At 69, Hoyt 鈥淐orky鈥 Ball knew something was wrong when his right hand began to tremble uncontrollably. His primary doctor ruled out Parkinson鈥檚, but the prescribed medication failed to alleviate his symptoms. It wasn鈥檛 until Ball met neurologist with the and associate professor in the that he received a definitive diagnosis.
鈥淚n about 10 minutes, he knew I had Parkinson鈥檚,鈥 Ball said.
Guduru suggested a treatment called deep brain stimulation (DBS). DBS is described as a 鈥減acemaker for the brain.鈥 By placing electrodes within malfunctioning brain pathways, DBS disrupts abnormal signals that causes tremors and other symptoms.
As Ball began researching his diagnosis and suggested treatment, he came across 好色先生 HealthCare鈥檚 and his work on a procedure known as DBS-Plus. Van Horne, who is a neurosurgeon, is co-director of the 好色先生 HealthCare Neurorestoration Center (NRC) and a team of physician-scientists and researchers leading a first-of-its-kind clinical study aimed at stopping or reversing the degenerative effects of the Parkinson鈥檚 disease.
The study combines DBS with an experimental nerve-grafting procedure. The nerve cells are transplanted during DBS surgery, meaning patients do not have to undergo additional procedures.
In this combined approach, now known as DBS-Plus, the surgeon transplants peripheral nerve tissue into an area of the brain where neurons are dying. The grafted cells are being tested for their ability to release chemicals believed to rejuvenate the brain鈥檚 weary dopamine-producing neurons. Van Horne and his team take a small piece of nerve tissue from the patient鈥檚 ankle and implant it in their brain. Because the tissue is from the patient鈥檚 own body, there are no concerns about rejection. Because the experimental treatment is applied during a procedure that was declared safe and effective by U.S. Food and Drug Administration decades ago, DBS-Plus is considered relatively safe with only minimal additional risk.
Since the 1800s, scientists have known that peripheral nerves, which exist outside the brain and spinal cord, possess regenerative qualities that central nervous system nerves do not. The 好色先生 team hopes to leverage those regenerative effects within the brain, potentially halting or reversing nerve damage caused by Parkinson鈥檚.
鈥淲hile the peripheral nervous system can repair itself, the central nervous system does not do a very good job of it,鈥 said van Horne, the study鈥檚 principal investigator. 鈥淪o, the question is can we tap into the ability of the peripheral nervous system鈥檚 response for repair. Can we bring that to the central nervous system?鈥
To test the effect of the graft, researchers can simply turn off the DBS pulse generator and evaluate patient鈥檚 symptoms at a baseline level. The team鈥檚 vision is to alter the course of Parkinson鈥檚.
鈥淥ur concept for DBS-Plus, the 鈥榩lus鈥 part being the nerve grafting, is disease modification,鈥 van Horne said. 鈥淧reviously, all of the other transplant models were looking at symptoms and not disease progression and from that standpoint, that鈥檚 where we can say the DBS-Plus has its big advantage.鈥
Parkinson鈥檚 disease is a progressive disease. Once it starts, there are currently no treatments that will prevent it from worsening.
鈥淵ou can give medications, you can even do deep brain stimulation, and you can treat some of the symptoms, but you don鈥檛 stop the progression. That鈥檚 what we are trying to fix,鈥 said van Horne. 鈥淲hat we really want to determine is, 鈥榃hat is it going to take to get patients to a better place?鈥 It is not going to be just one thing and one-size-fits-all.鈥
Intrigued by the potential of DBS-Plus to not only help him but also advance medical understanding, Ball decided to participate. 鈥淚 really didn鈥檛 want to have DBS without doing DBS-Plus. It might not help me, but it may help somebody later,鈥 he said.
