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Readiness for First-In-Human Neuromodulatory Interventions.

Iris Coates McCall1, Nicole Minielly1, Allison Bethune2,3

  • 1Neuroethics Canada, Division of Neurology, Department of Medicine, University of British Columbia, Vancouver, BC, Canada.

The Canadian Journal of Neurological Sciences. Le Journal Canadien Des Sciences Neurologiques
|June 5, 2020
PubMed
Summary

Translational readiness for novel neurointerventions requires evaluating numerous factors. Patient and clinician values significantly influence decision-making for first-in-human (FIH) trials.

Keywords:
First-in-HumanNeuroethicsNeuromodulation

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Area of Science:

  • Neuroscience
  • Biotechnology
  • Medical Devices

Background:

  • Novel neurointerventions offer therapeutic potential for treatment-refractory disorders.
  • Assessing translational readiness is crucial for first-in-human (FIH) neuromodulatory trials.

Purpose of the Study:

  • To characterize factors defining translational readiness for FIH neuromodulatory trials.
  • To explore stakeholder perspectives on decision-making for neuromodulation.

Main Methods:

  • A two-part methodology was employed: a scoping review of the literature and semi-structured interviews with stakeholders.
  • Magnetic resonance-guided focused ultrasound served as a case example for neuromodulation decision-making.

Main Results:

  • 130 factors relevant to FIH readiness were identified, including trial design, preclinical evidence adequacy, and risk.
  • Neurointervention literature emphasized target organ, target function, and animal model limitations.
  • Stakeholder interviews revealed divergent values and priorities between patients and clinicians.

Conclusions:

  • Translational readiness for neurotechnology FIH trials is multifactorial, integrating clinical and nonclinical priorities.
  • Perceptions and values significantly shape the readiness assessment for neurointerventions.