Neuromusculoskeletal Interface for Bionic Arms

Launched by SHIRLEY RYAN ABILITYLAB · Jun 12, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new type of bionic arm system called e-OPRA, designed for people who have had an upper arm amputation above the elbow and have already had a surgery called Targeted Muscle Reinnervation (TMR). The e-OPRA system uses a special implant to connect the prosthetic arm directly to the bone and muscles, which may help users control their prosthetic arm more easily and comfortably compared to current devices. The study aims to see if this new system is safe and if it improves how well people can use their prosthetic arms at home.

People who might be eligible are adults between 18 and 70 years old who have had an amputation above the elbow on one arm and are candidates for both TMR and the e-OPRA implant surgeries. Participants must be able to generate muscle signals to control a myoelectric prosthesis, speak English, and be physically healthy enough for surgery. During the trial, participants will have the surgeries and then try out the e-OPRA system at home, with researchers comparing it to other prosthetic systems. The study will look at how well the device works, how comfortable it is, and how stable the muscle signals are for controlling the arm. This trial is not yet recruiting but hopes to help improve prosthetic technology for people with upper arm amputations in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Between the ages of 18 and 70 years old
• • Unilateral transhumeral level absence
• • Candidate for a myoelectric prosthesis (can generate mV level electromyographic EMG signals as detected by surface electrodes).
• • Candidate for TMR surgery as verified by surgical team
• • Candidate for OPRA surgery as verified by surgical team
• • English speaking
• Exclusion Criteria:
• • Significant new injury that would prevent use of a prosthesis: The ability to consistently wear a prosthesis and perform activities of daily living and specific performance tasks is necessary to evaluate the relative benefits of the interventions.
• • Cognitive impairment sufficient to adversely affect understanding of, or compliance with, study requirements, ability to communicate experiences, or ability to give informed consent: The ability to understand and comply with requirements of the study is essential in order for the study to generate usable, reliable data. The ability to obtain relevant user feedback through questionnaires and informal discussion adds significant value to this study. These cognitive impairments would be confirmed with the Mini-Mental State exam.
• • Proximal nerve injury that would prevent TMR or sensory feedback
• • Significant other comorbidity: Any other medical issues or injuries that would preclude completion of the study, use of the prostheses, or that would otherwise prevent acquisition of useable data by researchers. Examples include: injuries to the shoulder, cervical spine or sound side joint pain that would prohibit the participants from being able use a prosthesis. Medical conditions including unregulated high blood pressure or advanced heart disease that would exclude the participant as an appropriate surgical candidate.
• • Individuals who smoke. This may interfere with the OPRA process from both bone healing and soft tissue standpoints.
• • Individuals with active implants. This has been a restriction of prior FDA IDE to investigate e-OPRA.
• • Pregnant women
• • Non-English speaking