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| ID | Type | Description | Link |
|---|---|---|---|
| RX003355-01 | Other Grant/Funding Number | VA RR&D | |
| HT94252510204 | Other Grant/Funding Number | Department of Defense (CDMRP) | |
| 1612632 | Other Identifier | IRBnet | |
| CDMRP-PR241366 | Other Identifier | CDMRP-eBRAP Log number |
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
| Congressionally Directed Medical Research Programs | FED |
| Case Western Reserve University | OTHER |
| University Hospitals Cleveland Medical Center |
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The purpose of this research is to gather information on the safety and effectiveness of an implanted wireless sensory enabled highly intuitive controlled prosthetic device.
The study involves a surgical implant of cuff electrodes on the residual nerves in the amputated limb, and muscle recording electrodes in muscles. These will be connected to an implanted stimulator. The stimulator will connect wirelessly to an advanced prosthesis. This may allow the user to move the prosthetic hand intuitively and feel what the prosthesis is touching.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iSens | Experimental | 3 months trial with the iSens system |
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| State of the Art Prosthesis | No Intervention | 3 months trial with their own prosthesis. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iSens | Device | The study involves a surgical implant of cuff electrodes on the nerves in the amputated limb, and muscle recording electrodes the remaining muscles. These will be connected to an implanted stimulator. The stimulator will connect wirelessly to an advanced prosthesis. This may allow a user to move the prosthetic hand intuitively and feel what your prosthesis is touching. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Experience Measure | Consists of 49 items and consists of five subscales, measuring Self-efficacy, Embodiment, Body image, Prosthesis Efficiency, and Social Touch. Each scale is scored individually, and a higher score indicates a better outcome. | 9 months post implant |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Box and Blocks | Measuring the change in numbers of blocks moved during a timed test. | 9 months post implant |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emily L Graczyk, PhD | Contact | (216) 791-3800 | 63571 | Emily.Graczyk@va.gov |
| Melissa S Schmitt | Contact | (216) 791-3800 | 63801 | Melissa.Schmitt@va.gov |
| Name | Affiliation | Role |
|---|---|---|
| Emily L Graczyk, PhD | Louis Stokes VA Medical Center, Cleveland, OH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Louis Stokes VA Medical Center, Cleveland, OH | Recruiting | Cleveland | Ohio | 44106-1702 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41297066 | Derived | Cady SR, Lambrecht J, Tyler DJ. Enhanced sensory perception and myoelectric control with high channel count implanted sensorimotor systems. J Neural Eng. 2025 Dec 9;22(6):066024. doi: 10.1088/1741-2552/ae24ae. | |
| 40269935 | Derived | Cady SR, Lambrecht JM, Dsouza KT, Dunning JL, Anderson JR, Malone KJ, Chepla KJ, Graczyk EL, Tyler DJ. First-in-human implementation of a bidirectional somatosensory neuroprosthetic system with wireless communication. J Neuroeng Rehabil. 2025 Apr 23;22(1):90. doi: 10.1186/s12984-025-01613-z. |
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Deidentified data will be uploaded to a data repository.
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| OTHER |
| MetroHealth Medical Center | OTHER |
This study is designed as a randomized clinical trial in a small population of subjects to answer the primary question of whether use of a sensory-enabled, high degree-of-freedom (SE-ihDOF) prosthesis with the iSens system improves the subject's quality of life compared to use of their prescribed state-of-art (SOA) prosthesis
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The assessments will be analyzed by a blinded assessor.
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| Case Western Reserve University | Recruiting | Cleveland | Ohio | 44106 | United States |
|
| 38861967 | Derived | Lambrecht JM, Cady SR, Peterson EJ, Dunning JL, Dinsmoor DA, Pape F, Graczyk EL, Tyler DJ. A distributed, high-channel-count, implanted bidirectional system for restoration of somatosensation and myoelectric control. J Neural Eng. 2024 Jun 21;21(3). doi: 10.1088/1741-2552/ad56c9. |