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Implanted motor neuroprostheses offer significant restoration of function for individuals with spinal cord injury. Providing adequate user control for these devices is a challenge but is crucial for successful performance. Electromyographic (EMG) signals can serve as effective control sources, but the number of above-injury muscles suitable to provide EMG-based control signals is very limited. Previous work has shown the presence of below-injury volitional myoelectric signals even in subjects diagnosed with motor complete spinal cord injury. In this case report, we present a demonstration of a hand grasp neuroprosthesis being controlled by a user with a C6 level, motor complete injury through EMG signals from their toe flexor. These signals were successfully translated into a functional grasp output, which performed similarly to the participant’s usual shoulder position control in a grasp-release functional test. This proof-of-concept demonstrates the potential for below-injury myoelectric activity to serve as a novel form of neuroprosthesis control.

Implantable motor neuroprostheses can restore functionality to individuals with neurological disabilities by electrically activating paralyzed muscles in coordinated patterns. The typical design of neuroprosthetic systems relies on a single multi-use device, but this limits the number of stimulus and sensor channels that can be practically implemented. To address this limitation, a modular neuroprosthesis, the “Networked Neuroprosthesis” (NNP), was developed. The NNP system is the first fully implanted modular neuroprosthesis that includes implantation of all power, signal processing, biopotential signal recording, and stimulating components. This paper describes the design of stimulation and recording modules, bench testing to verify stimulus outputs and appropriate filtering and recording, and validation that the components function properly while implemented in persons with spinal cord injury. The results of system testing demonstrated that the NNP was functional and capable of generating stimulus pulses and recording myoelectric, temperature, and accelerometer signals. Based on the successful design, manufacturing, and testing of the NNP System, multiple clinical applications are anticipated.

Background: Spinal cord injury (SCI) occurring at the cervical levels can result in significantly impaired arm and hand function. People with cervical-level SCI desire improved use of their arms and hands, anticipating that regained function will result in improved independence and ultimately improved quality of life. Neuroprostheses provide the most promising method for significant gain in hand and arm function for persons with cervical-level SCI. Neuroprostheses utilize small electrical currents to activate peripheral motor nerves, resulting in controlled contraction of paralyzed muscles. Methods: A myoelectrically-controlled neuroprosthesis was evaluated in 15 arms in 13 individuals with cervical-level SCI. All individuals had motor level C5 or C6 tetraplegia. Results: This study demonstrates that an implanted neuroprosthesis utilizing myoelectric signal (MES)–controlled stimulation allows considerable flexibility in the control algorithms that can be utilized for a variety of arm and hand functions. Improved active range of motion, grip strength, and the ability to pick up and release objects were improved in all arms tested. Adverse events were few and were consistent with the experience with similar active implantable devices. Conclusion: For individuals with cervical SCI who are highly motivated, implanted neuroprostheses provide the opportunity to gain arm and hand function that cannot be gained through the use of orthotics or surgical intervention alone. Upper extremity neuroprostheses have been shown to provide increased function and independence for persons with cervical-level SCI.

Background. Previous studies have demonstrated the presence of intact axons across a spinal cord lesion, even in those clinically diagnosed with complete spinal cord injury (SCI). These axons may allow volitional motor signals to be transmitted through the injury, even in the absence of visible muscle contraction. Objective. To demonstrate the presence of volitional electromyographic (EMG) activity below the lesion in motor complete SCI and to characterize this activity to determine its value for potential use as a neuroprosthetic command source. Methods. Twenty-four subjects with complete (AIS A or B), chronic, cervical SCI were tested for the presence of volitional below-injury EMG activity. Surface electrodes recorded from 8 to 12 locations of each lower limb, while participants were asked to attempt specific movements of the lower extremity in response to visual and audio cues. EMG trials were ranked through visual inspection, and were scored using an amplitude threshold algorithm to identify channels of interest with volitional motor unit activity. Results. Significant below-injury muscle activity was identified through visual inspection in 16 of 24 participants, and visual inspection rankings were well correlated to the algorithm scoring. Conclusions. The surface EMG protocol utilized here is relatively simple and noninvasive, ideal for a clinical screening tool. The majority of subjects tested were able to produce a volitional EMG signal below their injury level, and the algorithm developed allows automatic identification of signals of interest. The presence of this volitional activity in the lower extremity could provide an innovative new command signal source for implanted neuroprostheses or other assistive technology.

