Peripheral Interfaces in Amputees for Sensorimotor Integration
iSens
5 other identifiers
interventional
15
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2020
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 12, 2020
CompletedFirst Posted
Study publicly available on registry
June 12, 2020
CompletedStudy Start
First participant enrolled
August 18, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2032
March 6, 2026
March 1, 2026
5.9 years
May 12, 2020
March 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Modified Box and Blocks
9 months post implant
Study Arms (2)
iSens
EXPERIMENTAL3 months trial with the iSens system
State of the Art Prosthesis
NO INTERVENTION3 months trial with their own prosthesis.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- VA Office of Research and Developmentlead
- United States Department of Defensecollaborator
- Congressionally Directed Medical Research Programscollaborator
- Case Western Reserve Universitycollaborator
- University Hospitals Cleveland Medical Centercollaborator
- MetroHealth Medical Centercollaborator
Study Sites (2)
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, 44106-1702, United States
Case Western Reserve University
Cleveland, Ohio, 44106, United States
Related Publications (3)
Cady SR, Lambrecht J, Tyler DJ. Enhanced sensory perception and myoelectric control with high channel count implanted sensorimotor systems. J Neural Eng. 2025 Dec 9;22(6):066024. doi: 10.1088/1741-2552/ae24ae.
PMID: 41297066DERIVEDCady SR, Lambrecht JM, Dsouza KT, Dunning JL, Anderson JR, Malone KJ, Chepla KJ, Graczyk EL, Tyler DJ. First-in-human implementation of a bidirectional somatosensory neuroprosthetic system with wireless communication. J Neuroeng Rehabil. 2025 Apr 23;22(1):90. doi: 10.1186/s12984-025-01613-z.
PMID: 40269935DERIVEDLambrecht JM, Cady SR, Peterson EJ, Dunning JL, Dinsmoor DA, Pape F, Graczyk EL, Tyler DJ. A distributed, high-channel-count, implanted bidirectional system for restoration of somatosensation and myoelectric control. J Neural Eng. 2024 Jun 21;21(3). doi: 10.1088/1741-2552/ad56c9.
PMID: 38861967DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Emily L Graczyk, PhD
Louis Stokes VA Medical Center, Cleveland, OH
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The assessments will be analyzed by a blinded assessor.
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2020
First Posted
June 12, 2020
Study Start
August 18, 2020
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2032
Last Updated
March 6, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share
Deidentified data will be uploaded to a data repository.