Myoelectric prosthesis hand grasp control following targeted muscle reinnervation in individuals with transradial amputation.

BACKGROUND: Despite the growing availability of multifunctional prosthetic hands, users' control and overall functional abilities with these hands remain limited. The combination of pattern recognition control and targeted muscle reinnervation (TMR) surgery, an innovative technique where amputated nerves are transferred to reinnervate new muscle targets in the residual limb, has been used to improve prosthesis control of individuals with more proximal upper limb amputations (i.e., shoulder disarticulation and transhumeral amputation). OBJECTIVE: The goal of this study was to determine if prosthesis hand grasp control improves following transradial TMR surgery. METHODS: Eight participants were trained to use a multi-articulating hand prosthesis under myoelectric pattern recognition control. All participated in home usage trials pre- and post-TMR surgery. Upper limb outcome measures were collected following each home trial. RESULTS: Three outcome measures (Southampton Hand Assessment Procedure, Jebsen-Taylor Hand Function Test, and Box and Blocks Test) improved 9-12 months post-TMR surgery compared with pre-surgery measures. The Assessment of Capacity for Myoelectric Control and Activities Measure for Upper Limb Amputees outcome measures had no difference pre- and post-surgery. An offline electromyography analysis showed a decrease in grip classification error post-TMR surgery compared to pre-TMR surgery. Additionally, a majority of subjects noted qualitative improvements in their residual limb and phantom limb sensations post-TMR. CONCLUSIONS: The potential for TMR surgery to result in more repeatable muscle contractions, possibly due to the reduction in pain levels and/or changes to phantom limb sensations, may increase functional use of many of the clinically available dexterous prosthetic hands.

User Performance With a Transradial Multi-Articulating Hand Prosthesis During Pattern Recognition and Direct Control Home Use.

With the increasing availability of more advanced prostheses individuals with a transradial amputation can now be fit with single to multi-degree of freedom hands. Reliable and accurate control of these multi-grip hands still remains challenging. This is the first multi-user study to investigate at-home control and use of a multi-grip hand prosthesis under pattern recognition and direct control. Individuals with a transradial amputation were fitted with and trained to use an OSSUR i-Limb Ultra Revolution with Coapt COMPLETE CONTROL system. They participated in two 8-week home trials using the hand under myoelectric direct and pattern recognition control in a randomized order. While at home, participants demonstrated broader usage of grips in pattern recognition compared to direct control. After the home trial, they showed significant improvements in the Assessment of Capacity for Myoelectric Control (ACMC) outcome measure while using pattern recognition control compared to direct control; other outcome measures showed no differences between control styles. Additionally, this study provided a unique opportunity to evaluate EMG signals during home use. Offline analysis of calibration data showed that users were 81.5% [7.1] accurate across a range of three to five grips. Although EMG signal noise was identified during some calibrations, overall EMG quality was sufficient to provide users with control performance at or better than direct control.

Toward higher-performance bionic limbs for wider clinical use.

Most prosthetic limbs can autonomously move with dexterity, yet they are not perceived by the user as belonging to their own body. Robotic limbs can convey information about the environment with higher precision than biological limbs, but their actual performance is substantially limited by current technologies for the interfacing of the robotic devices with the body and for transferring motor and sensory information bidirectionally between the prosthesis and the user. In this Perspective, we argue that direct skeletal attachment of bionic devices via osseointegration, the amplification of neural signals by targeted muscle innervation, improved prosthesis control via implanted muscle sensors and advanced algorithms, and the provision of sensory feedback by means of electrodes implanted in peripheral nerves, should all be leveraged towards the creation of a new generation of high-performance bionic limbs. These technologies have been clinically tested in humans, and alongside mechanical redesigns and adequate rehabilitation training should facilitate the wider clinical use of bionic limbs.

Direct and indirect impacts of synthetic biology on biodiversity conservation.

The world's biodiversity is in crisis. Synthetic biology has the potential to transform biodiversity conservation, both directly and indirectly, in ways that are negative and positive. However, applying these biotechnology tools to environmental questions is fraught with uncertainty and could harm cultures, rights, livelihoods, and nature. Decisions about whether or not to use synthetic biology for conservation should be understood alongside the reality of ongoing biodiversity loss. In 2022, the 196 Parties to the United Nations Convention on Biological Diversity are negotiating the post-2020 Global Biodiversity Framework that will guide action by governments and other stakeholders for the next decade to conserve the worlds' biodiversity. To date, synthetic biologists, conservationists, and policy makers have operated in isolation. At this critical time, this review brings these diverse perspectives together and emerges out of the need for a balanced and inclusive examination of the potential application of these technologies to biodiversity conservation.

iGEM and Gene Drives: A Case Study for Governance.

