Peripheral Interfaces in Amputees for Sensorimotor Integration

Not Applicable

Recruiting

• Conditions: Upper Extremity Amputee
• Interventions: Device: iSens

• Registration Number: NCT04430218
• Lead Sponsor: VA Office of Research and Development

Brief Summary

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.

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 Timeline

• Study First Submitted: 2020-05-12
• Study First Submitted QC: 2020-06-11
• Study First Posted: 2020-06-12
• Study Start: 2020-08-18
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-02
• Primary Completion: 2026-06-30
• Study Completion: 2032-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
iSens	iSens	3 months trial with the iSens system

Primary Outcome Measures

Name	Time	Method
Patient Experience Measure	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 Outcome Measures

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

Trial Locations

Locations (1)

Louis Stokes VA Medical Center, Cleveland, OH; 🇺🇸 Cleveland, Ohio, United States