... Perspectives from Those with Lived Experiences...

... Some patients benefit tremendously from implantable brain stimulation (McNasby, Nelson), while others experience little or no benefit. (Austin)...

... Not all candidates for implantable brain stimulation choose to have the procedure. The reasons vary but often depend upon a weighing of the risks and benefits. A ... who initially declines such a procedure may later choose to undergo it as their condition and the technology evolve. (Garrido-Revilla)...

... Some patients living with complex neurological or psychiatric conditions find that promising and even effective treatments are not covered by their insurance companies. This may prevent patients who could benefit from implantable brain ...

... illness is the lack of qualified practitioners in many parts of the country. Many patients end up moving to areas with first-class medical facilities and doctors in order to pursue deep brain stimulation treatment. (Garrido-Revilla, Nelson)...

... NOTE: This list is the rapporteurs’ summary of points made by the individual speakers identified, and the statements have not been endorsed or verified by the National Academies of Sciences, Engineering, and Medicine. They are not intended to reflect ...

... When considering optimal applications for deep brain stimulation (DBS) and its broader adoption, a constructive approach may be understanding the technology from the perspective of patients who contemplate and undergo it. During the workshop, four individuals living in the United States ...

... neurological disorders,” said Laura Lubbers, the chief scientific officer at CURE Epilepsy, “it is often thought of as a last treatment option and not a first- or second-line treatment. [The] panelists have differing neurological conditions which require unique neurostimulation solutions, but ... need from implantable brain simulation for it to be considered a successful treatment, discussed how adoption of the technology can affect patients and their quality of life, and finally, highlighted some of the biggest challenges to applying this technology from the patient perspective “in hopes ... finding solutions and pathways forward that might enable more people to adopt this as a treatment.”...

... A DISAPPOINTING EXPERIENCE WITH THE TREATMENT OF EPILEPSY...

... of directors of CURE Epilepsy, was diagnosed with epilepsy when he was 12. Now, at 49, he takes approximately 15 medications to control it. Although brain surgery can be used in some epilepsy patients to stop or reduce the number of seizures, he chose not to pursue that option because in his case the ... of half his body. “I would rather have seizures,” said Austin. Therefore, he decided on a procedure in which a device was implanted in his brain in an effort to use responsive neurostimulation (RNS) to control the seizures....

... unable to decrease the number of seizures. In fact, Austin said, the number increased, “which they absolutely did not expect.” The clinicians and research doctors had known it was a possibility that RNS would not work, he said, but they were optimistic, so “it was basically disappointing for ...

... best not to replace the device’s battery after 4 years, which is the typical replacement time. He thought that if the doctors could not figure out how to reduce his seizures with the device during that time,...

... they probably were never going to get it to work for him. So, the device remains in his brain, but it is not mitigating the epilepsy....

... unless you know what to look for. I do have them, on average, two times a day.” This means that sometimes he will go days without a seizure, and other days he will have multiple seizures. It prevents him from doing things like driving, and since one of the triggers for his seizures is body ...

...’s Research, described his experience with DBS used to treat his Parkinson’s disease. In 2019 he had been living with the disorder for 19 years, and he had reached the point where he was taking 20 to 27 pills a day to control it, but he was disappointed with the results. Thus, he chose to get DBS ...

... Instead of describing the results of DBS in words, he showed a video from the first time the device was turned on after implantation. At first, his hands were shaking noticeably, but as soon as the current began flowing through one side of his brain, the shaking in his right hand stopped. In the video ... says, “I feel like the problem which was always there is not there—like somebody turned my right arm back on.” His posture improves noticeably, and he reports to the doctor that he feels “speedy and less rigid.” After the device is turned on in both sides of his brain, he can be seen jogging ...

