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OBJECTIVE: The Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) believes it is important to help stakeholders (e.g., manufacturers, health-care professionals, patients, patient advocates, academia, and other government agencies) navigate the regulatory landscape for medical devices. For innovative devices involving brain-computer interfaces, this is particularly important. APPROACH: Towards this goal, on 21 November, 2014, CDRH held an open public workshop on its White Oak, MD campus with the aim of fostering an open discussion on the scientific and clinical considerations associated with the development of brain-computer interface (BCI) devices, defined for the purposes of this workshop as neuroprostheses that interface with the central or peripheral nervous system to restore lost motor or sensory capabilities. MAIN RESULTS: This paper summarizes the presentations and discussions from that workshop. SIGNIFICANCE: CDRH plans to use this information to develop regulatory considerations that will promote innovation while maintaining appropriate patient protections. FDA plans to build on advances in regulatory science and input provided in this workshop to develop guidance that provides recommendations for premarket submissions for BCI devices. These proceedings will be a resource for the BCI community during the development of medical devices for consumers.

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STUDY DESIGN: Survey. OBJECTIVE: To measure the utilization of upper extremity reconstructive surgery and the clinicians' perceptions of the outcomes provided for persons with tetraplegia across the Model Spinal Cord (SCI) Injury Systems. SETTING: Model SCI Systems. PARTICIPANTS: A clinician from each of the Model Centers. MAIN OUTCOME MEASURE: A mailed survey eliciting responses with respect to: (1) utilization of upper extremity reconstructive procedures and (2) the clinicians' perceived outcomes of these procedures. RESULTS: In all, 76% responded positively about the availability and appropriateness of upper extremity surgical reconstruction at their center. Of the respondents, 75% felt that surgery recipients were generally satisfied with their surgeries, 80% felt that the surgery made a positive impact on recipients' lives, 81% felt that recipients showed increased independence, and 70% reported a positive impact on recipients' occupation. In all, 93% felt insurance companies should pay for the procedures. Compared to the satisfaction of surgery recipients using a similar instrument, clinicians anticipated slightly greater improvements in all areas except occupation. CONCLUSIONS: There is a positive perception of the benefits of reconstructive surgery for tetraplegia; however, procedures are not routinely offered at all centers. The primary reasons reported for this include the misconception that insurance does not remit payment, that a surgeon is not available, and that surgical candidates are referred to another center.

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OBJECTIVE: To evaluate an implanted neuroprosthesis that allows tetraplegic users to control grasp and release in 1 hand. DESIGN: Multicenter cohort trial with at least 3 years of follow-up. Function for each participant was compared before and after implantation, and with and without the neuroprosthesis activated. SETTING: Tertiary spinal cord injury (SCI) care centers, 8 in the United States, 1 in the United Kingdom, and 1 in Australia. PARTICIPANTS: Fifty-one tetraplegic adults with C5 or C6 SCIs. INTERVENTION: An implanted neuroprosthetic system, in which electric stimulation of the grasping muscles of 1 arm are controlled by using contralateral shoulder movements, and concurrent tendon transfer surgery. Assessed participants' ability to grasp, move, and release standardized objects; degree of assistance required to perform activities of daily living (ADLs), device usage; and user satisfaction. MAIN OUTCOME MEASURES: Pinch force; grasp and release tests; ADL abilities test and ADL assessment test; and user satisfaction survey. RESULTS: Pinch force was significantly greater with the neuroprosthesis in all available 50 participants, and grasp-release abilities were improved in 49. All tested participants (49/49) were more independent in performing ADLs with the neuroprosthesis than they were without it. Home use of the device for regular function and exercise was reported by over 90% of the participants, and satisfaction with the neuroprosthesis was high. CONCLUSIONS: The grasping ability provided by the neuroprosthesis is substantial and lasting. The neuroprosthesis is safe, well accepted by users, and offers improved independence for a population without comparable alternatives.

