Trial reportJournal of neuroengineering and rehabilitation2025
First-in-human implementation of a bidirectional somatosensory neuroprosthetic system with wireless communication.
Trial report in Journal of neuroengineering and rehabilitation, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04430218 (Peripheral Interfaces in Amputees for Sensorimotor Integration), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Peripheral Interfaces in Amputees for Sensorimotor Integration
Who cites it
5 citing papers in PubMed, 1 synthesis or guideline pooled it.
- A Systematic Review on Haptic Feedback in Medical Robotics: Technologies, Applications, Clinical Translation, and an Information-Oriented Perspective.Sensors (Basel, Switzerland) · 2026Pooled it
- Neural Interfaces for Bidirectional Sensory Restoration in Limb Prostheses: Current Evidence and Clinical Translation.Journal of clinical medicine · 2026Review
- Effective Interventions in Restoring Mobility and Relieving Pain After Lower Limb Amputation.Journal of orthopaedics and sports medicine · 2026Article
- Decoding Overlapping Lower-Limb Afferent Pathways from Human Epidural Spinal Recordings.Research square · 2026Article
- Enhanced sensory perception and myoelectric control with high channel count implanted sensorimotor systems.Journal of neural engineering · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
Abstract
backgroundLimitations in upper limb prosthesis function and lack of sensory feedback are major contributors to high prosthesis abandonment rates. Peripheral nerve stimulation and intramuscular recording can restore touch and relay motor intentions for individuals with upper limb loss. Percutaneous systems have enabled significant progress in implanted neural interfaces but require chronic lead maintenance and unwieldy external equipment. Fully implanted sensorimotor systems without percutaneous leads are crucial for advancing implanted neuroprosthetic technologies to long-term community use and commercialization.
methodsWe present the first-in-human technical performance of the implanted Somatosensory Electrical Neurostimulation and Sensing (iSens®) system-an implanted, high-channel count myoelectric sensing and nerve stimulation system that uses wireless communication for advanced prosthetic systems. Two individuals with unilateral transradial amputations received iSens® with four 16-channel composite Flat Interface Nerve Electrodes (C-FINEs) and four Tetra Intramuscular (TIM) electrodes. This study achieved two key objectives to demonstrate system feasibility prior to long-term community use: (1) evaluating the chronic stability of extraneural cuff electrodes, intramuscular electrodes, and active implantable devices in a wirelessly connected system and (2) assessing the impacts of peripheral nerve stimulation on three degree-of-freedom controller performance in a wirelessly connected system to validate iSens® as a bidirectional interface.
resultsSimilar to prior percutaneous systems, we demonstrate chronically stable extraneural cuff electrodes and intramuscular electrodes in a wirelessly connected implanted system for more than two years in one participant and four months in the second participant, whose iSens® system was explanted due to an infection of unknown origin. Using an artificial neural network controller trained on implanted electromyographic data collected during known hand movements, one participant commanded a virtual hand and sensorized prosthesis in 3 degrees-of-freedom. The iSens® system simultaneously produced stimulation for sensation while recording high resolution muscle activity for real-time control. Although restored sensation did not significantly improve initial trials of prosthetic controller performance, the participant reported that sensation was helpful for functional tasks.
conclusionsThis case series describes a wirelessly connected, bidirectional neuroprosthetic system with somatosensory feedback and advanced myoelectric prosthetic control that is ready for implementation in long-term home use clinical trials.
trial registrationClinicalTrials.gov ID: NCT04430218, 2020-06-30.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.