Peripheral Interfaces in Amputees for Sensorimotor Integration
Part of paid clinical trials in Cleveland, Ohio.
- Sponsor
- VA Office of Research and Development
- Study ID
- NCT04430218
- Status
- Recruiting
Conditions
- Upper Extremity Amputee
Eligibility Criteria
- Sex
- ALL
- Age
- 21 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- iSens — DEVICEThe 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.
Study Details
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.
Key Dates
- Start date
- Aug 18, 2020
- Status verified
- Mar 2026
- Primary completion
- Jun 30, 2026
- Completion
- Jun 30, 2032
Study Design
- Enrollment
- 15 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- OTHER
Arms
- Experimental: iSens3 months trial with the iSens system
- No Intervention: State of the Art Prosthesis3 months trial with their own prosthesis.
Primary Outcome Measure
Patient Experience Measure [ Time Frame: 9 months post implant ]
Central Contacts
- Emily L Graczyk, PhD(216) 791-3800
- Melissa S Schmitt(216) 791-3800
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Case Western Reserve University | Cleveland | Ohio | 44106 | |
| Louis Stokes VA Medical Center, Cleveland, OH | Cleveland | Ohio | 44106-1702 | Dustin J. Tyler, PhD (SUB_INVESTIGATOR) Emily L Graczyk, PhD (PRINCIPAL_INVESTIGATOR) |