Non-Invasive Neuromodulation of the Central Nervous System Opportunities and Challenges: Workshop Summary (2015) / Chapter Skim
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2 Overview of Gaps, Challenges, and Potential Opportunities
2 Overview of Gaps, Challenges, and Potential Opportunities
Pages 5-20
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From page 5... ...
Indeed, Jeffrey Nye suggested that these devices could essentially disrupt the regulatory approval of medical devices by further blurring the distinction between medical and non-medical approaches. They could also disrupt clinical trials by making it increasingly difficult to identify treatment 5
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In addition, policy issues were examined, and workshop participants focused their discussions primarily on challenges and potential opportunities related to ethical, legal and social implications, regulation, reimbursement, and the current business development environment for non-invasive neuromodulation, all of which are further discussed in subsequent chapters. While there are a number of barriers to address, including the need for a greater understanding of the underlying mechanisms and longterm effects of neuromodulatory devices, many participants acknowledged the vast opportunities of such devices and how all sectors (e.g., regulatory, payers, researchers, companies, and society)
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The Large Number of Parameters Involved in Non-Invasive Neuromodulation: Challenges for Understanding the Neurobiological Effects • The efficacy of non-invasive neuromodulation is highly variable, most likely because of both individual differences, patient differences, differences in stimulation characteristics of the various devices, and failure to engage the appropriate neurobiological target (differences in the brain substrates of similar symptoms and disabilities) (Pascual-Leone)
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. Knowledge Gaps Regarding Appropriate Control Conditions and Clinical Trial Designs • Better design of sham stimulation and control conditions are critical to assess the effects of non-invasive neuromodulation in clinical trials (Hallett, Pascual-Leone, and others)
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. • Research is needed to better understand the impact of non invasive brain stimulation on distributed brain networks -- the effects of brain stimulation does not remain limited to the directly targeted brain area and, in fact, the behavioral and ultimately therapeutic effects may be mediated by impact on distant brain regions reached via trans-synaptic network effects.
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. • Various types of modeling, including realistic head modeling of the induced electric field distribution in the brain, and animal models of the physiological responses to stimulation provide opportunities for better understanding the effects of different types of non-invasive neuromodulation (Lisanby)
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. BOX 2-1 Variables Associated with Non-Invasive Neuromodulation The box lists the various uses, settings, technologies, parameters, and conditions for which non-invasive neuromodulation has been indicated or researched, as mentioned by individual workshop participants.
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Because this is a summary of workshop comments and is not intended to reflect consensus, this table and its content should not be attributed to the rapporteurs of this summary as informed by the workshop. Optimizing the Therapeutic and Non-Therapeutic Uses of Non-Invasive Neuromodulation Through an Improved Understanding of Clinical Effects, Safety, and Efficacy • The field of non-invasive neuromodulation, and stimulation in combination with pharmacotherapy, would benefit from an experimental medicine approach where various parameters, dosing, duration, intensity, etc., are tested against a variety of constructs (e.g., cognitive constructs)
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From page 13... ...
. • Animal studies could enable investigators to examine the effects of combining pharmacologic agents with non-invasive neuromodulation, both to design combination trials where neuromodulation and pharmacotherapy are complementary, and to avoid drugs that may interfere with a desired neuromodulation effect (Rotenberg)
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. POLICY ISSUES AND POTENTIAL OPPORTUNITIES3 During the workshop presentations and discussions, many participants identified issues and potential opportunities related to ethical, legal, and social issues; the regulation of non-invasive neuromodulation devices; reimbursement for treatment using these devices; the business environment in which these devices are being developed; and education/awareness about these devices among clinicians, the general public, and others.
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. • The DIY movement raises questions about the responsibility of researchers to educate the public (Maslen)
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. • For sponsors seeking regulatory approval of devices in the United States, the FDA has encouraged the use of new tools, including innovative clinical trial designs, adaptive trials, and modeling and simulation (Connor)
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. • Health plans individually determine whether treatment will be reimbursed based on multiple types of data, research– randomized control trial, population-based, comparative effective (often incomplete or conflicting in this arena)
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However, growth of the industry is hampered by a number of factors, including low awareness of the technology among the broader practitioner base, lack of direct to consumer education, a limited understanding of the mechanism of the effect of these technologies, a lack of funding from federal grant sources, and sometimes unclear regulatory pathways to approval (Demitrack, Maiques, Pande, and others)
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. • Despite excitement in the field, investors have shied away from medical device companies because of unproven business models for some technologies, lack of regulatory predictability, challenges obtaining reimbursement, and the long development time frame for investors to see a return on their investment (Jaffe)
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. Potential Opportunities • Professional societies should take a more active role in establishing practice standards and addressing the needs of practicing clinicians who utilize these technologies (Demitrack)
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