Being open minded about neuromodulation trials: Finding success in our "failures".
As part of the efforts of a multi-disciplinary, international working group focused on ethical issues in neuromodulation for neuro-psychiatric disorders, we propose a novel; strategy for study design which iteratively applies new knowledge to on-going and future trials. Under current practice, device studies may be closed or categorized as "failures" before knowledge embedded in them can be fully mined. We propose the use of an iterative process to gain knowledge from subjects who have responded to those who have not. This approach can help maximize outcomes in non-responders and inform the design of future studies. This more agile yet rigorous methodology leverages information at all stages of investigation and promotes both scientific discovery and; stewardship.
The Consortium for the Advanced Study of Brain Injury, Weill Cornell and Rockefeller University, Solomon Center Distinguished Scholar in Medicine, Bioethics and the Law, Yale Law School, United States.
Joseph J
JJ
Fins
Center for Neurological Restoration, Cleveland Clinic, United States.
Cynthia S
CS
Kubu
Emory University School of Medicine, Depts. of Psychiatry, Neurology and Radiology, United States.
Helen S
HS
Mayberg
Criminal Law and Philosophy of Law, University of Hamburg, Germany.
Reinhard
R
Merkel
Biomedical Sciences KU Leuven, Dept. of Neurosurgery, KU Leuven, Belgium.
Bart
B
Nuttin
Division of Interventional Biological Psychiatry, University Hospital Freiburg, Germany; Department of Psychiatry and Mental Health, The Johns Hopkins University, Baltimore, MD, United States. Electronic address: schlaepf@jhmi.edu.
Thomas E
TE
Schlaepfer
D002986:Clinical Trials as Topic / Q000379:methods*; D006801:Humans; D001523:Mental Disorders / Q000175:diagnosis / Q000628:therapy*; D018377:Neurotransmitter Agents / Q000627:therapeutic use*; D012107:Research Design / Q000639:trends
D018377:Neurotransmitter Agents
Deep brain stimulation; Major depression; Neuroethics; Research methodology