- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04578327
Investigation of Embodiment for Upper Limb Amputees (NISRL)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jacob L Segil, PhD MS
- Phone Number: (303) 399-8020
- Email: jacob.segil@colorado.edu
Study Locations
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Colorado
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Aurora, Colorado, United States, 80045
- Rocky Mountain Regional VA Medical Center, Aurora, CO
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Contact:
- Jacob L Segil, PhD MS
- Phone Number: 303-399-8020
- Email: jacob.segil@colorado.edu
-
Contact:
- Laurie P Grevious
- Phone Number: (720) 857-5107
- Email: Laurie.Grevious@va.gov
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Principal Investigator:
- Jacob L. Segil, PhD MS
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Aim 1
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).
|
Different types of conventional prosthetic limbs will be used by subjects.
|
Experimental: Aim 3
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.
|
Different types of peripheral nerve stimulation will take place
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Southampton Hand Assessment Procedure
Time Frame: Through study completion, an average of 1 year
|
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
Time Frame: Through study completion, an average of 1 year
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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
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jacob L. Segil, PhD MS, Rocky Mountain Regional VA Medical Center, Aurora, CO
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- A3282-W
- 1IK2RX003282-01A2 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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