Gene drives have already challenged governance systems. In this case study, we explore the International Genetically Engineered Machine (iGEM) competition's experiences in gene drive-related research and lessons in developing, revising, and implementing a governance system. iGEM's experiences and lessons are distilled into 6 key insights for future gene drive policy development in the United States: (1) gene drives deserve special attention because of their potential for widescale impact and remaining uncertainty about how to evaluate intergenerational and transboundary risks; (2) an adaptive risk management approach is logical for gene drives because of the rapidly changing technical environment; (3) review by individual technical experts is limited and may fail to incorporate other forms of expertise and, therefore, must be complemented with a range of alternative governance methods; (4) current laboratory biosafety and biosecurity review processes may not capture gene drive research or its components in practice even if they are covered theoretically; (5) risk management for research and development must incorporate discussions of values and broader implications of the work; and (6) a regular technology horizon scanning capacity is needed for the early identification of advances that could pose governance system challenges.

A novel, low-cost transradial socket fabrication method using mass-producible components and expanding rigid foam.

BACKGROUND: Millions of people in low- and middle-income countries lack access to prosthetic care. A well-fitting, durable socket is important for prosthesis comfort and function, but conventional fabrication techniques require highly trained clinicians and specialized equipment. OBJECTIVES: To increase access to prosthetic care by developing a simple, low-cost socket fabrication method that does not require specialized equipment or electricity, and can be performed by persons with minimal prosthetic training. STUDY DESIGN: Socket fabrication methods and socket function were evaluated in a pilot feasibility study. TECHNIQUE: We describe a rapid method for fabricating a rigid foam socket directly over the residual limb, with a mass producible, strong, cosmetically appealing plastic outer shell. We fabricated sockets for four individuals with unilateral transradial amputations and evaluated socket function. RESULTS: An individual with no formal prosthetic training was able to fabricate sockets and assemble a functional, comfortable prosthesis system within 90 min. All necessary supplies can be provided in a kit for under US$100. DISCUSSION: Further work is required to determine durability, assess comfort, refine suspension methods, and to develop instructional materials. CONCLUSIONS: We developed a simplified, inexpensive method to fabricate sockets on the residual limb using expandable foam with an integrated cosmetic/structural covering (i.e. an exoskeletal system), for persons with transradial amputation. A transradial prosthesis socket can be fabricated in around 90 min. and all necessary materials, tools, and written instructions for fabrication and fitting can be provided in a kit. Specialized equipment and electricity are not required. Instructions for fabrication and fitting can be provided in multiple languages using online videos.

(Broken) Promises of Sustainable Food and Agriculture through New Biotechnologies: The CRISPR Case.

In recent years, the development of diverse CRISPR-based technologies has revolutionized genome manipulation and enabled a broad scientific community in industry, academia, and beyond to redefine research and development for biotechnology products encompassing food, agriculture, and medicine. CRISPR-based genome editing affords tremendous opportunities in agriculture for the breeding of crops and livestock across the food supply chain that could benefit larger portions of the population compared to CRISPR applications in medicine, for example by helping to feed a growing global population, reach sustainability goals, and possibly mitigate the effects of climate change. These promises come alongside concerns of risks and adverse impacts associated with CRISPR-based genome editing and concerns that governance systems that are ill equipped or not well suited to evaluate these risks. The international community will continue to gather, in multiple venues, in the coming years to discuss these concerns. At the same time, responsible research and innovation paradigms also promise to evaluate the risks and benefits better while incorporating broad stakeholder engagement across the research and development process. The CRISPR community therefore must actively engage with these international deliberations, society, and national governance systems that have promised to build better agricultural systems and provide better food products to achieve equitable outcomes while protecting the environment. Without this active engagement, the promises discussed in this paper are sure to be broken.

Realizing Present and Future Promise of DIY Biology and Medicine through a Trust Architecture.

