Peripheral Interfaces in Amputees for Sensorimotor Integration
Purpose
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.
Condition
- Upper Extremity Amputee
Eligibility
- Eligible Ages
- Over 21 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Age 21 or greater - Acquired upper limb amputation - Unilateral or bilateral amputation, Above or below elbow - At least 6 months since time of amputation - Current user of a myoelectric prosthesis or prescribed to use one - Viable target nerves in the upper extremity * - Recommendation from a psychologist following a psychological assessment that the subject is mentally competent and capable of completing the study related activities
Exclusion Criteria
- A contraindication preventing surgery - Uncontrolled diabetes - Chronic skin ulcerations - History of poor wound healing without specific cause - History of uncontrolled infection without specific cause - Active infection - Pregnancy or women of childbearing potential unwilling to prevent pregnancy during participation in the study - Inability to speak English - Expectation that MRI will be required at any point for duration of study or while device is implanted. - Arthritis in the area of implant - Individuals with active implantable medical devices or individuals that use external active medical devices that are medically necessary and/or life-supporting or life-sustaining (e.g. insulin pumps, ventilators) - Presence of auto immune diseases, or conditions requiring immunosuppression.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover Assignment
- Intervention Model Description
- 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
- Primary Purpose
- Other
- Masking
- Single (Outcomes Assessor)
- Masking Description
- The assessments will be analyzed by a blinded assessor.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental iSens |
3 months trial with the iSens system |
|
|
No Intervention State of the Art Prosthesis |
3 months trial with their own prosthesis. |
|
Recruiting Locations
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio 44106-1702
Cleveland, Ohio 44106-1702
Case Western Reserve University
Cleveland, Ohio 44106
Cleveland, Ohio 44106
More Details
- NCT ID
- NCT04430218
- Status
- Recruiting
- Sponsor
- VA Office of Research and Development
Detailed Description
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.