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Perspectives from Those with Lived Experiences
HIGHLIGHTS
- 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 patient 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 stimulation from receiving it. (Austin, Nelson)
- One obstacle to more people getting implantable brain stimulation to treat mental 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 a consensus among workshop participants.
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 with medical conditions that can be treated with implantable brain stimulation shared their perspectives. Their experiences ranged from having almost complete success in treating the condition to seeing very little improvement to deciding not to have a device implanted at all.
“Despite the success of neurostimulation in treating 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 perhaps by looking across them we may find commonalities that may help advance all of them.” Workshop participants explored what patients 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 of finding solutions and pathways forward that might enable more people to adopt this as a treatment.”
A DISAPPOINTING EXPERIENCE WITH THE TREATMENT OF EPILEPSY
Steve Austin, a member of the board 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 surgery would require removing tissue from the motor cortex, which could result in paralysis 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.
Unfortunately, after 4 years of doctors experimenting with various settings on the device, they were 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 everyone.”
Given that situation, Austin decided in collaboration with his clinician that it was probably 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.
Instead, Austin uses medication to help control the seizures. “What I have now manages the epilepsy well enough,” he said. “You won’t notice I’m having a seizure 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 heat, he cannot do much physical exercise. “So, there are certain downsides that I have learned to live with over time,” he said. Knowing that as he gets older the disease may lead to further complications, he had hoped that the brain implant would make a difference, but ultimately it did not.
SUCCESSFUL TREATMENT OF PARKINSON’S DISEASE
Jim McNasby, general counsel of the Michael J. Fox Foundation for Parkinson’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 to alleviate his symptoms.
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 he 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 down the hall, taking great pleasure in an ability he had not had for many years.
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 September 2022, when a wire on the left side broke. He 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, the 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
until he could have the surgery to replace the wire, but otherwise everything turned out fine.
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 balanced position.2 Still, in spite of these new symptoms, McNasby views the procedures as a success.
LIFE-CHANGING RESULTS IN TREATING DEPRESSION
Jon Nelson was diagnosed with major depressive disorder (MDD) in 2012. Nelson, who is with Jon Nelson Advisors, LLC, began with a gripping description of the effects that major depression had on him.
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 to a high-functioning 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 said. 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 as 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 control, he could not help but feel that everyone would be better off without him.
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1 A person with 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/symptoms-causes/syc-20352920 (accessed November 26, 2023).
2 Festinating or festinating gait is characterized by short, shuffled steps to prevent falling due to an individual’s center of gravity being too far forward, sometimes caused by a stooped position. For more information, see https://parkinsonsdisease.net/symptoms/parkinsons-gait (accessed February 27, 2024).
“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 my 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 jealous that it wasn’t me. That is what it is like to live with this disease.” At that point he counted a day as successful if he was able to take a shower, or if he slept for 12 hours plus a nap instead of sleeping for 16 hours.
He tried everything he could think of to survive, he said, including 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 concerned about any possible negative outcomes. Because nothing had worked to that point, he saw his two options for the future as being living in misery or dying by suicide, which made him willing to try what seemed to be a long shot.
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 instantaneous, 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.”
“Everything 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 lucky for the technology and scientific development that has happened.”
CHOOSING TO FORGO AN IMPLANT
Claudia Garrido-Revilla, a member of the patient council at the Michael J. Fox Foundation for Parkinson’s Research, shared her perspective of choosing 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 some point I asked, ‘Could it be Parkinson’s? Do you think it could be Parkinson’s?’” But the doctors would say, “‘Oh no, no. Your characteristics don’t qualify you. We are sure it is not Parkinson’s.’”
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 of 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.
Under the guidance of her doctor, Garrido-Revilla began taking the basic medications used to treat 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.
Initially Garrido-Revilla was very positive about getting an implant 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-Revilla said. “They would tell me everything.” She found that the men she spoke with generally had very positive experiences with that treatment, feeling as though it made a major difference in their symptoms.
But the women, Garrido-Revilla observed, did not seem to have such positive experiences with DBS. Some of them had certain speech issues 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 having 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 not 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 at least, not to proceed with it. However, Garrido-Revilla 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.
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3 See, for example, Sarica et al. (2023).
DISCUSSION
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.
McNasby said that he was surprised by the lack 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 for 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 psychiatrist, told him that if he felt anything, it probably would not be until about 5 days after the device was turned off. That is exactly what happened. While he did not experience any mental symptoms, the disease physically took over his whole body. He made it through that week, but it took him another 3 weeks to get back to baseline after the device was turned back on. Currently, he added, he now has an investigational device, which must be charged every 2–3 days. “I pretty much am worried at all times it is not working,” he said, “so I have massive anxiety about that.”
Nelson shared that he was also surprised by the size of the implants under his 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.
Austin spoke about two things that surprised him after receiving RNS as a treatment for his epilepsy. First, he was surprised that the frequency of his seizures increased after the procedure. He was not really surprised that RNS did not work for 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 learning as they went along.” This did not feel really ideal to him, he added, but he hopes that at least the doctors learned something that might be able to help other people.
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 insurance 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 was “not medically necessary” when that treatment might help him not die by suicide, said Nelson. By contrast, he was treated exceptionally well 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 of the entire clinical team,” he said.
Garrido-Revilla, who has not yet 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 implant for DBS, and that is one of the factors she considers in thinking about whether to get the procedure.
By contrast, McNasby said he was very fortunate 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.
Austin said that he was able to get his procedure covered by insurance, although that coverage was not automatic. Initially his insurance company said 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 resources to convince the insurance company to provide them with coverage or reimbursement.
Access to Care
In response to a question from Lubbers about access-to-care challenges 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 central Illinois. The [single] provider was definitely not enough. I had to
go to Chicago to get my care.” Although she has since moved to Houston to increase her access to care, she said that “the medical system is not prepared for the amount of Parkinson’s disease patients out there,” including potential DBS patients.”
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.
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