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 volunteersQualifiers
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
Single group
Treatments tested in this trial
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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Sponsors and contacts
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