Sensory Feedback Stimulation for Amputees

Overseen By Aarika Sheehan, PT, DPT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Louis Stokes VA Medical Center

Disqualifiers: Uncontrolled diabetes, Vascular disease, Infections, others

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

Compensation: Varies

Number of Visits: 1

15 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the effectiveness of providing sensation of the missing limb to individuals with lower limb loss, including above and below knee amputees. The approach involves delivering small electrical currents directly to remaining nerves via implanted stimulating electrodes. These small electrical currents cause the nerves to generate signals that are then transferred to your brain similar to how information about the foot and lower limb used to be transferred to your brain prior to the amputation. Individuals also have the option to have recording electrodes implanted within muscles of the lower limb(s) in an attempt to develop a motor controller that would enable the user to have intuitive control of a robotic prosthetic leg.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What data supports the effectiveness of the treatment Multi contact electrode implant for sensory feedback stimulation in amputees?

Research shows that implanted nerve interfaces can provide stable, natural touch sensations for amputees, improving their ability to control prosthetic devices and manipulate objects. Additionally, similar treatments have been shown to enhance mobility, reduce phantom limb pain, and increase confidence in using prosthetic limbs. ^{1 2 3 4 5}

Is sensory feedback stimulation for amputees generally safe for humans?

Research shows that sensory feedback stimulation, including methods like implanted nerve interfaces and transcutaneous electrical nerve stimulation (TENS), has been used safely in humans. Studies report stable and natural touch sensations without adverse effects over long periods, suggesting it is generally safe for human use. ^{2 4 5 6 7}

How does the Multi contact electrode implant treatment for amputees differ from other treatments?

The Multi contact electrode implant treatment is unique because it uses implanted electrodes to provide natural touch sensations directly to the nerves, allowing amputees to feel different types of touch on their phantom hand. This approach offers stable, long-term sensory feedback, unlike other treatments that may not provide direct or natural sensation. ^{1 2 5 8 9}

Research Team

Ronald Triolo, PhD

Principal Investigator

Louis Stokes VA Medical Center

Eligibility Criteria

This trial is for adults over 18 with lower limb amputations who may use prostheses for standing or walking. They must have good nerve function in the remaining limb, stable health, and no severe skin issues. Excluded are those with chronic infections, obesity (BMI > 35), uncontrolled diabetes, balance disorders, significant mental health issues, or a need for MRI during the study.

Inclusion Criteria

My leg nerves respond well to standard tests.

I have had a stable leg amputation above or below the knee for over 3 months.

Exclusion Criteria

I experience significant pain in the part of my body where I had an amputation.

I have arthritis near where my implant is located.

I am not a good candidate for surgery.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Implantation

Electrodes are surgically implanted on nerves and muscles of the residual limb

1-2 weeks

1 visit (in-person)

Experimental Testing

Participants receive electrical stimulation and engage in functional tasks with the sensory neuroprosthesis

9 months

Regular visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the experimental testing

3 months

Treatment Details

Interventions

• Multi contact electrode implant

Trial Overview The trial tests if stimulating nerves through implanted electrodes can restore sensation to amputees' missing limbs. It also explores whether recording electrodes in muscles can help control a robotic prosthetic leg intuitively.

Participant Groups

Group I: Stimulating nerve electrodes & intramuscular recording electrodes Experimental Treatment 1 Intervention

Fifteen subjects with lower limb amputation will have multi-contact stimulating nerve cuff electrodes implanted around the nerves in their residual limb. These electrodes will be connected to temporary percutaneous leads. During experimental testing, a small amount of electrical current will be delivered to the nerves through multi-contact nerve cuff electrodes. Participants also have the option to have recording electrodes implanted within muscles in their lower limb(s). These muscles are associated with prosthetic movement, and recordings from these muscles will be used to develop a controller for a robotic myoelectric prosthesis.

Who Is Running the Clinical Trial?

Louis Stokes VA Medical Center

Lead Sponsor

Trials

21

Recruited

4,100+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Case Western Reserve University

Collaborator

Trials

314

Recruited

236,000+

Findings from Research

A new sensory feedback system using transcutaneous electrical nerve stimulation (TENS) has been developed to help amputees perceive touch through their prosthetic hands, addressing a major challenge in prosthetic technology.

Preliminary tests with amputee subjects showed that they could distinguish different levels of pressure applied to the prosthetic fingers, indicating that this system effectively restores tactile sensation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A sensory feedback system for prosthetic hand based on evoked tactile sensation. Liu, XX., Chai, GH., Qu, HE., et al.[2020]

Implanted peripheral nerve interfaces provided stable and natural touch sensations in two human subjects with upper limb amputation for over 1 year, demonstrating the potential for long-term sensory restoration.

