Evidence map›Paper›PMID 35926784›Full record

ArticleBrain stimulation

Post-trial access in implanted neural device research: Device maintenance, abandonment, and cost.

Gabriel Lázaro-Muñoz, Michelle T Pham, Katrina A Muñoz, Kristin Kostick-Quenet, Clarissa E Sanchez, Laura Torgerson, Jill Robinson, Stacey Pereira, Simon Outram, Barbara A Koenig and 7 more

Abstract read
In one paragraph

Article in Brain stimulation. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

23 citing papers in PubMed.

  1. Trial
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  5. Review
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  7. Review
  8. Contemporary Ethical Considerations in Psychiatric Neurosurgery.Stereotactic and functional neurosurgery · 2026
    Review
  9. Building and Sustaining Open-Source Medical Device Projects.IEEE transactions on bio-medical engineering · 2025
    Review
  10. Article
  11. Review
  12. Review
  13. Article
  14. Article
  15. Article
  16. Article
  17. Article
  18. Article
  19. Article
  20. Post-trial access to implantable neural devices: an exploratory international survey.BMJ surgery, interventions, & health technologies · 2024
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors.

Gabriel Lázaro-MuñozCenter for Bioethics, Harvard Medical School, 641 Huntington Avenue, Boston, MA, 02115, United States; Department of Psychiatry, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, United States. Electronic address: glazaro@hms.harvard.edu.
Michelle T PhamCenter for Bioethcis and Social Justice, College of Human Medicine, Michigan State University, East Fee Hall 965 Wilson Road Rm A-126, East Lansing, MI, 48824, United States.
Katrina A MuñozCenter for Medical Ethics and Health Policy, Baylor College of Medicine, One Baylor Plaza, Suite 326D, Houston, TX, 77030, United States.
Kristin Kostick-QuenetCenter for Medical Ethics and Health Policy, Baylor College of Medicine, One Baylor Plaza, Suite 326D, Houston, TX, 77030, United States.
Clarissa E SanchezCenter for Medical Ethics and Health Policy, Baylor College of Medicine, One Baylor Plaza, Suite 326D, Houston, TX, 77030, United States.
Laura TorgersonCenter for Medical Ethics and Health Policy, Baylor College of Medicine, One Baylor Plaza, Suite 326D, Houston, TX, 77030, United States.
Jill RobinsonCenter for Medical Ethics and Health Policy, Baylor College of Medicine, One Baylor Plaza, Suite 326D, Houston, TX, 77030, United States.
Stacey PereiraCenter for Medical Ethics and Health Policy, Baylor College of Medicine, One Baylor Plaza, Suite 326D, Houston, TX, 77030, United States.
Simon OutramProgram in Bioethics, University of California, 490 Illinois Street, San Francisco, CA, 94143, United States.
Barbara A KoenigProgram in Bioethics, University of California, 490 Illinois Street, San Francisco, CA, 94143, United States.
Philip A StarrDepartment of Neurological Surgery, University of California, 400 Parnassus Avenue, San Francisco, CA, 94143, United States.
Aysegul GunduzNorman Fixel Institute for Neurological Diseases, Departments of Neurology and Neurosurgery, University of Florida, 3009 SW Williston Road, Gainesville, FL, 32608, United States; Department of Biomedical Engineering, University of Florida, 1275 Center Drive, Biomedical Science Building, JG56, Gainesville, FL, 32611, United States.
Kelly D FooteNorman Fixel Institute for Neurological Diseases, Departments of Neurology and Neurosurgery, University of Florida, 3009 SW Williston Road, Gainesville, FL, 32608, United States.
Michael S OkunNorman Fixel Institute for Neurological Diseases, Departments of Neurology and Neurosurgery, University of Florida, 3009 SW Williston Road, Gainesville, FL, 32608, United States.
Wayne GoodmanDepartment of Psychiatry and Behavioral Sciences, Baylor College of Medicine, 1977 Butler Blvd Suite E4.100, Houston, TX, 77030, United States.
Amy L McGuireCenter for Medical Ethics and Health Policy, Baylor College of Medicine, One Baylor Plaza, Suite 326D, Houston, TX, 77030, United States.
Peter ZukCenter for Bioethics, Harvard Medical School, 641 Huntington Avenue, Boston, MA, 02115, United States.

Funding

Neuroethics of aDBS Systems Targeting Neuropsychiatric and Movement DisordersR01MH114854 · NIMH · BAYLOR COLLEGE OF MEDICINE · PI GOODMAN, WAYNE K, LAZARO-MUNOZ, GABRIEL · 2017 to 2020
$2.1M
NIMH NIH HHS R01 MH114854
6 · The paper itself

Abstract

backgroundClinical trial participants who benefit from experimental neural devices for the treatment of debilitating and otherwise treatment-resistant conditions are generally not ensured continued access to effective therapy or maintenance of devices at the conclusion of trials. OBJECTIVE/HYPOTHESIS: Post-trial obligations have been extensively examined in the context of drug trials, but there has been little empirical examination of stakeholder perspectives regarding these obligations in the rapidly growing field of neural device research.

methodsThis study examined the perspectives of 44 stakeholders (i.e., 23 researchers and 21 patient-participants) involved in implantable neural device trials.

resultsResearchers were concerned about current post-trial management, identified barriers like cost, and suggested ways to improve the system. Many patient-participants were unaware of whether they would have post-trial access, but most thought they should keep devices if beneficial, and agreed with researchers that more should be done to help them keep and maintain these neural devices.

conclusionTo our knowledge, this is the first in-depth examination of researcher perspectives regarding continued access to experimental neural devices and only the second such examination of patient-participant perspectives. These data can help inform future ethical and policy decisions about post-trial access to implantable neurotechnology.

Indexed as

Continued accessDeep brain stimulationEthicsNeuroethicsNeurotechnologyPost-trial

Identifiers

PMID35926784
PMCPMC9588741

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.