Recruiting

Neural Feedback

Sponsor:

University of Utah

Code:

NCT05505513

Conditions

Amputation

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

percutaneous Utah Slanted Electrode Arrays (pUSEAs)

Study Details

Brief summary:

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.

Conditions

Amputation

Study ID

NCT05505513

Start date

Dec 21, 2020

Status verified date

May, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

3 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

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.

Interventions

percutaneous Utah Slanted Electrode Arrays (pUSEAs)

Microelectrode slanted arrays with a large number of electrodes will be surgically implanted into peripheral nerves of patients with limb amputations.

Primary outcome measure

  • Measure Action Potentials (millivolts, mV) [ Time Frame: Up to 2-years Follow-up ]

Central Contacts and Locations

Central contacts

Douglas Hutchinson, M.D.

801-587-5400Douglas.Hutchinson@hsc.utah.edu

Locations

The University Orthopaedic Center

Recruiting

Salt Lake City, Utah, United States, 84108

Contacts

Douglas Hutchinson, M.D.

801-587-5453

More Information

Sponsor

University of Utah

Last update posted

May 13, 2026

Last verified

May, 2026

Keywords

  • Micro-Electrodes
  • Amputation
  • Prosthetic Device

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Utah on 2026-05-13.