Ethical Considerations for Deep Brain Stimulation Trials in Patients with Early-Onset Alzheimer’s Disease

Abstract

Several studies of deep brain stimulation (DBS) of the fornix or the nucleus basalis of Meynert have been recently conducted in people with Alzheimer's disease, with several recruiting participants <65 and thus have early-onset Alzheimer's disease (EOAD). Although EOAD accounts for less than 5.5% of AD cases, ethical considerations must still be made when performing DBS trials including these participants since a portion of people with EOAD, especially those possessing autosomal-dominant mutations, have an atypical and more aggressive disease progression. These considerations include appropriate patient selection and signing of an informed consent for genetic testing; appropriate study design; potential outcomes that people with EOAD could expect; and accurate interpretation and balanced discussion of trial results. Finally, recommendations for future DBS for AD trials will be made to ensure that EOAD patients will not experience avoidable harms should they be enrolled in these experimental studies.

The Effects of Closed-Loop Brain Implants on Autonomy and Deliberation: What are the Risks of Being Kept in the Loop?

“…More work is required to fully comprehend the ethical concerns associated with being kept in the loop, as it may share a limited number of concerns with other novel invasive brain technologies or other types of neuro-interventions. 44,45,46,47,48,49,50,51 A further important question to explore would be whether bypassing implanted individual consent by allowing a system to deliver an automated therapeutic response could be ethically acceptable in some cases.…”

I Miss Being Me: Phenomenological Effects of Deep Brain Stimulation

“…This evidence justifies the claim that, generally speaking, DBS is not a threat to personal, but some patients might not experience well any form of estrangement. Patients would benefit from being informed ahead of any potential risks, prior to consenting to being implanted, as in other types of invasive brain intervention (Viaña, Vickers et al 2017;Gilbert et al 2014;Viaña, Bittlinger et al 2017;Gilbert 2015b;Bretzner et al 2011;Gilbert, Vranic, and Hurst 2013;Gilbert 2014;Vranic & Gilbert 2014;Gilbert & Cook 2015;Gilbert 2017;Gilbert & Dodds 2013;Gilbert & Focquaert 2015;Gilbert & Vranic 2015).…”

Aging, Informed Consent and Autonomy: Ethical Issues and Challenges Surrounding Research and Long-Term Care

“…Siegel, Barrett and Bhati [82] argue that investigators undertaking deep brain stimulation experiments on people with Alzheimer's disease must face up to the ethical challenges with "particular attention to elements of subject enrollment and informed consent" (p. 429). For Viaña, Bittlinger and Gilbert [83] future trials on deep brain stimulation for people with Alzheimer's disease should ensure that "patients will not experience avoidable forms of harm should they be enrolled in these experimental trials" (p. 289).…”