e-OPRA Implant System for Bionic Arms
This study is testing a new implant system called e-OPRA (Electronic Osseoanchored Prostheses for the Rehabilitation of Amputees) for people with an above-elbow (transhumeral) amputation. The e-OPRA system helps attach a bionic arm directly to your bone, aiming to improve control and comfort compared to traditional sockets. Researchers want to see how safe and effective the e-OPRA system is, especially when used with a specific type of surgery called Targeted Muscle Reinnervation (TMR) and a pattern-recognition controlled bionic arm. They will measure things like how well the arm responds to your muscle signals (EMG Signal to Noise Ratio) and how you feel sensations (Somatosensory Mapping). You might be able to join if you are 18-70 years old, have a unilateral transhumeral amputation, and are a candidate for myoelectric prosthesis, TMR, and OPRA surgery. The study is currently unclear on its recruitment status and plans to enroll 12 participants.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 12 participants.
- What's involved
- You would participate in assessments like EMG signal testing and somatosensory mapping at months 11, 13, 16, 19, and 22. Adverse events will be monitored throughout the study, which averages 3 years.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for safety reporting through study completion, which averages 3 years. Effectiveness will be measured up to month 22.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Neuromusculoskeletal Interface for Bionic Arms
At a glance
Conditions
NCT07032753
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Shirley Ryan Abilitylab
Chicago, Illinoisstudy coordinator listed
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Levi Hargrove, PhD · PRINCIPAL_INVESTIGATOR · Shirley Ryan AbilityLab
Who to contact
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Inclusion
Exclusion
What this trial measures
- Safety related: Adverse Event reportingThrough study completion for each subject, on average 3 years.
The number/percentage of subjects that successfully demonstrate the absence of any Serious Adverse Device Effects will be summarized along with a 95% confidence interval.
- Effectiveness related: EMG Signal to Noise Ratio TestingMonth 11, Month 13, Month 16, Month 19, Month 22
The investigators will quantify the signal-to-noise ratio (SNR) of EMG signals by comparing activity recorded during maximum voluntary contraction (MVC) to that recorded during rest. SNR will be calculated as the ratio of EMG signal power during contraction to the signal power during rest, using a standardized protocol consistent with our preliminary data. Each trial will consist of three repetitions of three-second MVCs, interleaved with three-second rest periods. From each repetition, the central 30% of both the contraction and rest epochs will be extracted to minimize edge effects and ensure steady-state measurement. These extracted segments will then be concatenated across repetitions to create two signal arrays: one representing active EMG and the other representing baseline noise. This metric will be used to evaluate the quality of EMG signal acquisition from both surface and implanted electrodes, and to ensure adequate fidelity for pattern recognition control.
- Effectiveness related: Somatosensory MappingMonth 11, Month 13, Month 16, Month 19, Month 22
The projected field-the region on the phantom limb where an electrically evoked sensation is perceived-for each contact on the implanted spiral nerve cuff electrodes. This mapping will be performed at three stimulation levels: the detection threshold (the lowest amplitude at which a sensation is first perceived) and two suprathreshold amplitudes that fall within a safe, physiologically relevant, and comfortably perceptible range. These amplitudes will allow us to assess the size, intensity, and location of the perceived sensation change with increased stimulation. Projected fields will be recorded on a schematic of the hand and used to build a subject-specific somatotopic map. This map will inform which sensor signals (from the TASKA CX hand) are routed to which nerve cuff contacts during the sensory feedback phases of the study. Contact-response stability will be evaluated over time, as these experiments will be repeated each time outcomes are collected in the study.
- Effectiveness related: EMG Signal to Noise Ratio TestingMonth 13, Month 16, Month19, Month 22
The investigators will quantify the signal-to-noise ratio (SNR) of EMG signals by comparing activity recorded during maximum voluntary contraction (MVC) to that recorded during rest. SNR will be calculated as the ratio of EMG signal power during contraction to the signal power during rest, using a standardized protocol consistent with our preliminary data. Each trial will consist of three repetitions of three-second MVCs, interleaved with three-second rest periods. From each repetition, the central 30% of both the contraction and rest epochs will be extracted to minimize edge effects and ensure steady-state measurement. These extracted segments will then be concatenated across repetitions to create two signal arrays: one representing active EMG and the other representing baseline noise. This metric will be used to evaluate the quality of EMG signal acquisition from both surface and implanted electrodes, and to ensure adequate fidelity for pattern recognition control.
- Effectiveness related: Somatosensory MappingMonth 13, Month 16, Month19, Month 22
The projected field-the region on the phantom limb where an electrically evoked sensation is perceived-for each contact on the implanted spiral nerve cuff electrodes. This mapping will be performed at three stimulation levels: the detection threshold (the lowest amplitude at which a sensation is first perceived) and two suprathreshold amplitudes that fall within a safe, physiologically relevant, and comfortably perceptible range. These amplitudes will allow us to assess the size, intensity, and location of the perceived sensation change with increased stimulation. Projected fields will be recorded on a schematic of the hand and used to build a subject-specific somatotopic map. This map will inform which sensor signals (from the TASKA CX hand) are routed to which nerve cuff contacts during the sensory feedback phases of the study. Contact-response stability will be evaluated over time, as these experiments will be repeated each time outcomes are collected in the study.