Purpose The purpose of this study was to 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.

Yu DT, Chae J, Walker ME, Hart RL, Petroski GF. Comparing stimulation-induced pain during percutaneous (intramuscular) and transcutaneous neuromuscular electric stimulation for treating shoulder subluxation in hemiplegia. Arch Phys Med Rehabil 2001;82:756-60. Objective: To determine whether percutaneous (intramuscular) neuromuscular electric stimulation (perc-NMES) is less painful than transcutaneous neuromuscular electric stimulation (trans-NMES) for treating shoulder subluxation in hemiplegia. Design: Double-blind, crossover trial. Setting: University-affiliated tertiary care hospital. Participants: A convenience sample of 10 hemiplegic subjects with at least 1 fingerbreadth of glenohumeral subluxation. Interventions: All subjects received 3 randomly ordered pairs of perc-NMES and trans-NMES to the supraspinatus and posterior deltoid muscles of the subluxated shoulder. Both types of stimulation were optimized to provide full joint reduction with minimal discomfort. Main Outcome Measures: Pain was assessed after each stimulation with a 10-cm visual analog scale (VAS) and the McGill Pain Questionnaire, using the Pain Rating Index (PRI) scoring method. Subjects were asked which type of stimulation they would prefer for 6 weeks of treatment. Wilcoxon's signed-rank test was used to compare median differences in VAS and PRI between perc-NMES and trans-NMES. Results: Median VAS scores for perc-NMES and trans-NMES were 1 and 5.7, respectively ( p =.007). Median PRI scores for perc-NMES and trans-NMES were 7 and 19.5, respectively ( p =.018). Nine of the 10 subjects preferred perc-NMES to trans-NMES for treatment. Conclusion: Data suggest that perc-NMES is less painful than trans-NMES in the treatment of shoulder subluxation in hemiplegia.

We evaluated the differences in selectivity and sensitivity of intramuscular fine-wire electrodes and transcutaneous electrodes in detecting dynamic electromyography (EMG) signals from extensor digitorum (EDC) and extensor carpi radialis (ECR) muscles during isolated EDC and ECR contractions in two able-bodied subjects. Intramuscular fine-wire electrodes differentiated EDC and ECR EMG activities better than transcutaneous electrodes, and intramuscular fine-wire electrodes recorded higher amplitude signals than transcutaneous electrodes. Data suggest that intramuscular fine-wire electrodes are more selective and sensitive than transcutaneous electrodes in detecting EMG signals from adjacent forearm muscles.

Neuromuscular stimulation may facilitate motor recovery after stroke or brain injury, reduce shoulder pain associated with hemiplegia, and reduce cerebral spasticity. However, the discomfort of surface neuromuscular stimulation significantly limits the clinical implementation of this modality for persons with hemiplegia. The study contained herein tests the hypothesis that stroke and brain injury survivors with chronic hemiplegia (>6 mo) and intact sensation tolerate percutaneous intramuscular stimulation better than surface stimulation. Four stroke and two traumatic brain injury survivors participated in the study contained within this article. Each subject received three pairs of percutaneous and surface stimulations of the paretic finger extensors. The order of the type of stimulation within each pair was randomly assigned. The stimulation parameters for each type of stimulation were normalized to produce the same torque at the metacarpophalangeal joint. Subjects rated their perceived level of discomfort using a 10-cm visual analog scale and the McGill Pain Questionnaire. A blinded evaluator administered the pain measures. Percutaneous stimulation was associated with significantly lower discomfort as reflected by the visual analog scale (0.74 v 3.3; 95% confidence interval of difference, -3.84, -1.28). The McGill Pain Questionnaire produced similar results with percutaneous stimulation associated with a significantly fewer number of words chosen to describe the discomfort (0.87 v 3.30; 95% confidence interval of difference, -3.50, -1.30) and significantly lower Pain Rating Index (1.47 v 6.27; 95% confidence interval of difference, -7.77, -1.83). Data suggest that percutaneous intramuscular stimulation is significantly better tolerated than surface stimulation and that percutaneous stimulation may enhance patient compliance with neuromuscular stimulation treatments.

