Ignite Creation Date:
2024-05-06 @ 3:16 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04578327
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-10
First Post:
2020-07-06
Brief Title:
Investigation of Embodiment for Upper Limb Amputees
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Investigation of Embodiment for Upper Limb Amputees
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NISRL
Brief Summary:
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 investigators 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
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
Detailed Description:
Leveraging advancements in neural interfaces biomechatronic devices and myoelectric control algorithms my research mission is to enable the embodiment of artificial devices by providing physiologically appropriate somatosensory feedback
Specific Aim 1 How does the amount of embodiment vary among conventional prosthetic hands
Data from Specific Aim 1 will be used to test the following hypotheses H1a The body-powered prosthetic devices are embodied more than passive and myoelectric prosthetic devices H1b Passive cosmetic devices are embodied less than actuated cosmetic devices agency H1c Body-powered terminal devices are embodied less than myoelectric terminal devices agency
Specific Aim 2 Design of Multi-Modal Sensors for Full Hand Sensation No human subject experiments Specific Aim 3 What somatosensory percepts from the hand are most critical for embodiment Data from Specific Aim 3 will be used to test the following hypotheses H3a The maximum number of channels elicits more embodiment than the minimum number H3b The sensory feedback from passive spatial locations of the hand increases the embodiment compared to sensory feedback just from the grasping spatial locations
Specific Aim 1 How does the amount of embodiment vary among conventional prosthetic hands
Data from Specific Aim 1 will be used to test the following hypotheses H1a The body-powered prosthetic devices are embodied more than passive and myoelectric prosthetic devices H1b Passive cosmetic devices are embodied less than actuated cosmetic devices agency H1c Body-powered terminal devices are embodied less than myoelectric terminal devices agency
Specific Aim 2 Design of Multi-Modal Sensors for Full Hand Sensation No human subject experiments Specific Aim 3 What somatosensory percepts from the hand are most critical for embodiment Data from Specific Aim 3 will be used to test the following hypotheses H3a The maximum number of channels elicits more embodiment than the minimum number H3b The sensory feedback from passive spatial locations of the hand increases the embodiment compared to sensory feedback just from the grasping spatial locations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1IK2RX003282-01A2 | NIH | None | httpsreporternihgovquickSearch1IK2RX003282-01A2 |