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Neuroprostheses that electrically stimulate paralyzed muscles provide functional enhancements for individuals with spinal cord injury and stroke such as standing and stepping, reaching and grasping, and bladder and bowel function. For chronic applications, implanted neuroprostheses lead to reliable, low-maintenance and patient-acceptable systems. The advantages of such systems are discussed followed by a generic description of implantable stimulators. Features of current first and second generation neuroprostheses developed at our centre are discussed followed by our experience in the application of these devices in the rehabilitation of individuals with spinal cord injury.

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The rapid pace of recent advances in development and application of electrical stimulation of the nervous system and in neural regeneration has created opportunities to combine these two approaches to restoration of function. This paper relates the discussion on this topic from a workshop at the International Functional Electrical Stimulation Society. The goals of this workshop were to discuss the current state of interaction between the fields of neural regeneration and neural prostheses and to identify potential areas of future research that would have the greatest impact on achieving the common goal of restoring function after neurological damage. Identified areas include enhancement of axonal regeneration with applied electric fields, development of hybrid neural interfaces combining synthetic silicon and biologically derived elements, and investigation of the role of patterned neural activity in regulating various neuronal processes and neurorehabilitation. Increased communication and cooperation between the two communities and recognition by each field that the other has something to contribute to their efforts are needed to take advantage of these opportunities. In addition, creative grants combining the two approaches and more flexible funding mechanisms to support the convergence of their perspectives are necessary to achieve common objectives.

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The lifetime costs associated with spinal cord injury are substantial. Assistive technology that reduces complications, increases independence, or decreases the need for attendant services can provide economic as well as medical or functional benefit. This study describes two approaches for estimating the economic consequences of implanted neuroprostheses utilizing functional electrical stimulation. Life care plan analysis was used to estimate the costs of bladder and bowel care with and without a device restoring bladder and bowel function and to compare these with the costs of implementing the device. For a neuroprosthesis restoring hand grasp, the costs of implementation were compared to the potential savings in attendant care costs that could be achieved by the use of the device. The results indicate that the costs of implementing the bladder and bowel system would be recovered in 5 years, primarily from reduced costs of supplies, medications, and procedures. The costs of the hand grasp neuroprosthesis would be recovered over the lifetime of the user if attendant time was reduced only 2 hours per day and in a shorter time if attendant care was further reduced. Neither analysis includes valuation of the quality of life, which is further enhanced by the neuroprostheses through restoration of greater independence and dignity. Our results demonstrate that implantable neuroprosthetic systems provide good health care value in addition to improved independence for the disabled individual.

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Over the past decade, many laboratories have begun to explore brain-computer interface (BCI) technology as a radically new communication option for those with neuromuscular impairments that prevent them from using conventional augmentative communication methods. BCI's provide these users with communication channels that do not depend on peripheral nerves and muscles. This article summarizes the first international meeting devoted to BCI research and development. Current BCI's use electroencephalographic (EEG) activity recorded at the scalp or single-unit activity recorded from within cortex to control cursor movement, select letters or icons, or operate a neuroprosthesis. The central element in each BCI is a translation algorithm that converts electrophysiological input from the user into output that controls external devices. BCI operation depends on effective interaction between two adaptive controllers, the user who encodes his or her commands in the electrophysiological input provided to the BCI, and the BCI which recognizes the commands contained in the input and expresses them in device control. Current BCI's have maximum information transfer rates of 5-25 b/min. Achievement of greater speed and accuracy depends on improvements in signal processing, translation algorithms, and user training. These improvements depend on increased interdisciplinary cooperation between neuroscientists, engineers, computer programmers, psychologists, and rehabilitation specialists, and on adoption and widespread application of objective methods for evaluating alternative methods. The practical use of BCI technology depends on the development of appropriate applications, identification of appropriate user groups, and careful attention to the needs and desires of individual users. BCI research and development will also benefit from greater emphasis on peer-reviewed publications, and from adoption of standard venues for presentations and discussion.

