Peripheral Interfaces in Amputees for Sensorimotor Integration (iSens)

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 Overview

• Status: Recruiting
• Conditions: Upper Extremity Amputee
• Intervention / Treatment: Device: iSens

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.

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dustin J Tyler, PhD; Phone Number: (216) 791-3800; Email: dustin.tyler@va.gov
• Study Contact Backup: Name: Melissa S Schmitt; Phone Number: 63801 (216) 791-3800; Email: Melissa.Schmitt@va.gov

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106-1702
      • Recruiting
      • Louis Stokes VA Medical Center, Cleveland, OH
      • Principal Investigator: Dustin J. Tyler, PhD
      • Contact: Holly B Henry; Phone Number: 64657 216-791-3800; Email: holly.henry@va.gov
      • Contact: Neal S Peachey, PhD; Phone Number: (216) 421-3221; Email: neal.peachey@va.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: iSens; 3 months trial with the iSens system	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.
No Intervention: State of the Art Prosthesis; 3 months trial with their own prosthesis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Experience Measure	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.	9 months post implant

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Collaborators: Defense Advanced Research Projects Agency
• Investigators: Principal Investigator: Dustin J. Tyler, PhD, Louis Stokes VA Medical Center, Cleveland, OH

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2020
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2032

Study Registration Dates

• First Submitted: May 12, 2020
• First Submitted That Met QC Criteria: June 11, 2020
• First Posted (Actual): June 12, 2020

Study Record Updates

• Last Update Posted (Actual): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Sensory Feedback; Advanced Control; Sensorimotor feedback; Prostheses and implants
• Other Study ID Numbers: A3355-R; RX003355-01 (Other Grant/Funding Number: VA RR&D)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Deidentified data will be uploaded to a data repository.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes