Investigation of Embodiment for Upper Limb Amputees

NCT04578327 | Withdrawn FDA Device

• 2 other identifiers: A3282-W1IK2RX003282-01A2
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Amputation

Keywords

amputation; sensation; neural interface

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Aim 1

EXPERIMENTAL

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).

Device: Prosthetic hand

Aim 3

EXPERIMENTAL

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.

Procedure: Peripheral Nerve Interface

Interventions

Prosthetic hand DEVICE

Different types of conventional prosthetic limbs will be used by subjects.

Aim 1

Peripheral Nerve Interface PROCEDURE

Different types of peripheral nerve stimulation will take place

Aim 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects will be either able bodied or have an upper limb difference.
• Both Veterans and non-Veterans will be eligible.

You may not qualify if:

• No other musculoskeletal injuries.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Rocky Mountain Regional VA Medical Center, Aurora, CO

Aurora, Colorado, 80045-7211, United States

Location

Study Officials

• Jacob L. Segil, PhD MS

  Rocky Mountain Regional VA Medical Center, Aurora, CO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Aim 1 - An experiment will take place grouped by the type of prosthesis used by upper limb amputees Aim 3 - An experiment will take place grouped by type of sensory restoration

Study Record Dates

• First Submitted: July 6, 2020
• First Posted: October 8, 2020
• Study Start: June 2, 2025
• Primary Completion: June 2, 2025
• Study Completion: June 2, 2025
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)