Electrical stimulation of peripheral nerve cuff electrodes allowed subjects to experience various tactile perceptions, such as tapping and vibration, which improved their ability to control prosthetic grasping strength and manipulate delicate objects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A neural interface provides long-term stable natural touch perception. Tan, DW., Schiefer, MA., Keith, MW., et al.[2022]

A new leg neuroprosthesis developed for transfemoral amputees successfully provided real-time sensory feedback through nerve stimulation, leading to improved mobility and fall prevention during active tasks.

The study demonstrated that this sensory feedback increased the embodiment of the prosthesis and reduced cognitive effort during tasks, suggesting that integrating sensory feedback can significantly enhance the quality of life for amputees.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing functional abilities and cognitive integration of the lower limb prosthesis. Petrini, FM., Valle, G., Bumbasirevic, M., et al.[2020]

The study involved two transfemoral amputees using a neuroprosthetic device that provided sensory feedback through intraneural stimulation, leading to increased walking speed and confidence while reducing mental and physical fatigue.

Participants also experienced a decrease in phantom limb pain when receiving neural sensory feedback, suggesting that restoring sensory information could significantly improve the quality of life for above-knee amputees.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sensory feedback restoration in leg amputees improves walking speed, metabolic cost and phantom pain. Petrini, FM., Bumbasirevic, M., Valle, G., et al.[2022]

A non-invasive method using transcutaneous electrical nerve stimulation (TENS) successfully induced sensations in the phantom hands of amputees, providing sensory feedback that corresponds to the innervation regions of the median and ulnar nerves.

This sensory feedback allowed amputees to perform complex tasks with their prostheses, such as applying varying levels of force, suggesting that TENS could be a practical alternative to surgical interventions for restoring sensory feedback.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A somatotopic bidirectional hand prosthesis with transcutaneous electrical nerve stimulation based sensory feedback. D'Anna, E., Petrini, FM., Artoni, F., et al.[2019]

The study successfully applied the Rubber Hand Illusion concept to the lower limb, showing that 19 healthy participants could perceive ownership of a rubber foot when receiving synchronized vibrotactile stimulation on both their biological foot and the rubber foot.

The illusion of body ownership was enhanced with matched stimulation but could still be achieved with mismatched stimulation, suggesting potential for developing sensory feedback devices for amputees to improve their experience with prosthetics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The rubber foot illusion. Crea, S., D'Alonzo, M., Vitiello, N., et al.[2022]

Vibrotactile stimulation on the upper leg was well perceived by ten healthy subjects, indicating its potential for providing feedback in prosthetic applications.

The study explored various aspects of vibrotactile feedback, including perception at different frequencies and locations, but further research is needed to assess its effectiveness specifically for trans-femoral prostheses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vibrotactile stimulation of the upper leg: effects of location, stimulation method and habituation. Wentink, EC., Mulder, A., Rietman, JS., et al.[2020]

A novel tactile feedback system for prosthetic hands was developed, integrating a flexible sensing array with 16 sensors and a matrix of 24 stimulation pads, allowing users to receive detailed touch feedback.

In tests with six able-bodied subjects, the system achieved high recognition rates for static patterns (91% for low resolution) and dynamic movements (94% for sliding touch), indicating its potential to enhance the user experience and control of bionic limbs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Embedded Electrotactile Feedback System for Hand Prostheses Using Matrix Electrode and Electronic Skin. Abbass, Y., Saleh, M., Dosen, S., et al.[2022]

Current prosthetic devices lack the ability to provide natural sensory feedback, which leads to unnatural movements and difficulties in controlling the prosthetic, potentially causing health issues for users.

There is a significant clinical need for devices that can restore sensory feedback by mimicking the complex signals from skin, muscles, and joints, and various neurotechnological approaches are being explored to achieve this for amputees.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sensory feedback for limb prostheses in amputees. Raspopovic, S., Valle, G., Petrini, FM.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

A sensory feedback system for prosthetic hand based on evoked tactile sensation. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

A neural interface provides long-term stable natural touch perception. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Enhancing functional abilities and cognitive integration of the lower limb prosthesis. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Sensory feedback restoration in leg amputees improves walking speed, metabolic cost and phantom pain. [2022]

5. England pubmed.ncbi.nlm.nih.gov

A somatotopic bidirectional hand prosthesis with transcutaneous electrical nerve stimulation based sensory feedback. [2019]

6. England pubmed.ncbi.nlm.nih.gov

The rubber foot illusion. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Vibrotactile stimulation of the upper leg: effects of location, stimulation method and habituation. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Embedded Electrotactile Feedback System for Hand Prostheses Using Matrix Electrode and Electronic Skin. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Sensory feedback for limb prostheses in amputees. [2023]