Device Removal Following Brain Implant Research

Sierra‐Mercado, Demetrio; Zuk, Peter; Beauchamp, Michael S.; Sheth, Sameer A.; Yoshor, Daniel; Goodman, Wayne K.; McGuire, Amy L.; Lázaro‐Muñoz, Gabriel

doi:10.1016/j.neuron.2019.08.024

Cited by 26 publications

(8 citation statements)

References 5 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…That DBS affords effective clinical benefit can be seen as only an initial component (and hurdle) of successful care. Indeed, there have been-and remain-ethical and policy challenges regarding post-trial management of brain implant devices (Lazaro-Munoz et al, 2018;Sierra-Mercado et al, 2019). Brain implant trials generally do not have provisions to ensure that patients/subjects who gain clinical benefit from the use of DBS will have access to maintenance of the device after completion of the trials.…”

Section: Dbs For Less Prevalent Diseases Continued Access After Trials and The Nih Brain Initiative Ethics Updatesmentioning

confidence: 99%

Proceedings of the Eighth Annual Deep Brain Stimulation Think Tank: Advances in Optogenetics, Ethical Issues Affecting DBS Research, Neuromodulatory Approaches for Depression, Adaptive Neurostimulation, and Emerging DBS Technologies

Vedam‐Mai¹,

Deisseroth²,

Giordano³

et al. 2021

Front. Hum. Neurosci.

Self Cite

View full text Add to dashboard Cite

We estimate that 208,000 deep brain stimulation (DBS) devices have been implanted to address neurological and neuropsychiatric disorders worldwide. DBS Think Tank presenters pooled data and determined that DBS expanded in its scope and has been applied to multiple brain disorders in an effort to modulate neural circuitry. The DBS Think Tank was founded in 2012 providing a space where clinicians, engineers, researchers from industry and academia discuss current and emerging DBS technologies and logistical and ethical issues facing the field. The emphasis is on cutting edge research and collaboration aimed to advance the DBS field. The Eighth Annual DBS Think Tank was held virtually on September 1 and 2, 2020 (Zoom Video Communications) due to restrictions related to the COVID-19 pandemic. The meeting focused on advances in: (1) optogenetics as a tool for comprehending neurobiology of diseases and on optogenetically-inspired DBS, (2) cutting edge of emerging DBS technologies, (3) ethical issues affecting DBS research and access to care, (4) neuromodulatory approaches for depression, (5) advancing novel hardware, software and imaging methodologies, (6) use of neurophysiological signals in adaptive neurostimulation, and (7) use of more advanced technologies to improve DBS clinical outcomes. There were 178 attendees who participated in a DBS Think Tank survey, which revealed the expansion of DBS into several indications such as obesity, post-traumatic stress disorder, addiction and Alzheimer’s disease. This proceedings summarizes the advances discussed at the Eighth Annual DBS Think Tank.

show abstract

Section: Dbs For Less Prevalent Diseases Continued Access After Trials and The Nih Brain Initiative Ethics Updatesmentioning

confidence: 99%

Proceedings of the Eighth Annual Deep Brain Stimulation Think Tank: Advances in Optogenetics, Ethical Issues Affecting DBS Research, Neuromodulatory Approaches for Depression, Adaptive Neurostimulation, and Emerging DBS Technologies

Vedam‐Mai¹,

Deisseroth²,

Giordano³

et al. 2021

Front. Hum. Neurosci.

