Risk-benefit value of upper extremity function by an implanted electrical stimulation device targeting chronic cervical spinal cord injury

STUDY DESIGN: A cross-sectional stated-preference survey using direct-assessment questions. OBJECTIVE: To determine the relative value placed on different outcomes to be used in a pivotal trial for the upper extremity configuration of the Networked Neuroprosthesis (NNP) as well as the tolerance of the expected adverse event profile. SETTING: Academic medical center in the United States. METHODS: Distribution of an online survey to adults living with tetraplegia; extent of agreement with each question/statement was obtaining using a 1–7 Likert scale. RESULTS: There were 8 statements about potential benefits in arm/hand function; for all statements, more than 70% of participants rated the functions as “1-very important” to regain. There were variable degrees of concern related to risks that could occur during the 30-day post-surgical period and increasing degrees of concern related to risks that could occur in the first 5 years, potentially due to the device, based on the increasing degree of invasiveness of the intervention required to address the event. When analysing the results based on all degrees of interest, more than 64% of responders were interested in getting the NNP with a success rate threshold as low as 50% regardless of time post-injury. Chi-squared analyses revealed some associations between responses and sex, injury level, and injury duration; however, none of these were statistically significant upon post-hoc analysis. CONCLUSION: Data here indicate that people with tetraplegia are highly interested in a range of arm/hand functions and are tolerant of expected risks that may be associated with implanted neuroprosthetics. SPONSORSHIP: The Institute for Functional Restoration funded this project through a sub-contract to K.D. Anderson from a larger Special Projects Award (grant number FP0020773) from the Craig H. Neilsen Foundation.