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Peripheral Interfaces in Amputees for Sensorimotor Integration

NCT04430218 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-03-06

No results posted yet for this study

Summary

The purpose of this research is to gather information on the safety and effectiveness of an implanted wireless sensory enabled highly intuitive controlled prosthetic device.

Conditions

  • Upper Extremity Amputee

Interventions

DEVICE

iSens

The study involves a surgical implant of cuff electrodes on the nerves in the amputated limb, and muscle recording electrodes the remaining muscles. These will be connected to an implanted stimulator. The stimulator will connect wirelessly to an advanced prosthesis. This may allow a user to move the prosthetic hand intuitively and feel what your prosthesis is touching.

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Congressionally Directed Medical Research Programs

    collaborator FED

  • Case Western Reserve University

    collaborator OTHER

  • University Hospitals Cleveland Medical Center

    collaborator OTHER

  • MetroHealth Medical Center

    collaborator OTHER

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Emily L Graczyk, PhD · Louis Stokes VA Medical Center, Cleveland, OH

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-18
Primary Completion
2026-06-30
Completion
2032-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04430218 on ClinicalTrials.gov