Peripheral Interfaces in Amputees for Sensorimotor Integration

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Other
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: June 30, 2024

Detailed Description

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

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.

Arms, Groups and Cohorts

  • Experimental: iSens
    • 3 months trial with the iSens system
  • No Intervention: State of the Art Prosthesis
    • 3 months trial with their own prosthesis.

Clinical Trial Outcome Measures

Primary Measures

  • Patient Experience Measure
    • Time Frame: 9 months post implant
    • Consists of 49 items and consists of five subscales, measuring Self-efficacy, Embodiment, Body image, Prosthesis Efficiency, and Social Touch. Each scale is scored individually, and a higher score indicates a better outcome.

Secondary Measures

  • Modified Box and Blocks
    • Time Frame: 9 months post implant
    • Measuring the change in numbers of blocks moved during a timed test.

Participating in This Clinical Trial

Inclusion 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 Exclusion Criteria:

  • 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.

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • VA Office of Research and Development
  • Collaborator
    • Defense Advanced Research Projects Agency
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Dustin J. Tyler, PhD, Principal Investigator, Louis Stokes VA Medical Center, Cleveland, OH
  • Overall Contact(s)
    • Dustin J Tyler, PhD, (216) 791-3800, dustin.tyler@va.gov

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