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Cortical signals might provide a potential means of interfacing with a neuroprosthesis. Guidelines regarding the necessary control features in terms of both performance characteristics and user requirements are presented, and their implications for the design of a first generation cortical control interface for a neuroprosthesis are discussed.

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The feasibility of using the EEG signal to operate a hand grasp neuroprosthesis was investigated. Two able-bodied subjects and one neuroprosthesis user were trained to control the amplitude of the beta rhythm recorded over the frontal areas. After 6 months, all subjects exhibited a high level of control, being able to use this signal to move a cursor to targets on a computer screen with a high (>90%) accuracy rate. Control over the EEG signal was unaffected by upper extremity movement or electrical activation of the muscles, indicating that this signal would be adequate for neuroprosthetic use. To test this concept, the neuroprosthesis user operated his system with the cortical signal, and was able to effectively manipulate several objects.

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An implantable joint angle transducer (IJAT) was developed to provide command-control and feedback-control information for chronic use with functional neuromuscular stimulation (FNS) neuroprostheses. The IJAT uses Hall effect sensors to transduce joint angle. A titanium encapsulated array of Hall effect sensors and support circuitry is surgically implanted in one bone, and a similarly encapsulated permanent magnet in an opposing bone, across a joint. The IJAT provides consistent, reliable, high quality signals that reflect joint movement from midsized two-degree-of-freedom joints. IJAT's were implanted using a chronic in vivo dog model to demonstrate the feasibility of implantation and periodic measurement techniques, and to validate modeling techniques used for prediction of function and calibration. The flexion resolution ranged from 0.4 to 3.0 degrees over a range of 115 degrees. The maximum deviation from a linear response was 9 degrees. The resolution and linearity depend on several transducer and joint geometry parameters, and can be predicted prior to implantation and calibrated after implantation. The results of this study 1) defined the most appropriate hermetic capsule designs for the IJAT sensor and magnet, 2) defined the best orientation of the magnetic field to optimize device function, 3) provided a computer model of the IJAT to aid in placement, calibration, and evaluation of the device, 4) verified the surgical techniques used to implant the device, and 5) verified the long-term functionality and the biocompatibility of the device.

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The composite flexor digitorum profundus muscle has a dual nerve supply from the ulnar nerve (UN) and the anterior interosseous nerve (AIN) but anatomic data regarding the territories of these 2 nerves are limited. In this study, muscles from 20 cadaver forearms were dissected microscopically. The motor nerves were followed to their terminations on individual muscle bellies and the innervation domains mapped. In 75% of cases the AIN supplied the index and middle fingers and the UN supplied the middle, ring, and little fingers; thus, the middle finger had dual innervation. In 20% of cases the AIN went to the index and middle fingers and the UN went to the ring and little fingers. In 5% of cases the AIN went to the index finger and the UN went to the middle, ring, and little fingers. The motor entry points were normalized to the forearm length. The entry points of the UN and AIN branches were at 15% and 30% of forearm length, respectively, distal to the medial epicondyle.

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OBJECTIVE: To relate grant funding activities of the National Center for Medical Rehabilitation Research (NCMRR) with the Center's mission, priorities, and terminology for disability classification. STUDY DESIGN: Retrospective review by the National Advisory Board on Medical Rehabilitation Research (NABMRR). DATA: Abstracts of 153 research proposals and one contract funded by the NCMRR from 1992 through 1996. METHOD: A six-member research group participated in the development of a rating form and related instructions used to evaluate each abstract. The form was piloted and revised, and interrater agreement was monitored. RESULTS: Funded proposals reflected each of the NCMRR priorities evaluated, with the highest proportion in the areas of assistive technology and whole body system, and the lowest in the area of behavioral adaptation. Although some proposals were funded in each of the domains of the disability classification system, proportionately fewer addressed the domains of disability and societal limitations. Findings also indicated that few funded proposals addressed more than one domain in the disability classification system and that most abstracts did not address consumers' perspectives on quality of life. RECOMMENDATIONS: The NABMRR recommended that the NCMRR (1) encourage more research in the areas of disability and societal limitations and in behavioral adaptation, (2) examine funded proposals in light of a recent Institute of Medicine report, and (3) explore quality-of-life measurements. Further, members of the rehabilitation community are encouraged to e-mail their responses to this review to NCMRR staff at (1q2n@nih.govA) and to suggest areas of research emphasis.

