Can an Array of Micro-electrodes Implanted in a Human Nerve Record Neural Signals and Provide Feedback?

ConditionAmputation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Utah

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

incarceration

pregnancy

inability to consent

psychiatric comorbidity

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

3 Participants
are divided into 1 treatment group
Group A: Implantation of a percutaneous Utah Slanted Electrode Arrays (pUSEAs)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Measure Action Potentials (millivolts, mV)

Three participants after receiving a stimuli will have action potentials (millivolts, mV) arising from the axons surrounding the tip of each electrode recorded in time. The moving action potentials (mV) measure five phases: resting potential, depolarization, peak, repolarization, and hyperpolarization.

Time frame
Up to 2-years Follow-up

Secondary outcomes

Other outcomes

Sponsors and contacts

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