RecruitingNot ApplicableNCT01474148

A Neuroprosthesis for Seated Posture and Balance


Sponsor

VA Office of Research and Development

Enrollment

10 participants

Start Date

Nov 30, 2011

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to evaluate a surgically implanted functional electrical stimulation (FES) system to facilitate stability of the trunk and hips. FES involves applying small electric currents to the nerves, which cause the muscles to contract. This study evaluates how stabilizing and stiffening the trunk with FES can change the way spinal cord injured volunteers sit, breathe, reach, push a wheelchair, or roll in bed.


Eligibility

Min Age: 21 Years

Inclusion Criteria14

  • C4-T12
  • ASIA Scale A through C
  • Time post injury greater than 6 months
  • Innervated and excitable trunk and pelvis musculature
  • Absence of acute or chronic psychological problems or chemical dependency
  • Range of motion within normal limits
  • Controlled spasticity and absence of hip flexion and adduction spasm
  • Height and weight within normal limits
  • No history of balance problems or spontaneous falls
  • No history of spontaneous fracture or evidence low bone density
  • No acute orthopaedic problems
  • No acute medical complications
  • Adequate social support and stability
  • Able to speak and read English

Exclusion Criteria2

  • Pregnancy
  • Non-English speaking

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Interventions

DEVICEIRS-8 (8-Channel implanted stimulator-telemeter)

Surgical implantation of the 8-channel neuroprosthesis


Locations(1)

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, United States

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NCT01474148


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