Implanting a wireless sensory device in amputees for better control of prosthetics
Peripheral Interfaces in Amputees for Sensorimotor Integration
This study is testing a new wireless device that helps people with arm amputations control their prosthetic hands better and feel sensations from them.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 2 sites (Cleveland, Ohio and 1 other locations) |
| Trial ID | NCT04430218 on ClinicalTrials.gov |
What this trial studies
This research focuses on the safety and effectiveness of an implanted wireless sensory-enabled prosthetic device for upper extremity amputees. The study involves surgically implanting cuff electrodes on residual nerves and muscle recording electrodes, which connect to an implanted stimulator. This stimulator wirelessly interfaces with an advanced prosthesis, potentially allowing users to intuitively control the prosthetic hand and receive sensory feedback from it. The goal is to enhance the user's experience and functionality with their prosthetic limb.
Who should consider this trial
Good fit: Ideal candidates include adults aged 21 or older with unilateral or bilateral upper limb amputations who are current users of myoelectric prostheses.
Not a fit: Patients with contraindications for surgery, uncontrolled diabetes, or those who cannot communicate in English may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life for amputees by providing intuitive control and sensory feedback from their prosthetic devices.
How similar studies have performed: Other studies have shown promise with similar sensory feedback approaches in prosthetics, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Cleveland, Ohio and 1 other locations
- Louis Stokes VA Medical Center, Cleveland, OH — Cleveland, Ohio, United States (Recruiting)
- Case Western Reserve University — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Emily L Graczyk, PhD — Louis Stokes VA Medical Center, Cleveland, OH
- Study coordinator: Emily L Graczyk, PhD
- Email: Emily.Graczyk@va.gov
- Phone: (216) 791-3800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.