Recruiting

Observational Study

Sponsor:

VA Office of Research and Development

Code:

NCT04430218

Conditions

Upper Extremity Amputee

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

iSens

Study Details

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.

Conditions

Upper Extremity Amputee

Study ID

NCT04430218

Start date

Aug 18, 2020

Status verified date

Jul, 2026

Completion date

Jun 30, 2032

Anticipated

Primary completion date

Jun 30, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

15 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: iSens

3 months trial with the iSens system

no intervention: State of the Art Prosthesis

3 months trial with their own prosthesis.

Interventions

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.

Primary outcome measure

  • Patient Experience Measure [ Time Frame: 9 months post implant ]

Central Contacts and Locations

Central contacts

Emily L Graczyk, PhD

(216) 791-3800Emily.Graczyk@va.gov

Melissa S Schmitt

(216) 791-3800Melissa.Schmitt@va.gov

Locations

Louis Stokes VA Medical Center, Cleveland, OH

Recruiting

Cleveland, Ohio, United States, 44106-1702

Contacts

Melissa S Schmitt

(216) 791-3800Melissa.Schmitt@va.gov

Jessica R Jarvela, MS BS

(216) 791-3800Jessica.Jarvela@va.gov

Principal Investigator:

Emily L Graczyk, PhD

Case Western Reserve University

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

emily graczyk, PhD

216-368-5182elg46@case.edu

Melissa Schmitt, RN

2167913800mss274@case.edu

More Information

Sponsor

VA Office of Research and Development

Last update posted

Jul 17, 2026

Last verified

Jul, 2026

Keywords

  • Sensory Feedback
  • Advanced Control
  • Sensorimotor feedback
  • Prostheses and implants

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-07-17.