Sensory Feedback for Prosthetics in Amputees

(NISRL Trial)

Overseen By Jacob L Segil, PhD MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Other musculoskeletal injuries

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to make prosthetic hands feel more like a natural part of the body by providing sensory feedback, which most prosthetics currently lack. Researchers are testing new technologies, including the Peripheral Nerve Interface, to help users feel touch and movement through their prosthetic hands, potentially improving usefulness and comfort. Participants may include individuals with an upper limb difference who wish to try a prosthetic that feels more natural. The study will explore various methods of providing this feedback to determine which works best. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could significantly enhance the quality of life for prosthetic users.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this device is safe for upper limb amputees?

Research has shown that connecting nerves to prosthetic limbs is generally safe. Studies have found that these connections, known as peripheral nerve interfaces, are usually well-tolerated. For instance, they have been used successfully in individuals with upper limb amputations to help control prosthetic fingers.

Some minor side effects have been reported, but they are typically easy to manage. These may include mild discomfort or irritation at the device placement site. The primary purpose of these nerve connections is to help users feel touch and movement in their prosthetic limbs, and they have shown promise in achieving this goal.

This technology has developed over time and continues to improve in safety and effectiveness. For those considering joining a trial for this technology, research supports its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the potential of sensory feedback for prosthetics because it aims to enhance the feeling of embodiment in upper limb amputees. Unlike traditional prosthetics that may lack sensory feedback, this approach seeks to provide users with a more intuitive and lifelike experience by delivering sensory information from the prosthetic hand back to the user. This could lead to improved control and a sense of ownership over the prosthetic, potentially making it feel more like a natural extension of the body. The focus on maximizing sensory channels and targeting specific sensory locations sets this approach apart from current options, potentially leading to a more seamless integration of prosthetic devices into daily life.

What evidence suggests that this trial's treatments could be effective for upper limb amputees?

Research has shown that adding sensory feedback to prosthetic hands significantly enhances their usefulness for users. This trial will involve participants in different experimental arms to explore these effects. Studies have found that when individuals with prosthetics receive touch and movement feedback, they feel more connected to their prosthetic, making it seem like a natural part of their body. In some studies, this feedback greatly improved their sense of control and reduced phantom pain, which is pain felt where the missing limb used to be. For example, one study found that users experienced better control and less discomfort when sensory feedback was included. This suggests that sensory feedback could make prosthetic hands more effective and comfortable for amputees. ^{6 7 8 9 10}

Who Is on the Research Team?

Jacob L. Segil, PhD MS

Principal Investigator

Rocky Mountain Regional VA Medical Center, Aurora, CO

Are You a Good Fit for This Trial?

This trial is for both veterans and non-veterans who have an upper limb amputation or are able-bodied. It's not open to individuals with other musculoskeletal injuries.

Inclusion Criteria

Both people who have served in the military and those who haven't are allowed to participate.

I am either fully able-bodied or have a difference in my upper limb.

Exclusion Criteria

I have no other injuries to my bones or muscles.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Normative Data Collection

Quantify the embodiment of conventional prosthetic hand options using a modified Rubber Hand Illusion protocol

12 weeks

4 visits (in-person)

Device Development

Design of multi-modal sensors to study full-hand embodiment

16 weeks

Characterization of Embodiment

Quantify the effects of peripheral nerve stimulation on the embodiment of prosthetic hands

20 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Investigation of Embodiment for Upper Limb Amputees
• Peripheral Nerve Interface
• Prosthetic hand

Trial Overview The study tests a new way of making prosthetic hands feel more like real ones by using peripheral nerve interfaces. It aims to make the prosthesis embody sensation, measuring how well it works through three main tasks: collecting data on current prosthetics, developing sensors for full-hand feeling, and experimenting with nerve stimulation effects.

How Is the Trial Designed?

Group I: Aim 3 Experimental Treatment 1 Intervention

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.

Group II: Aim 1 Experimental Treatment 1 Intervention

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).

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

Current prostheses for individuals with upper limb amputation or congenital limb difference are inadequate, leading to issues like rejection and pain, highlighting the need for improved solutions.

Emerging technologies such as robotic limbs and osseointegrated prostheses show promise in meeting user needs, but they also introduce new risks that must be carefully evaluated through user perspectives and feedback.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Upper extremity prosthesis user perspectives on unmet needs and innovative technology. Benz, HL., Jia Yao, ., Rose, L., et al.[2022]

The paper reviews various techniques for restoring sensory function in upper limb amputees, focusing on sensory substitution and modality-matched feedback methods.

These methods aim to provide amputees with sensory feedback, each having unique advantages and disadvantages, which can enhance the functionality and user experience of prosthetic devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sensory feedback in upper limb prosthetics. Antfolk, C., D'Alonzo, M., Rosén, B., et al.[2013]

Citations

1. grantome.com grantome.com/grant/NIH/IK2-RX003282-01A2

Investigation of Embodiment for Upper Limb Amputees This investigation of embodiment for upper limb amputees is organized into three main areas of work including 1) normative data collection, 2) device ...

2. withpower.com withpower.com/trial/phase-5-2022-509a9

Sensory Feedback for Prosthetics in Amputees (NISRL Trial) This investigation of embodiment for upper limb amputees is organized into three main areas of work including 1) normative data collection, 2) device ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7324654/

A Review of Sensory Feedback in Upper-Limb Prostheses ... This manuscript reviews historical and recent studies that focus on supplementary sensory feedback for use in upper limb prostheses.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02189031

Sensory Feedback for Touch and Proprioception With ... The investigators research is focused on helping these individuals to feel where their prosthetic limbs are moving without having to look at them by developing ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6166773/

Motor Control and Sensory Feedback Enhance Prosthesis ... We quantified prosthesis embodiment and phantom pain reduction associated with motor control and sensory feedback from a prosthetic hand in one human with a ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12086952/

Investigating the Feasibility and Safety of Osseointegration ... This review explores advancements in ONIs, including screw-fit and press-fit systems and their integration with PNIs for bidirectional communication.

7. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-020-00667-5

Interfaces with the peripheral nervous system for the control of ... In this paper, we broadly review the techniques used to bridge the patient's peripheral nervous system to a prosthetic limb.

8. science.org science.org/doi/10.1126/scitranslmed.aay2857

A regenerative peripheral nerve interface allows real-time ... Regenerative peripheral nerve interfaces (RPNIs) implanted in upper limb amputees allowed the control of finger movements using hand prosthesis for almost a ...

9. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/ana.27287

Toward Natural Limb Function: A New Era in Prosthetic ... Peripheral Nerve Interface. Another popular approach to neuroprosthetic limb control is through interfacing with peripheral nerves to extract ...

10. edhub.ama-assn.org edhub.ama-assn.org/vha-education/module/2825579

Neural-Enabled Prostheses for Sensory Restoration Insert Peripheral nerve stimulation (PNS) uses electrical stimulation to activate nerves and has shown promise in restoring tactile and proprioceptive ...