Neuromusculoskeletal Interface for Bionic Arms (NCT07032753)
Neuromusculoskeletal Interface for Bionic Arms: A Randomized Crossover Study
🩺 Plain-English Summary (8th-Grade Level)
The overall objective of this proposal is to perform a first-in-human home trial of the Electronic Osseoanchored Prostheses for the Rehabilitation of Amputees (e-OPRA) implant system in individuals with transhumeral amputations who have had Targeted Muscle Reinnervation (TMR) surgery and use a pattern recognition-controlled myoelectric prosthesis. The purpose of the study is to capture preliminary safety and effectiveness information on the e-OPRA device when used with the prosthetic systems. The investigators expect that the e-OPRA implant system will be safe and provide clinically and statistically significant improvements in control and comfort. Specifically, the investigators hypothesize that the e-OPRA system will (1) allow for training of more functional prosthesis controllers, (2) provide more stable electromyographic (EMG) signals, reducing the need to recalibrate the prosthetic control system, and (3) be more comfortable, as it does not require a tethered arm-band to record surface EMG signals. Phase 1: Perform TMR and e-OPRA surgeries in 8 persons with transhumeral amputations. Phase 2: Perform a randomized cross-over study to compare the OPRA and e-OPRA system (without sensory feedback) in 8 transhumeral amputees who have received TMR. Phase 3: Perform a randomized cross-over study to compare the e-OPRA system with and without sensory feedback in 8 transhumeral amputees who have received TMR.
Who can join: Review the eligibility criteria below.
Location: Shirley Ryan Abilitylab — Chicago, Illinois
Age range: 18 Years to 70 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Shirley Ryan Abilitylab — Chicago, Illinois
📞 Contact the Study Coordinator
Phone: (312) 238-0937
Email: sfinucane@sralab.org
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Amputation
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- GaMA Metric to Quantify Functional Importance of Various Upper Limb Prosthetic Devices — Chicago, Illinois
- Transfemoral Osseointegrated Prosthesis Limb-Load Symmetry Training — Aurora, Colorado
- Magnetic Bead Tracking System and eOPRA Implant System With Bionic Prosthesis for Transtibial Amputees — Boston, Massachusetts
- Personalized Mobility Interventions Using Smart Sensor Resources for Lower-Limb Prosthesis Users — Chicago, Illinois
- Optimizing Prosthetic Prescription to Mitigate the Effects of Perspiration — Seattle, Washington
Explore by condition: All Amputation clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.