Can an Array of Micro-electrodes Implanted in a Human Nerve Record Neural Signals and Provide Feedback?
Part of paid clinical trials in Salt Lake City, Utah.
- Sponsor
- University of Utah
- Study ID
- NCT05505513
- Status
- Recruiting
Conditions
- Amputation
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Not accepted
Interventions
- percutaneous Utah Slanted Electrode Arrays (pUSEAs) — DEVICEMicroelectrode slanted arrays with a large number of electrodes will be surgically implanted into peripheral nerves of patients with limb amputations.
Study Details
The investigators will investigate the device feasibility of human peripheral nerves and muscles recording and stimulation using percutaneous Utah Slanted Electrode Arrays (pUSEAs) implanted into residual peripheral arm nerves and EMG electrodes implanted in the residual muscles of patients with limb amputations in order to determine the ability of the HAPTIX (Hand Proprioception and Touch Interfaces) System to control an upper-extremity prosthesis, and to provide a sense of cutaneous touch and muscle proprioceptive feedback to the amputee.
Key Dates
- Start date
- Dec 21, 2020
- Status verified
- May 2026
- Primary completion
- Dec 31, 2028
- Completion
- Dec 31, 2028
Study Design
- Enrollment
- 3 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- DEVICE_FEASIBILITY
Arms
- Experimental: Implantation of a percutaneous Utah Slanted Electrode Arrays (pUSEAs)The arm (s) of the patient which has been amputated. Intervention include insertion of the percutaneous Utah Slanted Electrode Arrays which will interact with nerve endings in order to gain knowledge about device feasibility and nerve stimulation.
Primary Outcome Measure
Measure Action Potentials (millivolts, mV) [ Time Frame: Up to 2-years Follow-up ]
Central Contacts
- Douglas Hutchinson, M.D.801-587-5400
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| The University Orthopaedic Center | Salt Lake City | Utah | 84108 | Douglas Hutchinson, M.D. 801-587-5453 |
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