跳至主要内容
临床试验/NCT07032753
NCT07032753尚未招募不适用

Neuromusculoskeletal Interface for Bionic Arms: A Randomized Crossover Study

Shirley Ryan AbilityLab2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2026年1月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
12
试验地点
2
主要终点
Safety related: Adverse Event reporting

研究概览

简要总结

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.

详细描述

In the past decade, progress has been made in creating stronger, more capable prosthetic devices, with improved control. Similar improvements have been made in prosthesis suspension, which is a critically important factor in both comfort and function of a prosthetic device. While skin-fit suction sockets were considered the state of the art for many years, custom-rolled silicon and instrumented gel-liners are now becoming more common, as they provide improved comfort. However, these approaches still require use of an external socket worn on the residual limb.

The Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) implant system (Integrum AB, Mölndal, Sweden) uses osseointegration (OI) (i.e., a metal implant is placed in the residual bone, which then grows into and integrates with the implant) to provide mechanical attachment of the prosthesis to the skeleton in the residual limb, thus eliminating the need for a socket.

However, obtaining electromyographic (EMG) control signals to enable myoelectric control of a prosthesis, whether it is attached through OI or a conventional socket, requires placement of surface electrodes over residual limb muscles, which has many practical limitations. Surface EMG signals are a complex blend of all local muscle activations and as such have low fidelity. It is difficult to isolate EMG signals from large surface muscles, and it is impossible to separate out signals from small or deep muscles. In addition, surface EMG signals are contaminated by several sources of noise, including ambient electromagnetic interference, motion artifact, and even electrocardiogram signals.

The limitations of surface electrodes may be overcome by surgically implanting the electrodes into the residual limb and placing them directly onto/into the tissue of the target muscle so that the EMG can be recorded directly at the source with improved signal to noise ratio and without disturbances from the external environment. Typically, such an approach would require skin-penetrating leads to convey the EMG signals from the implanted electrodes to the outside of the body to enable myoelectric prosthesis control, making it unsuitable as a permanent solution.

However, in the e-OPRA (electronic OPRA) device, the percutaneous interface of the OPRA Implant is utilized as a conduit for the wired communication between the inside and the outside of the body, eliminating the need for permanent skin penetrating leads and enabling a permanent solution for myoelectric prosthesis control using implanted electrodes. The e-OPRA system (which is not yet commercially available) developed by Integrum AB (Mölndal, Sweden), is built on decades of developing the OPRA system (which is commercially available).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Device Feasibility
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Safety related: Adverse Event reporting

时间窗: Through 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 Testing

时间窗: Month 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 Mapping

时间窗: Month 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.

次要结局

  • Clothespin Relocation Task(Month 11, Month 13, Month 16, Month 19, Month 22)
  • 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)
  • 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)
  • Assessment of Capacity for Myoelectric Control (ACMC)(Month 11, Month 13, Month 16, Month 19, Month 22)
  • Patient-Specific Functional Scale (PSFS):(Month 11, Month 13, Month 16, Month 19, Month 22)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Levi Hargrove

Scientific Chair, Center for Bionic Medicine, Shirley Ryan Abilitylab

Shirley Ryan AbilityLab

研究点 (2)

Loading locations...

相似试验