Peripheral Interfaces in Amputees for Sensorimotor Integration

Description

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

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Study Overview

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Study Details

Study overview

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.

Peripheral Interfaces in Amputees for Sensorimotor Integration

Peripheral Interfaces in Amputees for Sensorimotor Integration

Condition
Upper Extremity Amputee
Intervention / Treatment

-

Contacts and Locations

Cleveland

Louis Stokes VA Medical Center, Cleveland, OH, Cleveland, Ohio, United States, 44106-1702

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Age 21 or greater
  • * Acquired upper limb amputation
  • * Unilateral or bilateral amputation, Above or below 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 following a psychological assessment that the subject is mentally competent and capable of completing the study related activities
  • * A 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 participation in the study
  • * Inability to speak English
  • * Expectation that MRI will be required at any point for duration of study or while device is implanted.
  • * Arthritis in the area of implant
  • * Individuals with active implantable medical devices or individuals that use external active medical devices that are medically necessary and/or life-supporting or life-sustaining (e.g. insulin pumps, ventilators)
  • * Presence of auto immune diseases, or conditions requiring immunosuppression.

Ages Eligible for Study

21 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

VA Office of Research and Development,

Dustin J. Tyler, PhD, PRINCIPAL_INVESTIGATOR, Louis Stokes VA Medical Center, Cleveland, OH

Study Record Dates

2032-06-30