Neuromusculoskeletal Interface for Bionic Arms

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Shirley Ryan AbilityLab
Study ID
NCT07032753
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • eOPRA — DEVICE
    Electronic Osseoanchored Prostheses for the Rehabilitation of Amputees (e-OPRA) implant system for transhumeral amputees.
  • OPRA — DEVICE
    Osseoanchored Prostheses for the Rehabilitation of Amputees (e-OPRA) implant system in individuals with transhumeral amputations
  • eOPRA with sensory feedback — DEVICE
    Electronic Osseoanchored Prostheses for the Rehabilitation of Amputees (e-OPRA) implant system in individuals with transhumeral amputations with sensory feedback.
  • eOPRA without sensory feedback — DEVICE
    Osseoanchored Prostheses for the Rehabilitation of Amputees (e-OPRA) implant system in individuals with transhumeral amputations without sensory feedback.

Study Details

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.

Key Dates

Start date
Jan 1, 2026
Status verified
Jun 2025
Primary completion
May 31, 2028
Completion
May 31, 2029

Study Design

Enrollment
12 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Active Comparator: OPRA implant system
    OPRA implant with surface EMG and myoelectric prosthesis system.
  • Experimental: eOPRA implant system
    eOPRA system with implanted EMG control and myoelectric prosthesis system.
  • Active Comparator: eOPRA system without sensory feedback
    eOPRA implant system without sensory feedback and myoelectric prosthesis system.
  • Experimental: eOPRA system with sensory feedback
    eOPRA implant system with sensory feedback and myoelectric prosthesis system.

Primary Outcome Measure

Safety related: Adverse Event reporting [ Time Frame: Through study completion for each subject, on average 3 years. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Shirley Ryan AbilitylabChicagoIllinois60611
Suzanne Finucane, MS
[email protected]
312-238-0937
Levi Hargrove, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Shirley Ryan Abilitylab· Chicago, IL

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