What this study is
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.
What's being tested
- iSens
Intervention · 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.
Study details
- Sponsor
- VA Office of Research and Development
- Conditions
- Upper Extremity Amputee
- Enrolling
- 15 people
- Starts
- 2020-08-18
- Est. completion
- 2032-06-30
- Design
- Single-blind, randomized, crossover
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 21 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openLouis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, United States
- Melissa S Schmitt · Contact(216) 791-3800 ext. 63801Melissa.Schmitt@va.gov
- Jessica R Jarvela, MS BS · Contact(216) 791-3800 ext. 63801Jessica.Jarvela@va.gov
- Dustin J. Tyler, PhD · Sub-investigator
- Emily L Graczyk, PhD · Principal investigator
RecruitingCase Western Reserve University
Cleveland, Ohio, United States
- emily graczyk, PhD · Contact216-368-5182elg46@case.edu
- Melissa Schmitt, RN · Contact2167913800 ext. 63801mss274@case.edu
Recruiting
Study team
Sponsor
VA Office of Research and Development
Study ID A3355-R
Principal investigator
Emily L Graczyk, PhD
Louis Stokes VA Medical Center, Cleveland, OH
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.