Pursuing New Targets and Indications for Deep Brain Stimulation: Considerations for Device-Related Clinical Research in the United States

Abstract:Research participants are entitled to many rights that may easily come into conflict. The most important ones are that researchers respect their autonomy as persons and act on the principles of beneficence, nonmaleficence, and justice. Since 2014, research subjects from numerous states in the United States of America also have a legal “right to try” that allows them, under certain circumstances, to receive experimental (i.e., preliminarily tested) interventions, including medical devices, before official approval from the United States Food and Drug Administration. In the context of experimental interventions, such as deep brain stimulation (DBS) for Alzheimer’s disease, this article argues that research participants ought never to have a legal “right to try” without a corresponding “right to be sure.” The latter refers to external epistemic justification construed in terms of reliance on reliable evidence. This article demonstrates that the mere complexity of intervention ensembles, as in the case of DBS for Alzheimer’s disease which serves as a paradigm example, illustrate how unanswered and/or unasked open questions give rise to a “combinatorial explosion” of uncertainties that require epistemic responses that no single research team alone is likely able to provide. From this assessment, several epistemic asymmetrical relations between researchers and participants are developed. By elucidating these epistemic asymmetries, this article unravels the reasons why open science, transparent exhaustive data reporting, preregistration, and continued constant critical appraisal via pre- and postpublication peer review are not scientific virtues of moral excellence but rather ordinary obligations of the scientific work routine required to increase reliability and strength of evidence.

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Survey of practice preferences in deep brain stimulation surgery in the United States

Interdisciplinary Neurosurgery ◽

10.1016/j.inat.2021.101463 ◽

2021 ◽

pp. 101463

Author(s):

Sasha Howell ◽

Borna E. Tabibian ◽

James H. Mooney ◽

Nicholas J. Erickson ◽

Harrison Walker ◽

...

Keyword(s):

United States ◽

Deep Brain Stimulation ◽

Brain Stimulation ◽

The United States ◽

Deep Brain Stimulation Surgery ◽

Deep Brain

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How Neuropsychiatric Comorbidity, Modulatory Indication, Demographics, and Other Factors Impact Deep Brain Stimulation Inpatient Outcomes in the United States: A Population-Based Study of 27,956 Patients

Clinical Neurology and Neurosurgery ◽

10.1016/j.clineuro.2021.106842 ◽

2021 ◽

pp. 106842

Author(s):

Michael W. Kortz ◽

Brian M. Kongs ◽

Edwin McCray ◽

Fabio Grassia ◽

Patrick Hosokawa ◽

...

Keyword(s):

United States ◽

Deep Brain Stimulation ◽

Brain Stimulation ◽

The United States ◽

Population Based ◽

Population Based Study ◽

Inpatient Outcomes ◽

Deep Brain

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Towards the Next Generation of Deep Brain Stimulation Therapies: Technological Advancements, Computational Methods, and New Targets

10.3389/978-2-88971-464-3 ◽

2021 ◽

Keyword(s):

Deep Brain Stimulation ◽

Computational Methods ◽

Brain Stimulation ◽

Next Generation ◽

New Targets ◽

Deep Brain

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Deep brain stimulation treatment in dystonia: a bibliometric analysis

Arquivos de Neuro-Psiquiatria ◽

10.1590/0004-282x20200016 ◽

2020 ◽

Vol 78 (9) ◽

pp. 586-592

Author(s):

Clarice LISTIK ◽

Eduardo LISTIK ◽

Rubens Gisbert CURY ◽

Egberto Reis BARBOSA ◽

Manoel Jacobsen TEIXEIRA ◽

...

Keyword(s):

Deep Brain Stimulation ◽

Bibliometric Analysis ◽

Brain Stimulation ◽

The United States ◽

Scientific Journals ◽

Long Term Outcomes ◽

Generalized Dystonia ◽

Research Domain ◽

Deep Brain

ABSTRACT Background: Dystonia is a heterogeneous disorder that, when refractory to medical treatment, may have a favorable response to deep brain stimulation (DBS). A practical way to have an overview of a research domain is through a bibliometric analysis, as it makes it more accessible for researchers and others outside the field to have an idea of its directions and needs. Objective: To analyze the 100 most cited articles in the use of DBS for dystonia treatment in the last 30 years. Methods: The research protocol was performed in June 2019 in Elsevier’s Scopus database, by retrieving the most cited articles regarding DBS in dystonia. We analyzed authors, year of publication, country, affiliation, and targets of DBS. Results: Articles are mainly published in Movement Disorders (19%), Journal of Neurosurgery (9%), and Neurology (9%). European countries offer significant contributions (57% of our sample). France (192.5 citations/paper) and Germany (144.1 citations/paper) have the highest citation rates of all countries. The United States contributes with 31% of the articles, with 129.8 citations/paper. The publications are focused on General outcomes (46%), followed by Long-term outcomes (12.5%), and Complications (11%), and the leading type of dystonia researched is idiopathic or inherited, isolated, segmental or generalized dystonia, with 27% of articles and 204.3 citations/paper. Conclusions: DBS in dystonia research is mainly published in a handful of scientific journals and focused on the outcomes of the surgery in idiopathic or inherited, isolated, segmental or generalized dystonia, and with globus pallidus internus as the main DBS target.

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