... McNasby actually had two devices implanted, one in each hemisphere, each with a battery and a lead into the relevant area of the brain. And each of the devices had a remote connection so that his doctor could adjust the settings remotely. This was particularly important, he said, in ... knew something had happened, but he was not sure exactly what. He called the doctor to tell her what had happened. Although she was not in her office and the Abbot representative was in a parking lot in Hackensack, New Jersey, and McNasby was in the Catskill Mountains in southeastern New York State, ... three of them were able to discuss what should be done. The Abbott representative was able to remotely turn the power on and off to the two devices and figure out what had happened. McNasby had to go back on his medication...

... McNasby noted that the implants have not been a panacea. While they have remedied his tremors and dystonia, he is now taking seven pills to help control Parkinson’s disease, and he has developed three categories of symptoms that he had never had, ... including REM sleep behavior disorder,1 a syndrome that is common among Parkinson’s patients, and balance issues, which have caused him to start festinating or sometimes needing to take smaller steps backwards in order to maintain an upright and ...

... Amid Nelson’s depression, his self-esteem and self-confidence got increasingly lower. In the beginning he was able to work effectively in his job in the corporate world, he said, likening himself ... alcoholic except that he was dealing with depression instead of alcoholism. On the surface he had everything, including three healthy children and an amazing wife, which made him question his behavior even more. “I didn’t understand what was going on,” he said....

... What happened, he continued, is that he began thinking about dying by suicide more and more until it became nearly constant. “I still drive around my town, and I know exactly which trees would be the best to slam my car into,” he ... . Over time he became less and less functional, to the point that his wife had to take on all his responsibilities, including going back to work to support the family. He watched ... her life crumbled and his own engagement with his children diminished. Although he had come to realize that he was suffering from a disease over which he had little ...

... REM sleep behavior disorder, sometimes called dream-enacting behavior, will “physically act out vivid, often unpleasant dreams with vocal sounds and sudden, often violent arm and leg movements.” For more information, see https://www.mayoclinic.org/diseases-conditions/rem-sleep-behavior-disorder/...

... “I started becoming extremely euphoric for death,” he said, and thinking about ways he might accidentally die. “I was obsessed with it. The reason I wanted that to happen is, if I died of an accident, it solved ... problems. My wife would get life insurance. My children would have a father who died of an accident, and I wouldn’t have to suffer anymore. So that consumed me—so much so that I would hear about a car wreck, hear about an airplane crash, and I was ...

... two residential treatment programs, more than 10 medications, three partial hospitalization programs (PHPs), two intensive outpatient programs, and even psychodrama therapy. Nothing worked. His depression was deemed treatment resistant....

... Fortunately, though, he was able to get into a clinical trial at the Icahn School of Medicine at Mount Sinai that was using DBS to treat depression. Although he had no expectations that the treatment would work, he said, he was not ...

... The Mount Sinai physicians and care team were amazing, Nelson said, and they took good care of him. The implant was inserted during an 8-hour procedure, and the device was turned on the next day. The effect was ... , with all the feelings of dread and the suicidal ideation vanishing. “I haven’t had a single suicidal thought since the surgery, August 22, 2022, and haven’t had a single feeling of depression,” he said. “It is a complete miracle.”...

... is new to this day,” he continued. “I want to go on vacation, to be present, walk my dog. I couldn’t do any of this stuff. To do that and go into an ocean and feel water on my body—just the most basic things you could ever imagine, I just feel extremely lucky to be here and extremely ... for the technology and scientific development that has happened.”...

... not to undergo DBS. Now a 58-year-old Parkinson’s disease patient, she was diagnosed at the age of 45 in May 2010, after enduring 3 years of tests and scans to determine what was affecting her. “No one could diagnose me,” she said. “I was a younger woman [and] Hispanic....

... At that point, she continued, she decided it would be a good idea to change clinics, and, indeed, when she went to a new clinic the doctors there quickly determined that she had Parkinson’s disease. That diagnosis felt “like a bucket ... ice water,” she remembered. “It was a shock for everyone.” A mother of two young, very active boys and a husband who traveled a lot, she wondered what she would do, how she would cope....

... Parkinson’s disease. At some point her doctor suggested that if the medications stopped working, she could try DBS. “I was excited,” she said, and willing to undergo DBS as an alternative treatment option that could help alleviate symptoms as the disease progressed....

