Feasibility of Neural Feedback for Lower Limb Amputees
This study is exploring a new way to provide sensation to people who have lost a lower limb, either above or below the knee. It uses stimulating nerve electrodes, which are small devices surgically placed on your remaining nerves. These electrodes deliver tiny electrical currents that aim to create feelings in your missing limb, similar to how your brain used to receive information from your foot and lower leg. The study will measure how much electrical stimulation is needed to create these sensations (Stimulation Thresholds) and how well you can walk and move (Functional Gait Assessment) after the electrodes are implanted. You might also have the option to have recording electrodes placed in your muscles to help develop a robotic prosthetic leg that you can control more intuitively. Adults aged 18 or older with stable amputations and viable nerves are eligible to participate. The current status of the study is unclear, and it plans to enroll 15 participants.
- Study design
- This is an interventional study with a planned enrollment of 15 participants. It is not specified if it is randomized or blinded.
- What's involved
- Electrodes will be surgically implanted on one to four nerves. You will describe perceived sensations and wear an instrumented prosthesis for various functional tasks. You may also have recording electrodes implanted in your muscles.
- Compensation
- Not stated in the trial record.
- Follow-up
- Stimulation thresholds will be measured at 9 months post-implant, and functional gait assessment will be measured at 1 year post-implant.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Feasibility of Neural Feedback for Lower Limb Amputees
At a glance
Conditions
NCT03409133
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Louis Stokes VA Medical Center
Cleveland, Ohiostudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Ronald Triolo, PhD · PRINCIPAL_INVESTIGATOR · Louis Stokes VA Medical Center
Who to contact
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Inclusion
Exclusion
What this trial measures
- Stimulation Thresholds9 months post implant
Quantify the minimum stimulation required to evoke electrically induced sensations on the phantom limb.
- Functional Gait Assessment (FGA)1 year post implant
The Functional Gait Assessment is a 10 task test that measures postural stability. Each task is scored from 0 -3 with 0 indicating severe impairment in the task and 3 indicating normal ambulation. The scores are combined to give a total score. The maximum score is 30. A higher score indicates a better outcome.