Actively Recruiting

Phase Not Applicable
Age: 21Years +
All Genders
NCT04430218

Peripheral Interfaces in Amputees for Sensorimotor Integration

Led by VA Office of Research and Development · Updated on 2026-03-06

15

Participants Needed

2

Research Sites

619 weeks

Total Duration

On this page

Sponsors

V

VA Office of Research and Development

Lead Sponsor

U

United States Department of Defense

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Peripheral Interfaces in Amputees for Sensorimotor Integration

Who Can Participate

Age: 21Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 21 or greater
  • Acquired upper limb amputation
  • Unilateral or bilateral amputation, above or below the elbow
  • At least 6 months since time of amputation
  • Current user of a myoelectric prosthesis or prescribed to use one
  • Viable target nerves in the upper extremity
  • Recommendation from a psychologist confirming mental competence and ability to complete study activities
Not Eligible

You will not qualify if you...

  • Contraindication preventing surgery
  • Uncontrolled diabetes
  • Chronic skin ulcerations
  • History of poor wound healing without specific cause
  • History of uncontrolled infection without specific cause
  • Active infection
  • Pregnancy or women of childbearing potential unwilling to prevent pregnancy during the study
  • Inability to speak English
  • Expectation of needing an MRI during the study or while device is implanted
  • Arthritis in the implant area
  • Use of active implantable medical devices or necessary life-supporting external devices
  • Presence of autoimmune diseases or conditions requiring immunosuppression

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, United States, 44106-1702

Actively Recruiting

2

Case Western Reserve University

Cleveland, Ohio, United States, 44106

Actively Recruiting

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Research Team

E

Emily L Graczyk, PhD

CONTACT

M

Melissa S Schmitt

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

OTHER

Number of Arms

2

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