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Development of functional electrical stimulators utilizing cochlear implant technology.

R Davis1, J Patrick, A Barriskill

  • 1Neural Engineering Clinic, 76 Eastern Avenue, 04330, Augusta, ME, USA

Medical Engineering & Physics
|May 10, 2001
PubMed
Summary

Functional electrical stimulation (FES) using cochlear implant technology offers hope for spinal cord injury (SCI) patients. Early trials showed paraplegic subjects could stand and perform tasks, demonstrating FES potential for restoring function.

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Area of Science:

  • Biomedical Engineering
  • Neuroscience
  • Rehabilitation Technology

Background:

  • The concept of functional electrical stimulation (FES) for spinal cord injury (SCI) was proposed in 1983, leveraging multi-channel cochlear implant technology.
  • Initial investigations, including animal experiments and FES stimulator acquisition, were funded by the US Veteran Administration starting in 1984.
  • An Investigational Device Exemption was granted by the US Food and Drug Administration in 1987, paving the way for human trials.

Purpose of the Study:

  • To evaluate the efficacy of functional electrical stimulation (FES) in restoring function for individuals with paraplegia due to spinal cord injury.
  • To assess the feasibility of using modified cochlear implant technology as an FES device for SCI rehabilitation.
  • To document the outcomes of FES implantation in paraplegic subjects, including functional improvements and device performance.

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Main Methods:

  • Development of a multi-channel FES system based on cochlear implant technology.
  • Implantation of FES stimulators in paraplegic subjects with complete thoracic spinal cord lesions.
  • Functional assessment of subjects, including standing ability, task performance, and bladder voiding.
  • Monitoring of device integrity and performance over time.

Main Results:

  • The first implanted subject (2001) with a complete thoracic spinal cord lesion was able to stand and perform one-handed tasks for up to one hour.
  • A subsequent implant in 1998 provided multiple functions, including bladder voiding, for eight months before device failure (internal antenna wire breakage).
  • A modified implant (FES 24-B) was scheduled for implantation in July 2001, indicating ongoing development and iterative design.

Conclusions:

  • Functional electrical stimulation (FES) shows promise for restoring some functions in individuals with spinal cord injury (SCI), enabling activities like standing.
  • Device reliability remains a critical challenge, as evidenced by the antenna wire breakage in the second implant.
  • Continued development and refinement of FES systems, such as the FES 24-B, are necessary to improve long-term efficacy and durability for SCI patients.