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NCT06275282 · ClinicalTrials.gov registry record · NA
Regenerative Peripheral Nerve Interface for Control of Lower Limb Prostheses
A NA study of Amputation and Prostheses and Implants, sponsored by University of Michigan.
- Recruiting
- Registry status
- NA
- Development phase
- 3
- Enrollment target
- 1
- Study location
NCT06275282 is a NA study of Amputation and Prostheses and Implants that is actively recruiting participants, run by University of Michigan. The registered enrollment target is 3 participants, below the 133-participant average among 65 other Amputation trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06275282, a NA study of Amputation and Prostheses and Implants, is actively recruiting participants, sponsored by University of Michigan.
- RECRUITING
- Registry status
- NA
- Development phase
- 3 participants
- Enrollment target
- 1
- Study location
Study Summary
Individuals with an above-knee lower limb amputation are known to walk more slowly, expend more energy, have a greater risk of falling, and have reduced quality of life compared to individuals without amputation and those with below knee amputation. One of the driving factors behind these deficits is the lack of active function provided by above-knee prostheses with prosthetic knees and ankles. While many prosthetic devices have been developed for functional restoration after major lower extremity amputation, there remains no stable interface to facilitate reliable, long-term volitional control of an advanced robotic limb capable moving multiple joints. Moreover, there is no existing interface that provides useful sensory feedback that in turn enhances the functional capabilities of the prosthesis. To achieve both greater signal specificity and long-term signal stability, we have developed a biologic interface known as the Regenerative Peripheral Nerve Interface (RPNI). An RPNI consists of a peripheral nerve that is implanted into a free muscle graft that would otherwise go unused in the residual limb. As the nerve grows, it reinnervates the free muscle graft which undergoes a predictable sequence of revascularization and regeneration. The main questions it aims to answer are: 1. Can the amplitude, movement specificity and stability of sciatic nerve RPNI electromyography (EMG) signals be detected up to one year post RPNI surgery? 2. Do RPNIs contain information to enable control of a physical motorized prosthetic leg with multiple degrees of freedom? 3. Does stimulation of sciatic nerve RPNIs provides meaningful sensory feedback? Consenting participants with unilateral transfemoral amputation (TFA) will: 1. Undergo RPNI surgery and electrode implantation in the residual limb. 2. Attend regular follow-up visits following surgery to assess the health and signal strength of the RPNIs and their ability to use a prescribed prosthesis between 3- and 12-months followin
Conditions Studied
Interventions
- DEVICE Intramuscular electrodes
Study Locations (1)
Michigan
- University of Michigan - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2025-02-13 |
| Est. Completion | 2027-09-30 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06275282
The ClinicalTrials.gov registry entry for NCT06275282 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 133-participant average among 65 other Amputation trials with a reported enrollment target (98% lower). The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Amputation appearing as the primary indexed condition, and to 1 intervention - of which Intramuscular electrodes is the first listed.
NCT06275282 reports 1 study location spanning 1 distinct geographic area - top geographies include Michigan.
Frequently Asked Questions
What is clinical trial NCT06275282 about?
NCT06275282 is a clinical study titled "Regenerative Peripheral Nerve Interface for Control of Lower Limb Prostheses". Individuals with an above-knee lower limb amputation are known to walk more slowly, expend more energy, have a greater risk of falling, and have reduced quality of life compared to individuals without amputation and those with below knee amputation. One of the driving factors behind these deficits i...
What is the current status of trial NCT06275282?
This trial is currently recruiting. It is a NA study. The enrollment target is 3 participants. The study started on 2025-02-13. Estimated completion is 2027-09-30.
What conditions does trial NCT06275282 study?
This clinical trial studies the following conditions: Amputation, Prostheses and Implants.
What interventions are being tested in trial NCT06275282?
The interventions under investigation include: Intramuscular electrodes (DEVICE).
Who is sponsoring clinical trial NCT06275282?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06275282 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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