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Clinical Trial Designs for Neuromodulation in Chronic Spinal Cord Injury Using Epidural Stimulation

Wiley Publisher

As published in WILEY

We presented a narrative review focused on specific challenges related to adequate controls that arise in neuromodulation clinical trials involving perceptible stimulation and physiological effects of stimulation activation. We presented the strengths and limitations of available clinical trial research designs for the testing of epidural stimulation to improve recovery after spinal cord injury. We also described how studies can control for the placebo effects that arise due to surgical implantation, the physical presence of the battery, generator, control interfaces, and rehabilitative activity aimed to promote use‐dependent plasticity. Ultimately to mitigate Hawthorne effects that may occur in clinical trials with intensive supervised participation, including rehabilitation.

In conclusion, the standard of care control groups fail to control for the multiple effects of knowledge of having undergone surgical procedures, having implanted stimulation systems, and being observed in a clinical trial. The irreducible effects that have been identified as “placebo” require sham controls or comparison groups in which both are implanted with potentially active devices and undergo similar rehabilitative training.

This review was authored by:

  • Maxwell Boakye, MD, MPH, MBA
  • Beatrice Ugiliweneza, PhD, MSPH
  • Fabian Madrigal, MD
  • Samineh Mesbah, PhD
  • Alexander Ovechkin, MD, PhD
  • Claudia Angeli, PhD
  • Ona Bloom, PhD
  • Jill W. Wecht, EdD
  • Bonnie E. Legg Ditterline, PhD
  • Noam Y. Harel, MD, PhD
  • Steven Kirshblum, MD
  • Gail Forrest, PhD
  • Samuel Wu, PhD
  • Susan Harkema, PhD
  • James Guest, MD, PhD

Read the Complete Published Article in WILEY.

Posted in Publications