Investigation of Embodiment for Upper Limb Amputees

Amputation Clinical Trial

— NISRL  

Official title:

Investigation of Embodiment for Upper Limb Amputees

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04578327
• Other study ID #: A3282-W
• Secondary ID: 1IK2RX003282-01A
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2, 2025
• Est. completion date: December 31, 2026

Study information

• Verified date: October 2023
• Source: VA Office of Research and Development
• Contact: Jacob L Segil, PhD MS
• Phone: (303) 399-8020
• Email: jacob.segil[@]colorado.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 19
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects will be either able bodied or have an upper limb difference.

• Both Veterans and non-Veterans will be eligible.

Exclusion Criteria:

• No other musculoskeletal injuries.

Related Conditions & MeSH terms

• Amputation

Intervention

Device:
• Prosthetic hand
Different types of conventional prosthetic limbs will be used by subjects.

Procedure:
• Peripheral Nerve Interface
Different types of peripheral nerve stimulation will take place

Locations

Country	Name	City	State
United States	Rocky Mountain Regional VA Medical Center, Aurora, CO	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Southampton Hand Assessment Procedure	Scores the ability of the user to perform activities of daily living using the prosthetic system.	Through study completion, an average of 1 year
Primary	Patient Experience Measure	Assesses the subject's perspective on the embodiment of the prosthetic system. The Patient Experience Measure (PEM) is a validated outcome measure which uses a survey to identify the experience of the person with amputation. The qualitative and quantitative survey produces outcome measures identifying the patient experience across multiple modalities.	Through study completion, an average of 1 year