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Upper Limb AmputeesPSINCT04947462

Proprioceptive Sensorimotor Integration With Neural Interfaces for Hand Prostheses

A study testing Chronically Implanted Neural and Muscular Interface in people with Upper Limb Amputees, run by VA Office of Research and Development at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to characterize proprioceptive sensations in the missing limb of upper limb amputees using nerve stimulation, and to develop advanced controllers for moving a prosthesis. Proprioceptive sensations are the sensations that tell individuals where their hand is in space, and if it is moving. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Upper Limb Amputees
What is being tested?
Chronically Implanted Neural and Muscular Interface
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteUnited States
Study dates
1 Dec 2021to 31 May 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Veteran
  • Unilateral upper limb amputation above or below the elbow with fully healed and healthy surgical sites
  • Viable peripheral nerve function in the residual nerves serving the limb
  • Volitional activity of the residual muscles in the amputated limb or actuating movement of the limb
  • Medically fit to undergo general anesthesia
  • Fitted with a prosthesis by a certified prosthetic and orthotic specialist (CPO) and at least one month of experience using a prosthesis
  • Willingness and availability to follow the study protocol
  • Willingness to undergo psychological evaluation, if recommended by study surgeons or investigators, to determine that the participant is mentally competent and capable of completing the study-related activities

Who cannot join

  • Bilateral upper limb amputation, unless the amputation on the contralateral side only involves missing digits but does not qualify as a partial hand amputation
  • Inability to speak English
  • Medically unfit to undergo surgery
  • Pregnancy, or those who are of childbearing potential, unwilling to prevent pregnancy during the trial
  • Uncontrolled diabetes (Hemoglobin A1c (HgbA1c)>8.0%)
  • History of neuropathy and/or radiculopathy in the target limb
Show all 11Show fewer
  • Active infection or open sores on the residual limb
  • History of frequent infection or sores with unknown cause
  • Inability to provide informed consent or follow experimental protocols
  • Severe pain that would prevent the participant from completing study-related activities
  • Poor surgical candidate

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting
  • Louis Stokes VA Medical Center, Cleveland, OH

    Cleveland, Ohio, 44106-1702

    Jessica R Jarvela, MS BS, (216) 791-3800 ext. 63801, Jessica.Jarvela@va.gov

    Melissa S Schmitt, (216) 791-3800 ext. 63801, Melissa.Schmitt@va.gov

    Recruiting

Other trials in United States

About this study

The purpose of this study is to characterize proprioceptive sensations in the missing limb of upper limb amputees using nerve stimulation, and to develop advanced controllers for moving a prosthesis. Proprioceptive sensations are the sensations that tell individuals where their hand is in space, and if it is moving. The research team uses Functional Electrical Stimulation (FES), which involves applying small electric currents to the nerves. These signals are then transferred to the brain just like the information about the individual's intact hand used to be transferred to their brain. This study will test different placements for stimulation and determine which one(s) provide the individual with proprioceptive sensations. The investigators want to know what the participants feel and if the investigators can use proprioceptive sensation to give the participants information about limb movement and position.

Read the detailed description

Hands are the primary means of interacting with the world, and Veterans who have lost a hand must cope with diminished functional and sensory capabilities. While myoelectric prostheses can restore the basic grasping function of the lost hand, many amputees abandon use of prostheses because current prosthetic options do not meet their needs. In addition, many amputees struggle with phantom pain and psychosocial deficits following limb loss that are not fully mitigated by current treatments.

In the normal sensorimotor system, proprioception, which is the sense of limb position and movement, is critical for informing motor plans and correcting errors in movement. In addition, proprioception plays a key role in body ownership, agency, and phantom pain. Despite its importance, proprioception is absent in current prosthetic options.

The goal of the proposed project is to make upper limb prosthetic devices more natural and useful for Veterans who have lost a hand by providing proprioceptive feedback about prosthesis postures and movements. The central hypothesis is that effectively closing the loop between a prosthesis user and their device requires that the sensory inputs and control outputs closely mimic the underlying sensorimotor neural processes of the body schema. The investigators will examine integration of artificial proprioception with prosthesis control in eight trans-radial or four trans-humeral amputees using the investigators' implanted neural-interfacing system and intramuscular EMG.

Aim 1. Characterize proprioceptive sensations elicited by peripheral nerve stimulation. The investigators will test time-varying Peripheral Nerve Stimulation (PNS) patterns and examine the impact on the kinematics of the evoked proprioceptive percept using position matching with the contralateral intact limb and multivariate regression analyses. The investigators will investigate paired agonist-antagonist stimulation strategies and compare the discriminability between agonist-only and paired agonist-antagonist strategies using psychometric tests. As well as assess the psychometric properties of PNS-evoked proprioceptive percepts and examine the interaction of proprioception with concurrent touch feedback and voluntary muscle contraction.