Ball鈥檚 journey with DBS-Plus began in February 2023, and he has since experienced remarkable improvements. Before DBS-Plus, his tremor made daily tasks nearly impossible. 鈥淭alking to somebody, my hand just went crazy. I couldn鈥檛 do anything with my right hand,鈥 he remembers. It was a tough reality for someone who was often on ladders and rooftops working in construction.
Today, Ball reports being 90% better.
鈥淚 don鈥檛 think I will ever be 100%, but my life has improved greatly. My overall health is better. You can鈥檛 tell I ever had Parkinson鈥檚," he said with a smile. Ball says his medication has reduced from 12 pills a day to just three. 鈥淚鈥檝e been able to continue my work as a school bus driver in Nelson County, a job I have done and love for eight years now. I also can play the guitar again which is also something I love to do.鈥
Van Horne hopes that DBS-Plus will eventually become the new 鈥渟tandard of care鈥 for advanced Parkinson鈥檚. This summer the work took a big step towards that, receiving its first ever support from the National Institutes of Health (NIH). 鈥淭his has really legitimized to some degree of what we have been working to do,鈥 said van Horne.
鈥淭o get NIH funding, it has to go through many committees of researchers and clinicians who review the work, they compare it to other people鈥檚 work and if you鈥檙e successful and they think it鈥檚 worthwhile, then they鈥檒l say that it鈥檚 worth funding.鈥
The study is known as the STAR trial. Greg Gerhardt, PhD, John Slevin, MD, and George Quintero, PhD, are leading the work along with van Horne. It spans the departments of neurosurgery, neuroscience and neurology within the 好色先生 College of Medicine.
This NIH grant will provide the opportunity to carry out the first double-blinded study of this approach. A double-blinded study is a type of clinical trial in which neither the participants nor the researcher knows which treatment or intervention participants are receiving until the trial is over. The approach is keenly important in developing a possible future efficacy trial to fully assess the use of peripheral nerve repair cells. Until now, researchers have primarily focused on altering the progression of the motor symptoms of Parkinson鈥檚 disease. With this grant, they can now begin to evaluate a strategy to alter the progression of nonmotor symptoms of Parkinson鈥檚, in particular cognitive disorders which may overlap with neurodegenerative diseases.
Up until this point, the work has been sustained by philanthropy and community support, which van Horne and the rest of the team are immensely grateful for. It鈥檚 an approach that doesn鈥檛 generate money, since doctors are using the patient鈥檚 own nerve cells.
鈥淭he concept of these trials and the work that we鈥檝e done, have all been generated by us,鈥 said van Horne. 鈥淭his is not part of a company. We鈥檙e not trying to form a company. We鈥檙e not trying to develop a product that we鈥檙e going to take to market and sell. We are really trying to just solve this problem. The NIH is really good about funding the basic science, but when it comes to translating and furthering the work to show it is really effective鈥ho is going to help pay for that research? That usually falls on the shoulders of drug or device companies.鈥
That is a big reason why the team is extremely proud to receive this NIH grant.
鈥淔or us to get something like this is remarkable. We don鈥檛 have corporate support. We don鈥檛 have company support. We don鈥檛 have a good business model. We just want to be able to translate this into better outcomes for patients,鈥 said van Horne.
Ball鈥檚 experience with DBS-Plus is a beacon of hope for many battling Parkinson鈥檚 disease. His journey underscores the importance of innovative treatments and the relentless pursuit of better outcomes for patients.
鈥淚 have absolutely no trouble. My quality of life is better than I could have ever hoped,鈥 said Ball. 鈥淚鈥檓 doing things I love and celebrating the big milestone of my 50th wedding anniversary this year.鈥
Now as van Horne and the rest of the team continue their groundbreaking work with renewed energy generated from NIH support, stories like Ball鈥檚 emphasize the potential to change lives.
鈥淲hen we turn off the stimulators, we see patients who are improved,鈥 said van Horne. 鈥淪o, I think there鈥檚 a lot of hope, and now is the chance for us to be able to prove that.鈥