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Recruiting NCT04430218

Peripheral Interfaces in Amputees for Sensorimotor Integration

No phase Interventional Upper Extremity Amputee

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: iSens.
Who it may be relevant to
Registry conditions: Upper Extremity Amputee. Basic parameters: from 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Patient Experience Measure [Time frame: 9 months post implant]
Secondary outcome measures (1)
  • Modified Box and Blocks [Time frame: 9 months post implant]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Other

Study locations

United States · 2 centers
  • Louis Stokes VA Medical Center, Cleveland, OH — Cleveland
  • Case Western Reserve University — Cleveland

Publications

  • 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 41297066
  • Cady 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 40269935
  • Lambrecht 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 38861967

Identifiers

NCT: NCT04430218 · A3355-R · RX003355-01 · HT94252510204 · 1612632 · CDMRP-PR241366

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