Aim 2. Investigate the mechanisms of stimulation-evoked proprioception. The neurophysiological basis of proprioception from PNS is unknown. To investigate whether proprioceptive percepts originate from direct afferent activation or indirect recruitment via direct muscle activation, the investigators will perform a motor block of the residual forearm of trans-radial participants and examine changes to the proprioceptive percepts. In trans-humeral participants, Targeted Muscle Reinnervation will be performed at the time of system implant, and percepts will be compared before and after muscle ingrowth.

Aim 3. Determine the integration of proprioceptive stimulation with motor control during posture matching. To restore proprioception to Veterans during active prosthesis use, PNS-evoked percepts must be integrated with voluntary limb control. The investigators will determine the impact of proprioception on motor control through a virtual reality posture matching task and compare performance with velocity and position-based prosthetic hand controllers with and without proprioceptive PNS. The investigators will determine the impact of voluntary control on the perception of PNS-evoked proprioception through a psychometric dissimilarity rating task. The investigators will assess the impact of artificial proprioception on embodiment via surveys. The investigators will also explore how control of multi-DOF movements with intramuscular EMG signals can be decoded via machine learning (ML)-based controllers by comparing the integration of proprioception with machine learning-based velocity control vs machine learning-based position control in virtual hand posture matching tasks. Investigators will access this impact by having the participants perform functional tasks in the laboratory with the best performing controller and a multi-DOF prosthetic hand with joint position sensors.

The project will be the first to investigate the sensorimotor integration of proprioception from PNS in a broad population of upper-limb amputees and with both position and velocity controllers. The study will provide important information about the kinematics of artificial proprioception and the role of direct muscle activation in forming proprioceptive percepts. The investigators expect that knowledge gained in this proposal will improve prosthesis utility and acceptance for Veterans with limb loss and will advance prosthetic hand technology and standard of care in the neurorehabilitation field.

Being tested
Chronically Implanted Neural and Muscular Interface
Keywords
Proprioception, Prosthesis, Upper Extremity Limb Loss, Peripheral Nerve Stimulation, Embodiment, Sensorimotor, Neuroprostheses

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Chronically Implanted Neural and Muscular InterfaceDevice

    Participants will be chronically implanted with neural and muscular interfaces to characterize proprioceptive sensations using Functional Electrical Stimulation (FES).

Study groups in NCT04947462
Study groupRoleWhat they receive
Chronically Implanted Neural and Muscular InterfaceExperimental8 eligible participants will be chronically implanted with neural and muscular interfaces to characterize proprioceptive sensations using Functional Electrical Stimulation (FES).
Receives: Device: Chronically Implanted Neural and Muscular Interface

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Magnitude of change in perceived joint position

    Magnitude of change in perceived joint position, as measured by joint angle transducers in the Cyberglove. As well as just noticeable difference (JND) of perceived magnitude, JND of perceived frequency, temporal detection threshold (TDT), and adaptation time constants for proprioceptive percepts

    Measured: This metric will be measured approximately each month for two years.

Secondary outcomes (2)
  1. Multi-Dof posture matching

    Participants will perform a multi-DOF posture matching task in virtual reality, where they will be asked to control multiple DOF simultaneously to achieve a multi-DOF target posture. Each controlled DOF will have a matched proprioceptive percept, and the number of DOF controlled in this task will be 2-4. Trial time will be the primary metric measure.

    Measured: This metric will be measured approximately each month for two years.

  2. Object Discrimination

    The participant will complete object discrimination tasks and simulated activities of daily living both with and without proprioceptive feedback. Identification accuracy will be the primary metric measure

    Measured: This metric will be measured approximately each month for two years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2021
  2. Study start1 Dec 2021
  3. Primary completion31 May 2030 (estimated)
  4. Study completion31 May 2030 (estimated)

Resources

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
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04947462
Sponsor's protocol ID
A3699-R
Other IDs
RX003699-01, 1624763, 1I01RD000699-01A2
Acronym
PSI
Status last verified
Aug 2026
First submitted
23 Jun 2021
Last updated
21 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Wright JD, Charkhkar H, Graczyk EL. Mind the gap: the temporal discrimination threshold of tactile sensation from implanted peripheral nerve stimulation. J Neuroeng Rehabil. 2026 Apr 18;23(1):179. doi: 10.1186/s12984-026-01986-9.

    PubMed 42001150

Questions about this trial

What is this clinical trial studying?

A study testing Chronically Implanted Neural and Muscular Interface in people with Upper Limb Amputees, 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 8 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 21 Aug 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Emily L Graczyk, PhD ((216) 791-3800 ext. 63571, Emily.Graczyk@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Magnitude of change in perceived joint position (time frame: This metric will be measured approximately each month for two years.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04947462, which also lists 1 linked publication.

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 21 Aug 2026.

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