Self Cite

View full text Add to dashboard Cite

show abstract

“…So with companies unwilling to pay, the cost of removal falls to the participant who has already undergone a lot without promise of benefit. 32 And yet upon removal, companies will often be able to claim ownership of an implant, gaining access to the device and valuable data on how a device responds to being placed within the brain environment.…”

Section: Dovepressmentioning

confidence: 99%

Post-Trial Considerations for an Early Phase Optogenetic Trial in the Human Brain

White¹,

Whittaker²

2022

OAJCT

View full text Add to dashboard Cite

For many clinical trials, the issue of post-trial access to research treatments is straightforward. Sponsors offer a range of follow-on studies, compassionate use programs or expanded access programs to allow participants to continue accessing beneficial experimental treatments. But there are times when this is not always the case and participants are required to stop beneficial treatments and return to standard care. Guidance states that post-trial access should be made available for "those participants who still need an intervention identified as beneficial". This broad statement has allowed sponsors to make their own interpretation of when an intervention is still "needed" and when it is "beneficial". As a result, there have been a number of situations where participants of clinical trials have been left afterwards with feelings of abandonment. Participants involved in studies with long-term, invasive treatments can be seen as being particularly vulnerable. Optogenetic technology has the potential to offer hope to people with neurological conditions, especially people who may not respond to current approved treatments. Optogenetics typically involves two components: a gene therapy medicinal product (GTMP) that induces long-term expression of light-reactive proteins within cells, and an active implantable device to stimulate the light-sensitised cells. Neither works without the other, hence for long-term patient benefit, both must remain active and may therefore require maintenance or replacement. With the potential life-long consequences of both components and the difficulty of accessing the brain, there is a need to reconsider post-trial guidelines and whether they are suitable to support early phase optogenetic trial participants. This paper considers the ethical and regulatory requirements in place for post-trial access and care in relation to optogenetic treatments of neurological conditions. We propose that a new perspective with wider responsibilities for sponsors is required when it comes to these types of novel therapies.

show abstract

“…However, they maintain that this must be weighed against "the feasibility of imposing additional burdens on the research enterprise". They conclude that "researchers should not be obligated to cover costs related to device removal if it is incompatible with the sustainability of the research enterprise that initiates the relationship that grounds the obligation in the first place" [34]. This is a remarkable argument, since it makes the basic rights of research subjects in relation to researchers secondary to the economic viability of the research project.…”

Section: Ending Clinical Trialsmentioning

confidence: 99%

The ethics of explantation

Hansson

2021

BMC Med Ethics

View full text Add to dashboard Cite

Background With the increased use of implanted medical devices follows a large number of explantations. Implants are removed for a wide range of reasons, including manufacturing defects, recovery making the device unnecessary, battery depletion, availability of new and better models, and patients asking for a removal. Explantation gives rise to a wide range of ethical issues, but the discussion of these problems is scattered over many clinical disciplines. Methods Information from multiple clinical disciplines was synthesized and analysed in order to provide a comprehensive approach to the ethical issues involved in the explantation of medical implants. Results Discussions and recommendations are offered on pre-implantation information about a possible future explantation, risk–benefit assessments of explantation, elective explantations demanded by the patient, explantation of implants inserted for a clinical trial, patient registers, quality assurance, routines for investigating explanted implants, and demands on manufacturers to prioritize increased service time in battery-driven implants and to market fewer but more thoroughly tested models of implants. Conclusion Special emphasis is given to the issue of control or ownership over implants, which underlies many of the ethical problems concerning explantation. It is proposed that just like transplants, implants that fulfil functions normally carried out by biological organs should be counted as supplemented body parts. This means that the patient has a strong and inalienable right to the implant, but upon explantation it loses that status.

show abstract

Device Removal Following Brain Implant Research

Cited by 26 publications

References 5 publications

Proceedings of the Eighth Annual Deep Brain Stimulation Think Tank: Advances in Optogenetics, Ethical Issues Affecting DBS Research, Neuromodulatory Approaches for Depression, Adaptive Neurostimulation, and Emerging DBS Technologies

Proceedings of the Eighth Annual Deep Brain Stimulation Think Tank: Advances in Optogenetics, Ethical Issues Affecting DBS Research, Neuromodulatory Approaches for Depression, Adaptive Neurostimulation, and Emerging DBS Technologies

Post-Trial Considerations for an Early Phase Optogenetic Trial in the Human Brain

The ethics of explantation

Contact Info

Product

Resources

About