... Many patients who could benefit from deep brain stimulation must fight stigma and a system that is not always set up to direct them to the proper providers. (Ellis)...

... Socioeconomic and demographic disparities in the use of implantable brain stimulation will need to be addressed if the technology is to become fully adopted into the ...

... It will be vital to educate the various stakeholders, including not only patients but also clinicians, researchers, and engineers, to have a more accurate and complete understanding of the technology and the barriers it faces. (Hammer)...

... How an innovation gets through the regulatory system is vital to its success, and innovators should be working with regulators from early in the innovation cycle to smooth the new technology’s path to market. (Kelly, Lisanby)...

... Reimbursement issues should be handled in parallel with regulatory issues. (Kelly, Lisanby)...

... There is a need for more objective outcome measures, such as with biomarkers, in both the research and the regulatory arena. (Lisanby)...

... Through collaboration, innovation, and optimism, the system can be changed. (Mahoney)...

... 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 ...

... Mayberg and Denison asked participants to reflect on the core themes and takeaways from the workshop and explore creative approaches or collaborations needed to move the field forwards toward the adoption of implantable brain stimulation into the ... of care across central nervous system disorders. Workshop participants also discussed the implications of comorbidities and opportunities to develop technologies and treatments to holistically treat patients....

... Brandy Ellis, a neuromodulation patient advocate who has a deep brain stimulation (DBS) implant, shared her journey to treatment and perspectives on what’s needed to move the field forward. Before she received the implant as part of a clinical trial, she said, she had had 4 years ... tried 25 different medications, not including different dosages, different combinations.” She had also had 24 electroconvulsive therapy treatments, and she had been dropped as a patient by a half dozen psychiatrists....

... “For me in the trial it was very much not flipping a switch,” she said, unlike the experience that Jon Nelson had described in Chapter 4. “I became a responder, which meant my depression rating scale had been reduced by 50 percent at 6 ...

... “I will say that the one side effect I did not expect was a nearly pathological desire to talk to anybody about patient advocacy, mental health, and DBS,” Ellis said. “I am now a fully functioning, healthy, happy, mood-appropriate, functional adult who supports herself and has good ... , and has a full-time job. This is my bonus life, and I went from absolutely terminal treatment-resistant depression to this life that I have now.”...

... University, offered a few thoughts about increasing the use of DBS. First, he said, it will be important to address the presence of socioeconomic and demographic disparities in the use of invasive neurologic systems. “I don’t think there is a path toward broad adoption if we don’t wrestle ...

...-Revilla’s remarks (Chapter 3), he said that her observations about sex differences in DBS treatment are true. “That is something we understand is an issue, where women are maybe 20 percent or 30 percent less likely to receive DBS after they have been screened as good candidates,” he said. � ... ��And as a Black American, I’m much less likely to be a DBS recipient.” Geographical disparities also exist, with people from rural areas much less ... to receive these treatments than those living in major urban areas, particularly those with major medical centers such as Cleveland or Boston or Houston. “Grappling with [these] topics is something we have to take seriously,” he said....

... Doug Kelly, deputy director of the Center for Devices and Radiological Health of the U.S. Food and Drug Administration (FDA), began by describing his background, which included being a venture capitalist in Silicon Valley, starting several ... himself, and working as a physician and in a laboratory....

... workshop that struck him, he said, is how much it paralleled his own experience. “I know from a lot of therapy that I’m primarily driven by fear and anger,” he said. “When I hear Jon [Nelson]’s story, it makes me angry that he has to fight for his own care. It’s dehumanizing to do that. ... drives a lot of my motivation to change a lot of things at the Food and Drug Administration.”...

..., or TAP. The idea behind it, he said, is to bring together different sectors from the beginning to provide early opportunities to collect input and feedback. He based the TAP program on lessons he had learned starting his own companies, he said, particularly the importance of answering...

