Using micro-electrodes to control prosthetic limbs and provide sensory feedback for amputees
Can an Array of Micro-electrodes Implanted in a Human Nerve Record Neural Signals and Provide Sensory Feedback Useful for Controlling a Prosthetic Device?
This study is testing if tiny electrodes can help amputees control advanced prosthetic arms and feel sensations like touch.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 3 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Utah Academic / other |
| Locations | 1 site (Salt Lake City, Utah) |
| Trial ID | NCT05505513 on ClinicalTrials.gov |
What this trial studies
This study investigates the feasibility of using percutaneous Utah Slanted Electrode Arrays (pUSEAs) implanted in the peripheral nerves and EMG electrodes in the muscles of patients with upper-limb amputations. The goal is to assess whether these microelectrodes can effectively record neural signals and provide sensory feedback to control advanced prosthetic devices like the DEKA LUKE arm. The study will evaluate the ability of the HAPTIX System to enhance the functionality of prosthetic limbs, allowing for more natural movements and sensations of touch and proprioception. This early feasibility study aims to improve the quality of life for amputees by enabling better control over their prosthetic devices.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 65 with unilateral or bilateral traumatic or elective upper extremity amputations at the transradial level.
Not a fit: Patients who are incarcerated, pregnant, unable to consent, or have psychiatric comorbidities or medical conditions that increase anesthesia risks may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance the control and sensory experience of prosthetic limbs for amputees.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in using neural interfaces for prosthetic control, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * at least 18 years of age and less than 65 years of age * unilateral and bilateral traumatic or elective upper extremity amputations at the transradial level Exclusion Criteria: * incarceration * pregnancy * inability to consent * psychiatric comorbidity * medical conditions that significantly increase the risk of adverse effects of general anesthesia
Where this trial is running
Salt Lake City, Utah
- The University Orthopaedic Center — Salt Lake City, Utah, United States (Recruiting)
Study contacts
- Principal investigator: Douglas Hutchinson, M.D. — University of Utah Orthopaedics
- Study coordinator: Douglas Hutchinson, M.D.
- Email: Douglas.Hutchinson@hsc.utah.edu
- Phone: 801-587-5400
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.