Actively Recruiting
Short-term Implanted Electrodes Following Regenerative Peripheral Nerve Surgery for Improving Prosthetic Limb Control Signals
Led by University of Michigan · Updated on 2025-08-26
10
Participants Needed
1
Research Sites
594 weeks
Total Duration
On this page
Sponsors
U
University of Michigan
Lead Sponsor
N
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
The device, a bipolar percutaneous intramuscular electromyography electrode, is intended for use in upper-limb amputation patients who have received the regenerative peripheral nerve interface surgical procedure, in order to enable the use of advanced prosthetic arms and hands.
CONDITIONS
Official Title
Short-term Implanted Electrodes Following Regenerative Peripheral Nerve Surgery for Improving Prosthetic Limb Control Signals
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be 22 years of age or older.
- Participants must have previously undergone an upper limb amputation proximal to the wrist.
- For participants without existing RPNI grafts, the residual limb must have enough healthy soft tissue for the RPNI surgery.
- Participants must be in good health with low surgical risk (ASA Class I or II).
- Participants must have reliable transportation.
- Participants must be able to attend at least two visits per month while electrodes are implanted.
- Participants must be at least 6 months post-amputation.
You will not qualify if you...
- Participants with severe pain syndromes like complex regional pain syndrome or severe phantom pain are excluded.
- Participants with untreated mental health disorders or without approval from a mental health professional if diagnosed are excluded.
- Participants with medical conditions posing high surgical risk (such as recent heart attack, stroke, blood clots, uncontrolled diabetes, or end stage renal disease) are excluded.
- Tobacco use within one month before enrollment or during the study is not allowed.
- Participants with bilateral upper extremity amputation are excluded.
- Pregnant participants are excluded.
- Participants with other implanted electronic devices like pacemakers or neurostimulators are excluded.
- Participants with severe peripheral vascular disease, venous hypertension, or severe lymphedema in the limb are excluded.
- Participants with poorly controlled autoimmune conditions are excluded.
- Participants whose amputation is due to traumatic injury or cancer are not considered for enrollment.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
Research Team
P
Paul Cederna, M.D.
CONTACT
J
Jenni Hamill, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
2
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