... significant questions about a product and how it will make a profit early in the development process. He described TAP as “a consultancy inside the FDA” that helps innovators maximize ... chances of bringing a useful and valuable product to market. For instance, he said, “Often the fastest way through the FDA may not be the best to get you the evidence you need. The ... strategic advantage, your biggest competitive advantage. It may take a little more time to generate that, but you will suffer so much less failure and so much less time in unprofitability. You can’t have a product that makes it out to patients unless it is profitable, and people make money doing ... .” The goal of TAP, he said, is to “figure out those things up front and figure out the most efficient path forward.”...

... When reflecting on the workshop discussions, Sarah Hollingsworth Lisanby, the director of the Noninvasive Neuromodulation Unit and the Division of Translational Research at the National Institutes of Mental Health, organized the themes into the four R’s: research, regulation, ... , and real world. “When we think about the idealized pathway,” she explained, “you start with research, [then] get regulatory approval, reimbursement ... , and achieve real-world impact.” But the various opportunities and gaps discussed at the workshop complicate that simple picture, she said. “We need to redraw arrows. They are not just linear. Some have feedback ...

... important things she had heard at the workshop relating to each of the four R’s. In the research arena, she said there is a need for better targets and objective outcome measures, perhaps with biomarkers (Alagapan et al., 2023; Deng et al., 2020). Concerning regulation, she emphasized how the FDA has ... accelerate the development of new technologies. “At the level of reimbursement,” she continued, “we have learned that it really should be done and thought about in parallel with regulatory approval,” noting that there are programs for parallel review at FDA and the Centers for Medicare & ...

... And at the level of real-world impact, she said, “I thought of the three Cs: clinicians, communities, and care disparities.” Clinicians need training and support, biomarkers that are scalable and reliable for guiding their decisions, and ... collaboration. Concerning communities, she continued, “we have heard about lived experience and how that should really be centered in all of our thinking in this regard.” It is also...

... important to think about whether a device meets the needs of a community and as was seen in the example of the Deaf community’s response to cochlear implants, whether it is culturally sensitive. Concerning care disparities, ... said, “we learned there are disparities in access, diagnosis, and treatment along lines of gender, race, and ethnicity.” Mental health or other health conditions can also impact a patient’s access to treatment, she said. “When we think about how that ...

... Hammer named three things she had identified as important during the workshop. The first was a “focus on broad education and communication among all the stakeholders here.” Certainly, the public needs to have a better understanding of what brain stimulation is and to ... ” but something that has been around for decades, she said. In particular, patients need better education so that they can advocate for themselves and recognize when a procedure might be appropriate. Clinicians need to be better educated about how to integrate this technology into their own practice,...

... considerations. Overcoming the financial hurdles facing the technologies will require various approaches, including creating various incentives and making the devices more efficient, noted Hammer....

... be optimistic (Chapter 5). “We created this system, we can fix this system,” he said. “But it means we all have to . . . look across the aisle and not just maximize our position but [that of] all the stakeholders involved.”...

... used to the way things are,” he continued. “I think if we change—we, the health system at large—I think we can bring more advances quicker and faster to the globe.”...

... he participated in the workshop—because communication and putting the patient first are important. “One of the first things they teach in medical school,” he said, “is if you do tests and at the end of the day still don’t know what is wrong with the patient, ask. They will almost always tell you....

... Ellis responded to a question about what can be done to support giving a voice to patients and their groups. Patients absolutely can provide information about health care–related issues that is important to hear, she said. “There are some ...

... Ellis also said that she found very few support options. People in her situation tend to get referred to the National Alliance on Mental Illness2...

... 1 MAOIs are a class of effective and well-studied drugs that include the first antidepressants developed. They work by inhibiting the action of monoamine oxidases, enzymes that remove ... , serotonin, and norepinephrine from the brain; thus, MAOIs act to increase the levels of dopamine, serotonin, and norepinephrine in the brain....

... or the Depression and Bipolar Support Alliance,3 she said, but those organizations “don’t have resources for the atypical people.” They also cannot provide a list of ...

... over $75,000 for me to be admitted in case my insurance didn’t cover my inpatient stay.” Furthermore, her parents paid for her to move to Atlanta and supported her while she was out of work because clinical trial participants are not compensated. “So how do you get people who can’t work because ... that we’ll be on disability is not accurate. The ability to get disability is a nightmare.” While acknowledging that she got incredible care and that she is “so thankful for this bonus life that I have,” Ellis noted that she had to agree to be experimented on and be awake during brain ...

