Neurotherapies for diagnostics and treatment—such as electroencephalography (EEG) neurofeedback, single-photon emission computerized tomography (SPECT) imaging for neuropsychiatric evaluation, and off-label/experimental uses of brain stimulation—are continuously being offered to the public outside mainstream healthcare settings. Because these neurotherapies share many key features of complementary and alternative medicine (CAM) techniques—and meet the definition of CAM as set out in Kaptchuk and Eisenberg—here we refer to them as “alternative neurotherapies.” By explicitly linking these alternative neurotherapy practices under a common conceptual (...) framework, this paper draws attention to, and critically considers, the cross-cutting ethical and legal issues related to the provision of these services. The first section of this paper provides an updated empirical overview of uses of SPECT neuropsychiatric evaluations, EEG neurofeedback, and experimental/off-label forms of brain stimulation. Next, drawing on CAM bioethics scholarship, we highlight the pertinent ethical issues in the alternative neurotherapy context, including the truthful representation of evidence base, marketing to vulnerable populations, potential harms, provider competency, and conflicts of interest. Finally, we consider the principal legal issues at stake for the provision of alternative neurotherapies in the U.S., namely those related to licensing and scope-of-practice considerations. We conclude with recommendations for future research in this domain. (shrink)

One of the ethical issues that has been raised recently regarding emerging neurotherapies is that people will be coerced explicitly or implicitly in the workplace or in schools to take cognitive enhancing drugs. This article builds on this discussion by showing how the law may pressure people to adopt emerging neurotherapies. It focuses on a range of private law doctrines that, unlike the criminal law, do not come up very often in neuroethical discussions. Three doctrines—the doctrine of mitigation, (...) the standard of care in negligence, and child custody determinations in family law—are addressed to show how the law may pressure people to consent to treatment by offering a choice between accepting medical treatment and suffering a legal disadvantage. The doctrines considered in this article apply indirect pressure to submit to treatment, unlike court-ordered medical treatment, which applies direct pressure and is not addressed here. The outcome of this discussion is to show that there is a greater range of social pressures that may encourage the uptake of novel neurotherapies than one might initially think. Once treatments that were developed and offered with therapeutic benefits in mind become available, their existence gives rise to unintended legal consequences. This certainly does not mean we should cease developing new therapies that may be of tremendous benefit to patients, but it does raise some questions for physicians and for legal policy-makers. How should physicians, who are required by medical ethical principles to obtain valid consent to treatment, react to a patient’s reluctant consent that is driven by legal pressure? From the legal policy perspective, are our legal doctrines satisfactory or should they be changed because, for example, they unduly promote the collective interest over individual freedom to reject medical treatment or because they channel us toward economically efficient treatments to the detriment of more costly but potentially superior approaches of dealing with behavioural problems? (shrink)

Nagappan, Kalokairinou, and Wexler (2021) raised a serious ethical question: Are off-label practices or direct-to-consumer medical devices offered to public exempted from clinical or research gover...

IntroductionConcussion is a growing public health concern. No uniformly established therapy exists; neurofeedback studies report treatment value. We use infralow frequency neuromodulation to remediate disabling neurological symptoms caused by traumatic brain injury and noted improved outcomes with a novel concussion protocol. Postconcussion symptoms and persistent postconcussion symptoms are designated timelines for protracted neurological complaints following TBI. We performed a retrospective study to explore effectiveness of ILF in PCS/PPCS and investigated the value of using this concussion protocol.MethodPatients with PCS/PPCS seen for (...) their first neurology office visit or received their first neurofeedback session between 1 August 2018 and 31 January 2021 were entered. Outcomes were compared following treatment as usual vs. TAU with ILF neurotherapy. The study cohort was limited to PPCS patients; the TAU+ILF group was restricted further to PPCS patients receiving at least 10 neurotherapy sessions. Within the TAU+ILF group, comparisons were made between those who trained at least 10 sessions using concussion protocol and those who trained for at least 10 sessions of ILF regardless of protocol.ResultsAmong our resultant PPCS cohort leading persistent neurological complaints were headache, memory impairment, and brain fog. PPCS patients in TAU+ILF+CP demonstrated greater net and percent improvement of symptoms compared to PPCS subjects in TAU. PPCS patients in TAU+ILF-CP trended toward significant symptom improvements compared to TAU, and TAU+ILF+CP trended toward greater efficacy than TAU+ILF-CP.ConclusionPPCS patients who received TAU+ILF+CP demonstrated significantly greater improvement as a group when compared to TAU. When used as an integrative modality to treatment as usual in managing patients with PPCS, ILF neuromodulation with use of concussion protocol provided significant symptom improvements. (shrink)