... for DBS, she said, but various things caused her to question whether it was right for her. Because of her advocacy, she attended various conferences and support group meetings and spoke with people about their experiences with Parkinson’s disease and DBS. “I would ask their stories,” Garrido-...

... or experienced confusion. “I started thinking, ‘What if this is related to gender? Is there a clinical difference between Parkinson’s in women and men?’” She found a couple of studies from the National Institutes of Health that found that there is a gender gap in having DBS, with more men ... the procedure than women.3 That made her concerned that there might be differences in the standard of care between men and women. She also noted that as a Hispanic woman she was treated differently from White women in various ways, such as nurses assuming that she might ... speak fluent English and asking her if she needed a translator....

... Ultimately, Garrido-Revilla could not shake the feeling that as a Hispanic woman she might not receive the same standard of care as a White man and thus might not get as good a result. This affected how she viewed the risks and benefits of the procedure enough that she has decided, for the moment ... has not ruled out the possibility that she might do it sometime in the future. She knows that many people have been very happy with the results, and she may still decide to move forward....

... Unexpected Experiences...

... Lubbers asked the panelists each to talk about what was unexpected, in either a positive or negative way, in their experiences that they would want people to know about....

... of precision after the implantation for Parkinson’s disease. There was so much rigor before the surgical procedure (e.g., multilayered brain scans and robotics to ensure the exact placement of the leads) that McNasby was surprised by the trial- and-error approach to adjust the electrical stimulation....

... Nelson did not expect the DBS device to work as quickly as it did for his depression. But then once the implant was on and working well, he worried about what would happen if it stopped. In the clinical trial he participated in, the device was scheduled to be turned off ... a week 6 months after the initial surgery. “I was so scared,” he said, and he spent much of that 6-month period talking to the team about how he would handle it. He was heartened when one of the doctors on the team, a ...

... scalp—he did not realize they would be so prominent. While he does sometimes feel self-conscious about the implants, they represent his journey, and that is something Nelson is proud of....

... him, he said, because “nothing has really ever worked,” but he did not expect the increase in seizures. Second, he did not expect how much trial and error the process would involve on the doctors’ part. “It is not as if they knew exactly what they were doing,” he said. “They were actually ...

... Clinical Management and Standard of Care...

... Given the different experiences among patients with their clinical care teams, Lubbers asked: “What does the gold standard look like? What do medical teams need to know to help improve patient care?”...

... The current standard of care leaves much to be desired for patients with severe mental illness, Nelson said. Most of the treatments he tried were not covered by ... and had to be paid for out-of-pocket. It was extremely frustrating to get a letter from his insurance company refusing to pay for a treatment because it ... by the Mount Sinai team. “I felt like a VIP,” he said. “It was the most incredible patient experience you could have.” Both his preoperative and postoperative care were incredible and served as examples of how mental illness should be managed. “I’m so grateful for the kindness and empathy ...

... received DBS for her Parkinson’s disease, echoed Nelson’s points on the difficulties with insurance coverage. The insurance supplied by her husband’s employers did not cover several medications, and these added up to thousands of dollars a month. So she worried about the costs of getting an ... for DBS, and that is one of the factors she considers in thinking about whether to get the procedure....

... in his insurance coverage because as the former general counsel of one of the country’s largest insurance brokers, he knew a lot about insurance and had advocates in the business helping him personally....

... it would not cover the procedure because it was not proven. “Fortunately for me, the neurosurgeon called his counterpart at the insurance company, and it got covered,” he said. However, if an insurance company denies coverage to an individual, the individual may not have the same privilege or ...

... in different regions of the country, Garrido-Revilla said that many parts of the country need more neurologists, more movement disorder specialists, and neurosurgeons with experience in DBS. “The system is lacking the personnel to cover the needs of the patients,” she said. “I used to live in ...

... Nelson agreed and said that many patients relocate so that they can be close to doctors and clinics that know how to care for their conditions....