...,” he said. “Part of it is the way a lot of patient advocacy groups are founded. There’s some on one end of the spectrum that are hypercompetent and really good at getting message out, in Parkinson’s disease and diseases like that. There are others where the voice is much weaker. Part of the ... with TAP program as well is make sure we help those patient advocacy groups become better at having a big impact on what technologies get developed and how they develop.”...

... researchers can learn from people who take part in clinical trials. “I see patients as collaborators,” she said. “I’m doing something to you, and you are giving something to me.” She also said that every patient in a clinical trial should get rehab to learn how to live with the implant. “ ... gets a heart pacemaker and doesn’t get cardiac rehab,” she said. “Nobody gets their knee replaced or hip replaced or gets an insulin pump and doesn’t learn how to control their diet, learn how to exercise, get a physical therapist.” The same is true for implantable brain stimulation....

... 3 For more information on the Depression and Bipolar Support Alliance, see https://www.dbsalliance.org (accessed January 18, 2024)....

... A workshop participant asked what each panelist is planning to do as a result of participating in this workshop and how the workshop changed their perspective on what the field needs to do going forward....

... Lisanby answered first and spoke about the need for objective biomarkers. In psychiatry, she said, when researchers doing clinical trials rely exclusively on subjective symptom- ... diagnosis and outcome measures, it often leads to a significant amount of heterogeneity within diagnoses and comorbidity across diagnoses and fails to map well onto brain circuitry. Objective biomarkers can be used to reduce that heterogeneity and inform treatment decisions. She mentioned a ...

... Kelly answered next and spoke about speeding up the approval process at the FDA and other regulators. “There’s lots of functions that happen serially that dramatically increase the time to get patient access to devices,” he ... some of those things into FDA studies early on, . . . it is our responsibility to do that. Our public mission at FDA is timely patient access to safe and effective medical devices. We really need to redouble our efforts on that timely patient access. It is not okay when you have a process that takes 20 ... , he said, is how to reduce those 20 years to ideally under 10 years, making the process similar in length to what venture capitalists are used to and thus making it more attractive to invest in this area. “Today really makes me want to redouble my effort and really dig into those relationships,”...

... Hammer said that hearing some of the patients’ stories made her want to find ways to ease their burden. “I’m just starting my career and seeing patients, trying to build a research program,” she said. “I have always thought of community education as something that I will get to ... .” Now, she continued, hearing about the importance of first-line providers such as general neurologists and psychiatrists being knowledgeable about these technologies, “I personally will probably change in terms of what I view as a priority.”...

... Pulliam said that the workshop discussions convinced him that the adoption of implantable brain stimulation or any other new intervention into the standard of care is not just about the research, but it is also influenced by factors beyond research, such as the health care system and the payer system. ...

... all of you to continue to do the work you are doing because this is absolutely meaningful treatment that absolutely is critical for people to survive and enjoy life.”...

... Mahoney closed out the discussion period. “I’m inspired by opportunities and want to keep pushing forward,” he said. “I will do a better job with my colleagues across the country pushing them toward total value of care and ...

..., Mayberg said, “My takeaway bullet point is angry but optimistic.” “Anger is a representation of impatience with things that are obvious and that you have the data, and nobody is listening. That is what makes people angry.” However, she said, seeing the individuals with lived and living ...

... A second takeaway, she said, is the importance of getting all the clinicians, researchers, and engineers working together—psychologists, neurologists, physiologists, engineers, and so forth. “I’m inspired by Kevin [Mahoney] that there is ...

... Denison then offered his own takeaway. “The analogy floating around in my head for the day is, we have a jazz band where we have all the members of the band on the stage, but we are not yet playing the tune together. That requires us to do a lot more listening. ... a good jazz band, you are listening and building and going with the flow with your companions and accentuating but also giving up the stage as well and giving that notion of a band as being an ecosystem and being mindful. That is my takeaway, making sure I’m listening and not trying to have my ...

... Denison closed the workshop by acknowledging the patients who make his work and that of other researchers and clinicians possible. “The real...