each individual patient, and those who went to the clinic to receive postoperative programming. The researchers reported no study-related adverse events and no significant difference between the two groups in how well DBS worked to alleviate symptoms, including tremor, stiffness and balance problems.
The results open the door to a new care model for people with Parkinson’s who receive DBS surgery, said co-principal investigator Christopher Butson, Ph.D., a biomedical engineer formerly of the University of Utah who recently joined the UF faculty to direct a new neurotechnology laboratory at the Norman Fixel Institute for Neurological Diseases at UF Health.
“Coincidentally, the clinical trial ended just as COVID was taking off,” Butson said. “The pandemic led to an unprecedented expansion of telemedicine, further highlighting the need for new approaches to patient care like the model tested in this study.”
For certain patients with Parkinson’s disease, DBS is an established treatment that involves surgery to implant thin electrical wires into specific brain areas and then connect the wires to a pacemaker-like generator implanted under the skin of the upper chest to deliver beneficial stimulation to malfunctioning brain circuitry.
“Many of these advanced, complex therapies are offered primarily at academic hospitals or in big cities,” Butson said. “For people who live close by, that’s OK, but in the U.S., we have vast rural areas where managing therapy this way could be a substantial burden on the patient and the caregiver. We wanted to see if we could eliminate that burden.”
To do that, Butson and his team created an “expert system” used on an iPad that provides visual guidance on how to program DBS devices. Unlike a prescription for a medication, DBS doesn’t have a common “dose;” rather, the stimulation settings are adjusted for each individual to provide the best therapeutic benefit possible with minimal side effects.
The team intentionally chose a home health nurse who did not have prior experience with DBS and trained her to use the system. The nurse had an interactive digital model of the patient’s brain, and as she changed settings, she could see the response on the screen.
“It allows the nurse to choose settings that steer the DBS to the areas of the brain that are most likely to provide therapeutic benefit,” Butson said.
The people with Parkinson’s who received postoperative programming in clinic saw a physician or nurse who adjusted the DBS settings and then observed the patient and used testing to optimize treatment.
Over a six-month study period, the research team evaluated both care models for safety and efficacy. The at-home Parkinson’s group received both in-person visits and phone calls from the home health nurse, and they were told they could call the nurse or physicians at any point.
“We found that this new DBS care model is feasible, safe and effective,” said co-principal investigator Michael S. Okun, M.D., chair of neurology at UF and executive director of the Fixel Institute. “The nurses performed just as well as experts in the field. This will change the paradigm for device delivery and should make DBS more accessible to all.”
The next step in this line of research will be a follow-up clinical trial to evaluate nurse-managed DBS settings through telemedicine, rather than in-person home visits, Okun said. The trial will also test novel wearable devices to remotely measure tremor, dyskinesia and motor fluctuations, all potentially disabling symptoms of Parkinson’s disease.
