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Recommendations on post-trial responsibility in implantable neural device research: a multidisciplinary consensus study.
(BMC Medical Ethics, 2026-05-12) Higgins, Nathan; Blakely, Brette; Everingham, Roland; Gilbert, Frederic; Griffin, Sarah; Harris, Alexander R; Herring, Sally; Ho, Calvin Wai Loon; Hoy, Kate; Kiel-Chisholm, Scott; Koplin, Julian; Lawn, Sharon; McCay, Allan; Phillipson, Nitya; Richards, Bernadette; Rosenfeld, Jeffrey V; Shamsi Gooshki, Ehsan; Viana, John Noel; Gardner, John; Carter, Adrian
The clinical development of implantable neural devices raises complex ethical questions about post-trial responsibilities to participants. Continued support for participants who continue to use investigational implantable neural devices requires ongoing specialist care, technical expertise, access to tertiary clinical infrastructure, and substantial financial resources to pay for the device and related procedures. However, continued access may not be possible if the trial shows no benefit, if financial barriers limit commercial viability, or if safety concerns lead to suspension or early termination. Specific ethical guidance on post-trial responsibility is urgently needed. To address this challenge within the Australian innovation context, we conducted a modified Delphi study with a multidisciplinary panel of 24 experts, including representatives from industry, bioethics, law, neurosurgery, clinical psychology/neuropsychology, clinical research, neural engineering, regulation and governance, and lived experience advocacy. The process involved two workshops and a survey, guided by established RAND/UCLA methods with context-specific modifications. Drawing on prior empirical research and regulatory review, the panel developed 11 consensus recommendations for responsible post-trial practices. All recommendations achieved high levels of agreement and were rated as highly important for addressing ethical risks in the Australian environment. These are the first jurisdiction-specific recommendations of their kind, and we anticipate they will substantially enhance ethical and practical standards for post-trial responsibility in implantable neural device research in Australia and internationally.
Clinical utility and prospective of TMS-EEG: Updated review from an international expert group.
(Clinical Neurophysiology, 2026-01-09) Ziemann U; Bai Y; Baumer FM; Beck MM; Belardinelli P; Belvisi D; Bender S; Bergmann TO; Bortoletto M; Casarotto S; Casula E; Chaves AR; de Andrade DC; Conte A; Daskalakis ZJ; Farzan F; Ferrarelli F; Fitzgerald PB; Gordon PC; Grefkes C; Harquel S; Hernandez-Pavon JC; Hill AT; Hoy KE; Hummel FC; Julkunen P; Kallioniemi E; Keller CJ; Kimiskidis VK; Kirkovski M; Koch G; Leodori G; Lioumis P; Määttä S; Maidan I; Massimini M; Mengel A; Metsomaa J; Miniussi C; Mutanen TP; Noda Y; Ozdemir RA; Raffin E; Rocchi L; Rogasch NC; Rosanova M; Santarnecchi E; Sarasso S; Schabrun SM; Shafi MM; Siebner HR; Tolner EA; Tomasevic L; Tremblay S; Tscherpel C; Veniero D; Versace V; Voineskos D; Vucic S; Zangen A; Zrenner C; Ilmoniemi RJ
Transcranial magnetic stimulation (TMS) is a non-invasive technique to stimulate the brain, while electroencephalography (EEG) is a non-invasive technique to record its electrical activity. Their combined use (TMS-EEG) has been established only relatively recently, after successful development of TMS-compatible EEG amplifiers. TMS-EEG offers the unparalleled opportunity to directly perturb the brain with TMS and simultaneously record its response with EEG. This allows inferences on causal input-output relationships, therefore going critically beyond purely observational techniques, such as resting-state EEG or functional MRI, in the study of brain dynamics. This consensus review updates the work of Tremblay and coworkers [Clin Neurophysiol 2019; 130: 802-844]. Since then, substantial advances have been made in understanding contamination of TMS-EEG signals by physiological and non-physiological artifacts, as well as in developing strategies to avoid or control them. In parallel, new insights have emerged regarding the physiological mechanisms underlying TMS-EEG responses and their diagnostic and prognostic utility in a broad range of psychiatric and neurological disorders. As such, TMS-EEG is rapidly shaping a dynamic new field in clinical neurophysiology and neuroscience. This review provides a critical and comprehensive synthesis of current knowledge, including practical guidance for implementing TMS-EEG in the clinical setting.
Hybrid optogenetic and electrical stimulation of retinal ganglion cells for artificial vision.
(Brain Stimulation, 2025-12-23) Kwan, William C; Brunton, Emma K; Goris, Toon; Begeng, James M; Kameneva, Tatiana; Stoddart, Paul R; Ibbotson, Michael R; Richardson, Rachael T; Tong, Wei
Millions of adults worldwide experience severe visual impairment due to photoreceptor loss from retinal diseases such as retinitis pigmentosa and macular degeneration. Retinal prostheses that provide artificial vision by stimulating the surviving retinal ganglion cells (RGCs) have emerged as a promising therapy. However, all clinically approved retinal prostheses that use electrical stimulation face the issue of electrical spread. As such, the quality of restored vision provided by existing devices has been limited. Optogenetic approaches provide greater spatial precision, however, they have poor temporal properties compared to electrical stimulation.
Two-year decline in performance on the Cerebellar Cognitive Affective Syndrome Scale in spinocerebellar ataxias.
(Journal of Neurology, 2025-12-11) Selvadurai, Louisa P; Lo Giudice, Chiara; Wallis, Sarah; Morgan, James; Kumar, Kishore R; Szmulewicz, David J; Harding, Ian H
Cognitive deficits are observed in a subset of individuals with spinocerebellar ataxias (SCAs); however, there is limited research on the longitudinal trajectory of such deficits. We investigated longitudinal cognitive performance amongst individuals with SCAs relative to controls, and the relationship of change in cognitive performance with change in self-reported function.
Correlation of Electrical Impedance and Evoked Potentials With Properties of the Electrode Interface Using in Situ Block-Face Imaging of the Rat Pelvic Nerve.
(Neuromodulation: Technology at the Neural Interface, 2025-09-30) Payne, Sophie C; Bowman, Christopher; Keast, Janet R; Trang, Ella P; Osborne, Peregrine B; Fallon, James B
Electrical stimulation is an emerging therapy for urologic disorders. The interface between electrode and neural tissue is a critical region of interest given it affects thresholds of neural activation. Measures of electrode impedance are used clinically to estimate tissue fibrosis at the interface; however, the relationship between impedance and fibrosis is not well defined.