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NCT07032753

Neuromusculoskeletal Interface for Bionic Arms

Sponsor: Shirley Ryan AbilityLab

View on ClinicalTrials.gov

Summary

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.

Official title: Neuromusculoskeletal Interface for Bionic Arms: A Randomized Crossover Study

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-01-01

Completion Date

2029-05-31

Last Updated

2025-06-24

Healthy Volunteers

Conditions

Amputation Amputation, Traumatic Amputation, Surgical Upper Limb Amputation Above Elbow (Injury)

Interventions

DEVICE

eOPRA

Electronic Osseoanchored Prostheses for the Rehabilitation of Amputees (e-OPRA) implant system for transhumeral amputees.

DEVICE

OPRA

Osseoanchored Prostheses for the Rehabilitation of Amputees (e-OPRA) implant system in individuals with transhumeral amputations

DEVICE

eOPRA with sensory feedback

Electronic Osseoanchored Prostheses for the Rehabilitation of Amputees (e-OPRA) implant system in individuals with transhumeral amputations with sensory feedback.

DEVICE

eOPRA without sensory feedback

Osseoanchored Prostheses for the Rehabilitation of Amputees (e-OPRA) implant system in individuals with transhumeral amputations without sensory feedback.

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

Locations (1)

Shirley Ryan Abilitylab

Chicago, Illinois, United States

Clinical Research Directory

Neuromusculoskeletal Interface for Bionic Arms

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (1)