The speed and scale of the COVID-19 pandemic has highlighted the limits of current health systems and the potential promise of non-establishment research such as "DIY" research. We consider one example of how DIY research is responding to the pandemic, discuss the challenges faced by DIY research more generally, and suggest that a "trust architecture" should be developed now to contribute to successful future DIY efforts.

Building biosecurity for synthetic biology.

The fast-paced field of synthetic biology is fundamentally changing the global biosecurity framework. Current biosecurity regulations and strategies are based on previous governance paradigms for pathogen-oriented security, recombinant DNA research, and broader concerns related to genetically modified organisms (GMOs). Many scholarly discussions and biosecurity practitioners are therefore concerned that synthetic biology outpaces established biosafety and biosecurity measures to prevent deliberate and malicious or inadvertent and accidental misuse of synthetic biology's processes or products. This commentary proposes three strategies to improve biosecurity: Security must be treated as an investment in the future applicability of the technology; social scientists and policy makers should be engaged early in technology development and forecasting; and coordination among global stakeholders is necessary to ensure acceptable levels of risk.

Bioengineering horizon scan 2020.

Horizon scanning is intended to identify the opportunities and threats associated with technological, regulatory and social change. In 2017 some of the present authors conducted a horizon scan for bioengineering (Wintle et al., 2017). Here we report the results of a new horizon scan that is based on inputs from a larger and more international group of 38 participants. The final list of 20 issues includes topics spanning from the political (the regulation of genomic data, increased philanthropic funding and malicious uses of neurochemicals) to the environmental (crops for changing climates and agricultural gene drives). The early identification of such issues is relevant to researchers, policy-makers and the wider public.

Articulating 'free, prior and informed consent' (FPIC) for engineered gene drives.

Recent statements by United Nations bodies point to free, prior and informed consent (FPIC) as a potential requirement in the development of engineered gene drive applications. As a concept developed in the context of protecting Indigenous rights to self-determination in land development scenarios, FPIC would need to be extended to apply to the context of ecological editing. Without an explicit framework of application, FPIC could be interpreted as a narrowly framed process of community consultation focused on the social implications of technology, and award little formal or advisory power in decision-making to Indigenous peoples and local communities. In this paper, we argue for an articulation of FPIC that attends to issues of transparency, iterative community-scale consent, and shared power through co-development among Indigenous peoples, local communities, researchers and technology developers. In realizing a comprehensive FPIC process, researchers and developers have an opportunity to incorporate enhanced participation and social guidance mechanisms into the design, development and implementation of engineered gene drive applications.

Pattern recognition and direct control home use of a multi-articulating hand prosthesis.

Although more multi-articulating hand prostheses have become commercially available, replacing a missing hand remains challenging from a control perspective. This study investigated myoelectric direct control and pattern recognition home use of a multi-articulating hand prosthesis for individuals with a transradial amputation. Four participants were fitted with an i-limb Ultra Revolution hand and a Coapt COMPLETE CONTROL system. An occupational therapist provided training for each control style and how to use the various grips. The number of grips available to each individual was determined by clinician and user feedback to optimize both the number of grips available and the reliability of grip selection. Home trial data corresponding to individual usage were recorded. No significant differences were found between direct and pattern recognition control home trials in regards to trial length (p=0.96), days powered on (p=0.21), or total time powered on (p=0.91). There was a higher average number of configured grips for direct control at 4.8 [0.5] compared to 3.8 [0.5] for pattern recognition control, but this difference did not reach significance (p=0.092). Across all hand close movements, users spent a majority of time $(\gt80$%) in one grip when using direct control. For pattern recognition usage was spread across more grips $(\gt45$% time in one grip, 25% time in a 2nd grip, and 20% time in a 3rd grip). Pattern recognition control may provide users with a more intuitive way to select and use the various grips available to them.

Synthetic Biology and the United Nations.

Synthetic biology is a rapidly emerging interdisciplinary field of science and engineering that aims to redesign living systems through reprogramming genetic information. The field has catalysed global debate among policymakers and publics. Here we describe how synthetic biology relates to these international deliberations, particularly the Convention on Biological Diversity (CBD).

Targeted Muscle Reinnervation Treats Neuroma and Phantom Pain in Major Limb Amputees: A Randomized Clinical Trial.

