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NCT Number: NCT04430218

Peripheral Interfaces in Amputees for Sensorimotor Integration

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.

Recruiting

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Case Western Reserve University, Cleveland, Ohio, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Treatment and study plan

iSens

Device

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.

Primary outcomes

  1. 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 outcomes

  1. Modified Box and Blocks

    Time frame: 9 months post implant

    Measuring the change in numbers of blocks moved during a timed test.

Study contacts

Contact information is provided by the study sponsor or research team.

Emily L Graczyk, PhD

CONTACT

[email protected]

(216) 791-3800 ext. 63571

Melissa S Schmitt

CONTACT

[email protected]

(216) 791-3800 ext. 63801

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Collaborators

  • Case Western Reserve University
  • Congressionally Directed Medical Research Programs
  • MetroHealth Medical Center
  • United States Department of Defense
  • University Hospitals Cleveland Medical Center

Registry information

Acronym: iSens

Important dates

Study start
2020
Primary completion
2032
Study completion
2032
First posted
Jun 12, 2020
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.