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The actions of the dorsal interosseous, volar interosseous, and lumbrical muscles were investigated using applied electrical stimulation and recording the moments that were generated across the metacarpophalangeal joint in flexion/extension and abduction/adduction, the proximal interphalangeal joint in flexion/extension, and the distal interphalangeal joint in flexion/extension. These measurements were made isometrically at various joint angles and levels of stimulation with both able bodied subjects and persons who had sustained tetraplegia. It was determined that the dorsal interossei, including the first, were strong abductors of the fingers and generated a significant moment in metacarpophalangeal (MP) joint flexion and interphalangeal (IP) joint extension. The volar interossei were the primary adductors of the fingers, as well as providing a significant moment in MP joint flexion and IP joint extension. The lumbrical muscles were found to be MP joint flexors and IP joint extensors, although the moments that were generated were on average 70% lower than the interossei. The role of the lumbricals as finger abductors or adductors could not be determined from the data. This information on the actions and moment generating capabilities of the intrinsic muscles led to the incorporation of the interossei into electrically induced hand grasp provided by an implanted neuroprosthesis. The evaluation of the intrinsic muscles in the neuroprosthesis was accomplished by recording the moment generating capabilities of these muscles across each of the joints of the finger. These muscles were capable of generating moments that were 80-90% of the average attained by the able bodied subjects, and have provided a substantial improvement to the electrically induced hand grasp.

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OBJECTIVE: To measure the satisfaction with, clinical impact of, and use of an implantable hand neuroprosthesis. SETTING: Eight different medical centers. PARTICIPANTS: Thirty-four individuals with spinal cord injuries at the C5 or C6 motor level. INTERVENTIONS: Participants were implemented with a hand neuroprosthesis that provides grasp and release. The neuroprosthesis includes a surgically implanted stimulator, implanted electrodes sutured to the hand and forearm muscles, and an externally mounted controller. MAIN OUTCOME MEASURE: A survey was mailed to study participants, who were asked to respond to statements such as "If I had it to do over, I would have the hand system implanted again," using a 5-level Likert scale ("strongly agree" to "strongly disagree"). RESULTS: Eighty-seven percent of participants were very satisfied with the neuroprosthesis, 88% reported a positive impact on their life, 87% reported improvements in activities of daily living, and 81% reported improved independence. Participants reported using the neuroprosthesis a median of 5.5 days per week; 15 participants used the neuroprosthesis 7 days per week, and 5 participants reported not using the device. CONCLUSIONS: The neuroprosthesis was used by most participants. The neuroprosthesis performed satisfactorily, increased users' ability to perform activities of daily living and independence, and improved their quality of life.

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A device capable of simultaneously measuring the isometric moments generated about the metacarpophalangeal (MP), proximal interphalangeal (PIP), and distal interphalangeal (DIP) joints of all four fingers has been developed. The design utilizes a four-bar linkage to transmit moments, but not forces, to the device. This linkage allows the same device to fit a wide range of hand sizes without recalibration. The device was constructed out of aluminum bars which are strapped to each joint segment and to the back of the hand. Strain gauges mounted to the aluminum bars measure the bending moment on the device, which is directly related to the moment applied about the joint center of rotation. Because of the unique design of the device, it is not necessary to have accurate measurements of the joint center of rotation in order to get accurate moment information. A single device is capable of generating independent measurement of MP extension/flexion, PIP extension/flexion, and DIP extension/flexion. Four of these devices can be used to make simultaneous measurements of all the moments generated by all four fingers. The device also acts as a splint, allowing each joint to be positioned and locked at any angle through the range of motion of the joint. The device is accurate to within +/- 5.6% of each reading for moments from 10 N x cm to 100 N x cm and within +/- 2.0 N x cm for moments of 10 N x cm or less. If the device configuration is constrained, the accuracy can be improved to +/- 0.8% of full scale (100 N x cm) and +/- 0.21 N x cm for moments of 10 N x cm or less. The device can measure both flexion and extension moments up to 100 N x cm, and can allow the joints to be fixed at any angle from approximately 10 to 80 degrees.

