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) — DEVICE
    Microelectrode 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

Locations (1)

FacilityCityStateZIPSite coordinators
The University Orthopaedic CenterSalt Lake CityUtah84108
Douglas Hutchinson, M.D.
801-587-5453

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