Sensory Feedback for Prosthetics in Amputees
(NISRL Trial)
Trial Summary
What is the purpose of this trial?
Today, prosthetic hands are numb. They provide no tactile or proprioceptive sensory information back to the user. The lack of sensory feedback has been shown to reduce the utility of a prosthesis by half. The prosthesis is seen as a tool, not as an incorporated part of the body schema. Only now are there chronically-implantable technologies which can provide physiologically appropriate sensory feedback to upper limb amputees to recreate tactile and proprioceptive percepts. These sensations are the building blocks to enable the embodiment of the device. Furthermore, newly developed outcome measures are now available which can detail the improved embodiment such neural interfaces can create. The investigator's mission is to enable the embodiment of artificial devices using peripheral nerve stimulation and thereby close the gap between the experience of our intact physiological systems and those using prosthetic remedies. This investigation of embodiment for upper limb amputees is organized into three main areas of work including 1) normative data collection, 2) device development, and 3) characterization of embodiment using peripheral nerve stimulation. The normative data collection will quantify the embodiment of conventional cosmetic, body-powered, and myoelectric prosthetic hand options using a modified Rubber Hand Illusion protocol (Specific Aim 1). This thrust will ask how does the amount of embodiment vary among conventional prosthetic hands as well as probe the relationship between agency and embodiment. The device development project entails the design of multi-modal sensors in order to study full-hand embodiment (Specific Aim 2). The ability to measure and then elicit sensation on the passive surfaces of the hand (palm, ulnar border, and dorsal surface) has never been explored. Here, a multi-modal sensor which can detect proximity, contact, and force will be integrated into a commercially available prosthetic hand in order to provide detailed measurements across the palm, ulnar border, and dorsal surfaces in order to study embodiment in more depth. Finally, the characterization of embodiment using peripheral nerve stimulation will take place over a multiple subject factorial experiment which quantifies the effects of quantity and spatial parameters of the peripheral nerve stimulation on the embodiment of prosthetic hands (Specific Aim 3). This study asks what somatosensory percepts from the hand are most critical for embodiment by varying the parameters of the peripheral nerve stimulation (quantity and spatiality) and measuring the level of embodiment in each case.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment for sensory feedback in prosthetics for amputees?
Research shows that providing sensory feedback to prosthetic limbs helps amputees feel like the prosthesis is part of their body, which can improve their acceptance and use of the prosthetic. Studies have demonstrated that sensory feedback can reduce phantom pain and enhance the feeling of ownership and control over the prosthetic limb.12345
Is sensory feedback for prosthetics safe for human use?
Research on sensory feedback for prosthetics, including invasive methods like implanted nerve interfaces, shows potential benefits but also involves risks. While non-invasive methods are generally safer, invasive techniques have been less explored due to inherent risks, though they have shown some success in restoring sensation.35678
How does the treatment 'Sensory Feedback for Prosthetics in Amputees' differ from other treatments for upper limb amputees?
This treatment is unique because it provides amputees with a sense of touch by connecting pressure sensors on a prosthetic hand to the nerves that once served the lost limb, helping the prosthetic feel like a natural part of the body. Unlike other treatments, it uses targeted reinnervation to create a more integrated and intuitive experience, potentially improving the user's acceptance and control of the prosthetic.3691011
Research Team
Jacob L. Segil, PhD MS
Principal Investigator
Rocky Mountain Regional VA Medical Center, Aurora, CO
Eligibility Criteria
This trial is for both veterans and non-veterans who have an upper limb amputation or are able-bodied. It's not open to individuals with other musculoskeletal injuries.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Normative Data Collection
Quantify the embodiment of conventional prosthetic hand options using a modified Rubber Hand Illusion protocol
Device Development
Design of multi-modal sensors to study full-hand embodiment
Characterization of Embodiment
Quantify the effects of peripheral nerve stimulation on the embodiment of prosthetic hands
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Investigation of Embodiment for Upper Limb Amputees
- Peripheral Nerve Interface
- Prosthetic hand
Find a Clinic Near You
Who Is Running the Clinical Trial?
VA Office of Research and Development
Lead Sponsor