An implanted neuroprosthesis supplying functional neuromuscular stimulation was used to provide grasp and release to tetraplegic individuals. This article describes the results, at a minimum of three years, for the first five patients to have operative implantation of an eight-channel stimulator-receiver. All of the patients had a clinically complete spinal cord injury with motor function remaining at the level of the fifth or sixth cervical nerve root. In addition to implantation of the stimulator system, each patient had augmentative operations on the hand to improve function. The procedures included tendon transfers, side-to-side tendon anastomoses, arthrodesis of the interphalangeal joint of the thumb, and rotational osteotomy of the radius. The neuroprosthesis provides two grasp patterns controlled by voluntary motion of the shoulder or wrist. Functional evaluations included measurement of pinch force, a grasp-release test, evaluation of the level of functional independence, and usage surveys. Pinch force ranged from eight to twenty-five newtons. All five patients demonstrated functional grasp patterns, had increased independence, and were able to use the neuroprosthesis at home on a regular basis. The implanted stimulator has proved to be safe and reliable, with seven years as the longest time in situ at the time of writing.

An implantable stimulator-telemeter (IST-12) was developed for applications in neuroprosthetic restoration of limb function in paralyzed individuals. The IST-12 provides 12 stimulation channels and two myoelectric signal (MES) channels. The MES circuitry includes a two-channel multiplexer, preamplifier, variable gain amplifier/bandpass filter, full-wave rectifier, and bin integrator. Power and control signals are transmitted from an external control unit to the IST-12 through an inductive link. Recorded MES signals are telemetered back to the external control unit through the same inductive link. Following bench testing, one device was implanted chronically in a dog for 15 months and evaluated. Conditions were identified in which MES could be recorded with minimal stimulus artifact. The ability to record MES in the presence of stimulation was verified, confirming the potential of the IST-12 to be used as a myoelectric controlled neuroprosthesis.

A second generation implantable neuroprosthesis has been developed which provides improved control of grasp-release, forearm pronation, and elbow extension for individuals with cervical level spinal cord injury. In addition to the capacity to stimulate twelve muscles, the key technological feature of the advanced system is the capability to transmit data out of the body. This allows the use of myoelectric signal recording via implanted electrodes, thus minimizing the required external components. Clinical studies have been initiated with a second generation neuroprosthesis that consists of twelve stimulating electrodes, two myoelectric signal recording electrodes, an implanted stimulator-telemeter device and an external control unit and transmit/receive coil. This system has now been implemented in nine arms in seven C5/C6 spinal cord injured individuals. The results from these subjects demonstrate that myoelectric signals can be recorded from voluntary muscles in the presence of electrical stimulation of nearby muscles. The functional results show that the neuroprosthesis provides significantly increased pinch force and grasp function for each subject. All subjects have demonstrated increased independence and improved function in activities of daily living. We believe that these results indicate that implanted myoelectric control is a desirable option for neuroprostheses.

Neuroprostheses use electrical stimulation of paralyzed muscles to produce controlled limb movement. A first generation implanted neuroprosthesis for upper extremity function underwent a successful multi-center clinical trial and received FDA approval in 1997. We have now developed a family of second generation implanted neuroprosthetic systems. These systems provide control of grasp-release, forearm pronation, and elbow extension for individuals with cervical level spinal cord injury. The key feature of the advanced system is the capability to transmit data out of the body, allowing the use of implanted control sensors, thus minimizing the required external components. Clinical studies have been initiated with a second generation neuroprosthesis that consists of twelve stimulating electrodes, two myoelectric signal recording electrodes, an implanted stimulator-telemeter device and an external control unit and transmit/receive coil. This system has now been implemented in three C5/C6 spinal cord injured individuals, including one subject with bilateral implants. The results from these three subjects demonstrate that myoelectric signals can be recorded from voluntary muscles in the presence of electrical stimulation of nearby muscles. Myoelectric signals can be used for both discrete and proportional control signals. The results to date are promising, and all subjects have demonstrated improved function using the implanted neuroprosthesis

The purpose of this study was to assess the feasibility of a percutaneous band neuroprosthesis system for stroke survivors. Case reports of 4 chronic stroke survivors who were implanted with percutaneous intramuscular electrodes in various muscles of the forearm for hand grasp and release are presented. A percutaneous hand neuroprosthesis was able to open a spastic hemiparetic hand as long as the upper limb was in a resting position, the wrist and proximal forearm were supported, participants did not try to assist the stimulation, and an individual other than the participant modulated the stimulation. However, when participants tried to assist the stimulation or complete a functional task, hand opening was significantly reduced due to increased finger flexor hypertonia, even with increased stimulation intensity. Similarly, electrically stimulated hand opening was significantly reduced following voluntary hand closure. Techniques that provide real-time modulation of hypertonia with closed loop control, control strategies that are independent of the contralateral limb, and methods to enhance proximal control must be developed to demonstrate the feasibility of a hand neuroprosthesis system for persons with hemiparesis.

