Neuromusculoskeletal Interface for Bionic Arms

NCT07032753 | Not Yet Recruiting DMC FDA Device

• 2 other identifiers: STU002239081UG3NS127063-01A1
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

eOPRA for transhumeral amputees

Outcome Measures

Primary Outcomes (5)

• Safety related: Adverse Event reporting

  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.

  Through study completion for each subject, on average 3 years.

• Effectiveness related: EMG Signal to Noise Ratio Testing

  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.

  Month 11, Month 13, Month 16, Month 19, Month 22

• Effectiveness related: Somatosensory Mapping

  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.

  Month 11, Month 13, Month 16, Month 19, Month 22

• Effectiveness related: EMG Signal to Noise Ratio Testing

  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.

  Month 13, Month 16, Month19, Month 22

• Effectiveness related: Somatosensory Mapping

  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.

  Month 13, Month 16, Month19, Month 22

Secondary Outcomes (7)

• Orthotics and Prosthetics User Survey-Upper Extremity Functional Status (OPUS-UEFS):

  Month 11, Month 13, Month 16, Month 19, Month 22

• Jebsen Test of Hand Function

  Month 11, Month 13, Month 16, Month 19, Month 22

• Clothespin Relocation Task

  Month 11, Month 13, Month 16, Month 19, Month 22

• Modified Box and Block Test

  Month 11, Month 13, Month 16, Month 19, Month 22

• Southhampton Hand Assessment Procedure (SHAP)

  Month 11, Month 13, Month 16, Month 19, Month 22

Study Arms (4)

OPRA implant system

ACTIVE COMPARATOR

OPRA implant with surface EMG and myoelectric prosthesis system.

Device: OPRA

eOPRA implant system

EXPERIMENTAL

eOPRA system with implanted EMG control and myoelectric prosthesis system.

Device: eOPRA

eOPRA system without sensory feedback

ACTIVE COMPARATOR

eOPRA implant system without sensory feedback and myoelectric prosthesis system.

Device: eOPRA without sensory feedback

eOPRA system with sensory feedback

EXPERIMENTAL

eOPRA implant system with sensory feedback and myoelectric prosthesis system.

Device: eOPRA with sensory feedback

Interventions

eOPRA DEVICE

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

Also known as: OPRA

eOPRA implant system

OPRA DEVICE

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

OPRA implant system

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 system 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.

eOPRA system without sensory feedback

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead
• Integrum: collaborator
• Northwestern Memorial Hospital: collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Shirley Ryan Abilitylab

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Amputation, Traumatic; Wounds and Injuries

Study Officials

• Levi Hargrove, PhD

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suzanne B Finucane, MS

CONTACT

312-238-0937; sfinucane@sralab.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientific Chair, Center for Bionic Medicine, Shirley Ryan Abilitylab

Model Details: Investigators propose two randomized cross-over prospective clinical trials, in which each participant serves as his/her own control. Eight individuals with unilateral transhumeral amputations will undergo OI and TMR surgeries (Aim 2). After surgical healing and reinnervation of target muscles, subjects will participate in two clinical trials. Aim 3, subjects randomly assigned to either OPRA (surface EMG) or e-OPRA (implanted EMG) without sensory feedback. After training, subjects perform a set of outcome measures, then take the device home for 3 months with OPRA system (no EMG). They then return to the lab, complete the same outcome measures, then switch to the other system and repeat this protocol. Aim 4 follows the same study design, except that subjects will be randomly allocated to e-OPRA with or without sensory feedback, based on somatosensory maps collected in Aim 3. Subjects will use the same device for each condition and use pattern recognition to control the device.

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: June 24, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2029
• Last Updated: June 24, 2025

Record last verified: 2025-06

Locations

US (1)