AmputationNISRLNCT04578327
Investigation of Embodiment for Upper Limb Amputees
A study testing Prosthetic hand and Peripheral Nerve Interface in people with Amputation, run by VA Office of Research and Development at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Amputation
- What is being tested?
- Prosthetic hand and Peripheral Nerve Interface
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jun 2025to 2 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects will be either able bodied or have an upper limb difference.
- Both Veterans and non-Veterans will be eligible.
Who cannot join
- No other musculoskeletal injuries.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, 80045-7211
About this study
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.
Read the 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.
- Conditions
- Amputation
- Being tested
- Prosthetic hand, Peripheral Nerve Interface
- Keywords
- amputation, sensation, neural interface
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prosthetic handDevice
Different types of conventional prosthetic limbs will be used by subjects.
Peripheral Nerve InterfaceProcedure or surgery
Different types of peripheral nerve stimulation will take place
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Procedure: Peripheral Nerve Interface |
What is being measured
The primary outcome is the main question the study is designed to answer.
Southampton Hand Assessment Procedure
Scores the ability of the user to perform activities of daily living using the prosthetic system.
Measured: 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.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start2 Jun 2025
- Primary completion2 Jun 2025
- Study completion2 Jun 2025
Why it stopped: Administratively Closed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputationStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Jacob L. Segil, PhD MS, Principal investigator, Rocky Mountain Regional VA Medical Center, Aurora, CO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04578327
- Sponsor's protocol ID
- A3282-W
- Other IDs
- 1IK2RX003282-01A2
- Acronym
- NISRL
- Status last verified
- Apr 2026
- First submitted
- 6 Jul 2020
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Embodiment for Upper Limb Amputees
- ClinicalTrials.gov ID
- NCT04578327
- Acronym / sponsor ID
- NISRL / A3282-W
- Conditions
- Amputation
- Keywords
- amputation, sensation, neural interface
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Administratively Closed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 2 Jun 2025 (actual)
- Primary completion
- 2 Jun 2025 (actual)
- Study completion
- 2 Jun 2025 (actual)
- First posted
- 8 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Aim 1 | Experimental | Device: Prosthetic handData 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). |
| Aim 3 | Experimental | Procedure: Peripheral Nerve InterfaceData 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects will be either able bodied or have an upper limb difference.
- Both Veterans and non-Veterans will be eligible.
Key exclusion criteria (1 listed)
- No other musculoskeletal injuries.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prosthetic handDifferent types of conventional prosthetic limbs will be used by subjects. | Device | Aim 1 |
| Peripheral Nerve InterfaceDifferent types of peripheral nerve stimulation will take place | Procedure or surgery | Aim 3 |
Primary outcome
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.
Patient Experience Measure
Time frame: Through study completion, an average of 1 year
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacob L. Segil, PhD MS principal investigator
Rocky Mountain Regional VA Medical Center, Aurora, CO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prosthetic hand and Peripheral Nerve Interface in people with Amputation, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Southampton Hand Assessment Procedure (time frame: Through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.