Objective To develop and apply an implanted neuroprosthesis to restore arm and hand function to individuals with high level tetraplegia. Design Case study. Setting Clinical research laboratory. Participants Individuals with spinal cord injuries (N=2) at or above the C4 motor level. Interventions The individuals were each implanted with 2 stimulators (24 stimulation channels and 4 myoelectric recording channels total). Stimulating electrodes were placed in the shoulder and arm, being, to our knowledge, the first long-term application of spiral nerve cuff electrodes to activate a human limb. Myoelectric recording electrodes were placed in the head and neck areas. Main Outcome Measures Successful installation and operation of the neuroprosthesis and electrode performance, range of motion, grasp strength, joint moments, and performance in activities of daily living. Results The neuroprosthesis system was successfully implanted in both individuals. Spiral nerve cuff electrodes were placed around upper extremity nerves and activated the intended muscles. In both individuals, the neuroprosthesis has functioned properly for at least 2.5 years postimplant. Hand, wrist, forearm, elbow, and shoulder movements were achieved. A mobile arm support was needed to support the mass of the arm during functional activities. One individual was able to perform several activities of daily living with some limitations as a result of spasticity. The second individual was able to partially complete 2 activities of daily living. Conclusions Functional electrical stimulation is a feasible intervention for restoring arm and hand functions to individuals with high tetraplegia. Forces and movements were generated at the hand, wrist, elbow, and shoulder that allowed the performance of activities of daily living, with some limitations requiring the use of a mobile arm support to assist the stimulated shoulder forces.

Loss of arm and hand function is common after stroke. An implantable, 12-channel, electromyogram (EMG)-controlled functional electrical stimulation neuroprosthesis (NP) may be a viable assistive device for upper-limb hemiplegia. In this study, a research participant 4.8 yr poststroke underwent presurgical screening, surgical installation of the NP, training, and assessment of upper-limb impairment, activity limitation, and satisfaction over a 2.3 yr period. The NP increased active range of finger extension from 3 to 96 degrees, increased lateral pinch force from 16 to 29 N, increased the number of objects from 1 to 4 out of 6 that the participant could grasp and place in a Grasp-Release Test, and increased the Arm Motor Abilities Test score by 0.3 points. The upper-limb Fugl-Meyer score increased from 27 at baseline to 36 by the end of the study. The participant reported using the NP at home 3-4 d/wk, up to 3 h/d for exercise and household tasks. The effectiveness of the NP to assist with activities of daily living was dependent on the degree of flexor tone, which varied with task and level of fatigue. The EMG-based control strategy was not successfully implemented; button presses were used instead. Further advancements in technology may improve ease of use and address limitations caused by muscle spasticity.

Implanted neuroprosthetic systems have been successfully used to provide upper-limb function for over 16 years. A critical aspect of these implanted systems is the safety, stability, and-reliability of the stimulating electrodes and leads. These components are (1) the stimulating electrode itself, (2) the electrode lead, and (3) the lead-to-device connector. A failure in any of these components causes the direct loss of the capability to activate a muscle consistently, usually resulting in a decrement in the function provided by the neuroprosthesis. Our results indicate that the electrode, lead, and connector system are extremely durable. We analyzed 238 electrodes that have been implanted as part of an upper-limb neuroprosthesis. Each electrode had been implanted at least 3 years, with a maximum implantation time of over 16 years. Only three electrode-lead failures and one electrode infection occurred, for a survival rate of almost 99 percent. Electrode threshold measurements indicate that the electrode response is stable over time, with no evidence of electrode migration or continual encapsulation in any of the electrodes studied. These results have an impact on the design of implantable neuroprosthetic systems. The electrode-lead component of these systems should no longer be considered a weak technological link.