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We quantitatively investigated the extent of damage to motor neurons in tetraplegic subjects. Numbers of motor units in the patients were significantly lower for thenar, wrist extensor, and biceps brachii as compared to controls. Reduction in counts occurred even when M-response amplitudes were normal. Standard electromyography suggested a surprising frequency of lower motor neuron dysfunction below the level of injury. These results confirm previous reports and add data on motor units in the biceps brachii.

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Spinal cord injury sustained at the C5/C6 level leaves an individual without voluntary control of the muscles of the forearm, hand, or of the elbow extensors. The objective of this research project was to integrate functional neuromuscular stimulation (FNS) control of elbow extension with a previously developed system that provides hand grasp in order to increase the working volume in space in which users can perform functional tasks. Elbow extension control was achieved by detecting the position of the arm in space and determining the magnitude of the gravitational moment acting to oppose extension. An accelerometer was used as the command control source, and this sensor was placed over the ulna near the elbow joint to detect static (gravitational) acceleration, and therefore the gravitational moment acting about the elbow joint. This value determined the level of electrical stimulation required to activate the triceps muscles to full extension against these forces. Combined FNS control of elbow extension and hand grasp was implemented in two quadriplegic subjects. Both subjects were able to reach and grasp objects at locations in space which were unattainable without triceps activation.

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Implanted neuroprostheses employing functional electrical stimulation (FES) provide grasp and release to individuals with tetraplegia. This paper describes and compares three methods of controlling the stimulated hand movement: shoulder position, wrist position and myoelectric activity from the wrist extensors. Three experienced neuroprosthesis users were evaluated with each of the control methods by performing a grasp release test (GRT). A significant improvement was found between each functional electrical stimulation (FES) method and tenodesis without FES. No significant difference in overall performance was found between the three FES methods of control. Each method of control demonstrated advantages and disadvantages which depend upon characteristics of the individual patient. Factors which must be considered are injury level, voluntary wrist strength, proximal upper limb strength, the level of cognition of the patient, hand-grasp characteristics, cosmeses, importance of using both arms, and personal preference. Due to the unique characteristics of each controller type, it is advantageous to have each type available for the FES patients to adapt the system to the needs and desires of the individual patient.

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An implantable integrated stimulator and telemetry system has been developed. The system is capable of fulfilling the stimulus and telemetry needs of advanced functional neuromuscular stimulation (FNS) applications requiring multiple channels of stimulation and multiple channels of sensor or biopotential sensing. This system provides a command control structure, an inductive radio frequency link providing power to the implant device as well as two-way transcutaneous communication, an ASIC for decoding the command and for providing functional control within the implant, and modular circuitry providing the application specific implant functions. Biocompatible hermetic packaging, lead systems, and in-line connectors suitable for long-term implantation, provide encapsulation for the circuitry and access to the electrodes and sensors used in the application. The first implant configuration realized from this modular system is targeted for clinical implementation in persons with tetraplegia at the C6 level for restoration of hand function, using wrist position as the command control source. The implant device realized has ten channels of stimulation and telemetry used to control and sense a joint angle transducer implanted in the radio-carpal joint of the wrist. A prototype device has been fabricated and is undergoing testing in an animal.

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