OBJECTIVE: To compare targeted muscle reinnervation (TMR) to "standard treatment" of neuroma excision and burying into muscle for postamputation pain. SUMMARY BACKGROUND DATA: To date, no intervention is consistently effective for neuroma-related residual limb or phantom limb pain (PLP). TMR is a nerve transfer procedure developed for prosthesis control, incidentally found to improve postamputation pain. METHODS: A prospective, randomized clinical trial was conducted. 28 amputees with chronic pain were assigned to standard treatment or TMR. Primary outcome was change between pre- and postoperative numerical rating scale (NRS, 0-10) pain scores for residual limb pain and PLP at 1 year. Secondary outcomes included NRS for all patients at final follow-up, PROMIS pain scales, neuroma size, and patient function. RESULTS: In intention-to-treat analysis, changes in PLP scores at 1 year were 3.2 versus -0.2 (difference 3.4, adjusted confidence interval (aCI) -0.1 to 6.9, adjusted P = 0.06) for TMR and standard treatment, respectively. Changes in residual limb pain scores were 2.9 versus 0.9 (difference 1.9, aCI -0.5 to 4.4, P = 0.15). In longitudinal mixed model analysis, difference in change scores for PLP was significantly greater in the TMR group compared with standard treatment [mean (aCI) = 3.5 (0.6, 6.3), P = 0.03]. Reduction in residual limb pain was favorable for TMR (P = 0.10). At longest follow-up, including 3 crossover patients, results favored TMR over standard treatment. CONCLUSIONS: In this first surgical RCT for the treatment of postamputation pain in major limb amputees, TMR improved PLP and trended toward improved residual limb pain compared with conventional neurectomy. TRIAL REGISTRATION: NCT02205385 at ClinicalTrials.gov.

Developing a Comprehensive, Adaptive, and International Biosafety and Biosecurity Program for Advanced Biotechnology: The iGEM Experience.

Introduction: The international synthetic biology competition iGEM (formally known as the international Genetically Engineered Machines competition) has a dedicated biosafety and biosecurity program. Method: A review of specific elements of the program and a series of concrete examples illustrate how experiences in implementing the program have helped improved policy, including an increasing diversity of sources for genetic parts and organisms, keeping pace with technical developments, considering pathways toward future environmental release, addressing antimicrobial resistance, and testing the efficacy of current biosecurity arrangements. Results: iGEM's program is forward-leaning, in that it addresses both traditional (pathogen-based) and emerging risks both in terms of new technologies and new risks. It is integrated into the technical work of the competition-with clearly described roles and responsibilities for all members of the community. It operates throughout the life cycle of projects-from project design to future application. It makes use of specific tools to gather and review biosafety and biosecurity information, making it easier for those planning and conducting science and engineering to recognize potential risks and match them with appropriate risk management approaches, as well as for specialists to review this information to identify gaps and strengthen plans. Discussion: Integrating an increasingly adaptive risk management approach has allowed iGEM's biosafety and biosecurity program to become comprehensive, be cross-cutting, and cover the competition's life cycle.

Control within a virtual environment is correlated to functional outcomes when using a physical prosthesis.

BACKGROUND: Advances such as targeted muscle reinnervation and pattern recognition control may provide improved control of upper limb myoelectric prostheses, but evaluating user function remains challenging. Virtual environments are cost-effective and immersive tools that are increasingly used to provide practice and evaluate prosthesis control, but the relationship between virtual and physical outcomes-i.e., whether practice in a virtual environment translates to improved physical performance-is not understood. METHODS: Nine people with transhumeral amputations who previously had targeted muscle reinnervation surgery were fitted with a myoelectric prosthesis comprising a commercially available elbow, wrist, terminal device, and pattern recognition control system. Virtual and physical outcome measures were obtained before and after a 6-week home trial of the prosthesis. RESULTS: After the home trial, subjects showed statistically significant improvements (p < 0.05) in offline classification error, the virtual Target Achievement Control test, and the physical Southampton Hand Assessment Procedure and Box and Blocks Test. A trend toward improvement was also observed in the physical Clothespin Relocation task and Jebsen-Taylor test; however, these changes were not statistically significant. The median completion time in the virtual test correlated strongly and significantly with the Southampton Hand Assessment Procedure (p = 0.05, R = - 0.86), Box and Blocks Test (p = 0.007, R = - 0.82), Jebsen-Taylor Test (p = 0.003, R = 0.87), and the Assessment of Capacity for Myoelectric Control (p = 0.005,R = - 0.85). The classification error performance only had a significant correlation with the Clothespin Relocation Test (p = 0.018, R = .76). CONCLUSIONS: In-home practice with a pattern recognition-controlled prosthesis improves functional control, as measured by both virtual and physical outcome measures. However, virtual measures need to be validated and standardized to ensure reliability in a clinical or research setting. TRIAL REGISTRATION: This is a registered clinical trial: NCT03097978 .

