Purpose-The purpose of this study was evaluate the potential of a second-generation implantable neuroprosthesis that provides improved control of hand grasp and elbow extension for individuals with cervical level spinal cord injury. The key feature of this system is that users control their stimulated function through electromyographic (EMG) signals.Methods-The second-generation neuroprosthesis consists of 12 stimulating electrodes, 2 EMG signal recording electrodes, an implanted stimulator-telemeter device, an external control unit, and a transmit/receive coil. The system was implanted in a single surgical procedure. Functional outcomes for each subject were evaluated in the domains of body functions and structures, activity performance, and societal participation.Results-Three individuals with C5/C6 spinal cord injury received system implantation with subsequent prospective evaluation for a minimum of 2 years. All 3 subjects demonstrated that EMG signals can be recorded from voluntary muscles in the presence of electrical stimulation of nearby muscles. Significantly increased pinch force and grasp function was achieved for each subject. Functional evaluation demonstrated improvement in at least 5 activities of daily living using the Activities of Daily Living Abilities Test. Each subject was able to use the device at home. There were no system failures. Two of 6 EMG electrodes required surgical revision because of suboptimal location of the recording electrodes.Conclusions-These results indicate that a neuroprosthesis with implanted myoelectric control is an effective method for restoring hand function in midcervical level spinal cord injury.
Type of study/level of evidence-Therapeutic IV.Keywords functional electrical stimulation; neuroprosthesis; spinal cord injury; electromyography; activities of daily livingThe Ability To Grasp And Manipulate objects is an important factor in determining if the tetraplegic individual can regain independence and return to a functional role in society. Implantable functional electrical stimulation systems, or neuroprostheses, provide hand and arm function that is both versatile and transparent. These systems have evolved from the feasibility stage through clinical evaluation in an outpatient population to a Food and DrugCorresponding author: Kevin L. Kilgore, PhD, MetroHealth Medical Center, Hamann 601, 2500 MetroHealth Dr., Cleveland, OH 44109; e-mail: klk4@case.edu.
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NIH-PA Author ManuscriptAdministration (FDA)-approved medical product. 1 Neuroprostheses provide the user with increased independence, thus improving the opportunity for a better quality of life.A first-generation upper-extremity neuroprosthesis (NP) for hand control 2 was first implanted in 1986 3 and became known as the Freehand System. [4][5][6][7][8][9][10][11][12] The Freehand NP (NeuroControl Corp., Valley View, OH) used an 8-channel implanted receiver-stimulator with 8 epimysial or intramuscular forearm and hand electrodes, leads...