Using nerve feedback to help lower limb amputees feel sensations in their prosthetics

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of providing sensory feedback to individuals with lower limb amputations through the use of implanted electrodes that stimulate remaining nerves. By delivering small electrical currents to these nerves, the study aims to recreate the sensations of the missing limb, allowing participants to perceive interactions with their prosthetic devices. Additionally, the study explores the use of intramuscular recording electrodes to develop a motor controller for intuitive control of robotic prosthetic legs. Participants will engage in various functional tasks while wearing a sensory neuroprosthesis to assess the effectiveness of the approach.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adults age 18 or greater
* Chronic, medically stable ( \> 3 months) trans-tibial or trans-femoral amputation at the time of implant surgery.
* Potential user of trans-tibial or trans-femoral prostheses for standing or walking
* Viable target nerves in the lower extremity as determined by standard-of-care clinical tests of nerve conduction, response to stimulation, sensory evoked potentials and the like
* Good skin integrity and personal hygiene
* Absence of autoimmune deficiencies, seizure disorders or cardiac abnormalities contraindicating stimulation
* Sufficient social support and personal ability to tolerate study procedures and comply with follow-up schedule

Exclusion Criteria:

* Uncontrolled diabetes to a degree that would preclude surgery
* Significant vascular disease
* Chronic skin ulcerations
* Significant history of poor wound healing
* Significant history of uncontrolled infections
* Active infection
* Significant pain in the residual or phantom limb
* Pregnancy
* Inability to speak English
* Expectation that MRI will be required at any point for the duration of study or while percutaneous leads are in place
* Severe neurological conditions that significantly impair balance or mobility to an extent that independent ambulation is impossible without assistance ( as determined by a healthcare provider)
* Appropriate body habitus (height and weight within acceptable limits as determined by study physician)
* Poor surgical candidate
* Psychiatric or cognitive conditions that could affect cooperation or understanding of instructions and willingness to undergo psychological evaluation, if recommended by study surgeons or investigators.

Where it's running

• Louis Stokes VA Medical Center
  Cleveland, Ohio, United States Recruiting

Study contacts

• Principal investigator: Ronald Triolo, PhD — Louis Stokes VA Medical Center
• Study coordinator: Aarika Sheehan, PT, DPT
• Email: Aarika.Sheehan@va.gov
• Phone: 216-791-3800

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.