A novel gel liner system with embedded electrodes for use with upper limb myoelectric prostheses.

We present the development and evaluation of a gel liner system for upper limb prosthesis users that enables acquisition of electromyographic (myoelectric) control signals through embedded electrodes and flexible, conductive fabric leads. This liner system is constructed using a manufacturing approach rather than by modifying a commercially available liner. To evaluate the efficacy, eight male individuals with transhumeral amputations used this system, with standard myoelectric prostheses, for home trials lasting an average of 7.3 weeks. Before and after the home trials, electrical resistance of the cumulative 218 embedded electrodes and leads within 10 gel liner systems was measured and found to increase slightly (from an average of 13.4 to 27.5 Ω) after usage. While this increase was statistically significant (p = 0.001), all but one of the final resistance values remained low enough to enable consistent myoelectric control. User impressions were evaluated through a questionnaire comparing the liner prototypes to their own myoelectric prosthesis socket interface. Subjects preferred the liner prototype (p = 0.008) over their own system in the clinical areas of comfort, suspension, function, and, especially, ease of use. These results suggest that this gel liner system is a clinically viable option and that it may offer advantages over current clinical technology for users of upper limb myoelectric prostheses.

Innovative Use of Thighplasty to Improve Prosthesis Fit and Function in a Transfemoral Amputee.

BACKGROUND: Excess residual limb fat is a common problem that can impair prosthesis control and negatively impact gait. In the general population, thighplasty and liposuction are commonly performed for cosmetic reasons but not specifically to improve function in amputees. The objective of this study was to determine if these procedures could enhance prosthesis fit and function in an overweight above-knee amputee. METHODS: We evaluated the use of these techniques on a 50-year-old transfemoral amputee who was overweight. The patient underwent presurgical imaging and tests to measure her residual limb tissue distribution, socket-limb interface stiffness, residual femur orientation, lower-extremity function, and prosthesis satisfaction. A medial thighplasty procedure with circumferential liposuction was performed, during which 2,812 g (6.2 lbs.) of subcutaneous fat and skin was removed from her residual limb. Imaging was repeated 5 months postsurgery; functional assessments were repeated 9 months postsurgery. RESULTS: The patient demonstrated notable improvements in socket fit and in performing most functional and walking tests. Her comfortable walking speed increased 13.3%, and her scores for the Sit-to-Stand and Four Square Step tests improved over 20%. Femur alignment in her socket changed from 8.13 to 4.14 degrees, and analysis showed a marked increase in the socket-limb interface stiffness. CONCLUSIONS: This study demonstrates the potential of using a routine plastic surgery procedure to modify the intrinsic properties of the limb and to improve functional outcomes in overweight or obese transfemoral amputees. This technique is a potentially attractive option compared with multiple reiterations of sockets, which can be time-consuming and costly.

Custom, rapid prototype thumb prosthesis for partial-hand amputation: A case report.

BACKGROUND: Due to advancements in three-dimensional printing, custom-made prostheses are becoming more viable options for persons with difficult cases of prosthetic management. The purpose of this article was to develop a custom voluntary-closing, body-powered thumb mechanism for a partial-hand amputee who had amputations of the index finger and thumb on the left, non-dominant hand. Case description and methods: The prosthesis model was manufactured using rapid prototype technology and was developed to provide greater force and functionality, and to decrease overall size compared to traditional hand prostheses. Findings and outcomes: Following device iterations and occupational therapy sessions, the patient achieved higher functionality in performing daily tasks such as cooking and cleaning, and in completing the Box and Blocks test, though some limitations still precluded full acceptance of the device. CONCLUSION: This case study represents a unique approach in the development of custom-made devices that may increase prostheses acceptance rates among partial-hand amputees. Clinical relevance Many partial-hand amputees report experiencing trouble in finding a device that fits their needs. This study highlights the potential of using rapid prototyping technology to design a prosthesis that meets a user's specific desires.