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Subject and Family Perspectives from the Central Thalamic Deep Brain Stimulation Trial for Traumatic Brain Injury: Part II

Published online by Cambridge University Press:  18 October 2023

Joseph J. Fins Open the ORCID record for Joseph J. Fins [Opens in a new window] ,
Megan S. Wright ,
Kaiulani S. Shulman ,
Jaimie M. Henderson  and
Nicholas D. Schiff
Joseph J. Fins*
Affiliation:
Division of Medical Ethics, Weill Cornell Medical College, New York, NY, USA Solomon Center for Health Law & Policy, Yale Law School, New Haven, CT, USA
Megan S. Wright
Affiliation:
Division of Medical Ethics, Weill Cornell Medical College, New York, NY, USA School of Law, Pennsylvania State University, State College, PA, USA
Kaiulani S. Shulman
Affiliation:
Division of Medical Ethics, Weill Cornell Medical College, New York, NY, USA
Jaimie M. Henderson
Affiliation:
Department of Neurosurgery, Stanford School of Medicine, Palo Alto, CA, USA
Nicholas D. Schiff
Affiliation:
Division of Medical Ethics, Weill Cornell Medical College, New York, NY, USA Feil Family Brain and Mind Research Institute, Weill Cornell Medical College, New York, NY, USA
*
Corresponding author: Joseph J. Fins; Email: jjfins@med.cornell.edu
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Abstract

This is the second paper in a two-part series describing subject and family perspectives from the CENTURY-S (CENtral Thalamic Deep Brain Stimulation for the Treatment of Traumatic Brain InjURY-Safety) first-in-human invasive neurological device trial to achieve cognitive restoration in moderate to severe traumatic brain injury (msTBI). To participate, subjects were independently assessed to formally establish decision-making capacity to provide voluntary informed consent. Here, we report on post-operative interviews conducted after a successful trial of thalamic stimulation. All five msTBI subjects met a pre-selected primary endpoint of at least a 10% improvement in completion time on Trail-Making-Test Part B, a marker of executive function. We describe narrative responses of subjects and family members, refracted against that success. Interviews following surgery and the stimulation trial revealed the challenge of adaptation to improvements in cognitive function and emotional regulation as well as altered (and restored) relationships and family dynamics. These improvements exposed barriers to social reintegration made relevant by recoveries once thought inconceivable. The study’s success sparked concerns about post-trial access to implanted devices, financing of device maintenance, battery replacement, and on-going care. Most subjects and families identified the need for supportive counseling to adapt to the new trajectory of their lives.

Keywords

brain injurydeep brain stimulationcognitive restorationdisability rightspost-trial obligations
Type
Research Article
Information
Cambridge Quarterly of Healthcare Ethics , First View , pp. 1 - 24
Copyright
© The Author(s), 2023. Published by Cambridge University Press

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References

Notes

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