HAPTIX System for Amputees

Overseen By Douglas Hutchinson, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

Disqualifiers: Incarceration, Pregnancy, Psychiatric, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 2 years

3 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new system that helps individuals with arm amputations control a prosthetic limb and experience sensations like touch and movement. The treatment uses small devices called percutaneous Utah Slanted Electrode Arrays (pUSEAs), implanted in the nerves and muscles of the arm to determine if they can improve prosthetic arm function. Individuals who have lost one or both arms below the elbow might be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could enhance prosthetic technology for future patients.

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 the HAPTIX System is safe for amputees?

Research has shown that the Utah Slanted Electrode Arrays (USEAs) have been tested in studies involving individuals who have lost limbs. In these studies, the electrodes restored a sense of touch and movement. The results indicated that the treatment was generally well-tolerated. Specifically, the electrodes provided up to 81 different types of sensations to participants, demonstrating their effectiveness.

Regarding safety, long-term use of these electrodes has been studied. This research examined the devices' performance and stability over time. The electrodes remained reliable and did not cause major problems for users, suggesting safe long-term use in humans.

Overall, existing data supports the safety of the Utah Slanted Electrode Arrays for human use, particularly in helping individuals with amputations regain sensations and control. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional prosthetics that rely on external sensors or mechanical connections, the percutaneous Utah Slanted Electrode Arrays (pUSEAs) are directly implanted and interact with nerve endings. This approach aims to restore sensation and improve control by stimulating the nerves that once controlled the amputated limb, potentially leading to a more natural and intuitive use of prosthetics. Researchers are excited about this treatment because it offers the possibility of enhancing the user's experience by providing real-time sensory feedback, which could significantly improve the quality of life for amputees.

What evidence suggests that the HAPTIX System is effective for amputees?

Research has shown that the percutaneous Utah Slanted Electrode Array (pUSEA), which participants in this trial will receive, can help amputees feel touch and control their prosthetic limbs more effectively. When placed in the nerves of amputees, these devices can create a wide range of sensations. For instance, one study found that users experienced up to 81 different feelings. The devices have also proven effective over time. Another study demonstrated that these devices can help amputees regain control and the sensation of movement. This suggests that pUSEAs could significantly enhance prosthetic limb function. ^{1 2 3 5 6}

Who Is on the Research Team?

Douglas Hutchinson, M.D.

Principal Investigator

University of Utah Orthopaedics

Are You a Good Fit for This Trial?

This trial is for adults under 65 with one or both arms amputated at the forearm level. Candidates must be able to give consent and not have health issues that make anesthesia very risky. Pregnant individuals, prisoners, or those with certain psychiatric conditions cannot participate.

Inclusion Criteria

I have had one or both of my arms amputated above the wrist.

Exclusion Criteria

Pregnancy

Psychiatric comorbidity

Incarceration

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implantation and Initial Testing

Implantation of percutaneous Utah Slanted Electrode Arrays (pUSEAs) and initial testing of neural recording and stimulation

4-8 weeks

Treatment

Participants use the HAPTIX System to control a prosthetic device and receive sensory feedback

Up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• percutaneous Utah Slanted Electrode Arrays (pUSEAs)

Trial Overview The study tests if tiny electrodes implanted in nerves of the arm stump can record signals and help control a prosthetic limb while providing touch feedback. The device called pUSEAs will be used alongside muscle sensors as part of the HAPTIX System.

How Is the Trial Designed?

Group I: Implantation of a percutaneous Utah Slanted Electrode Arrays (pUSEAs) Experimental Treatment 1 Intervention

The arm (s) of the patient which has been amputated. Intervention include insertion of the percutaneous Utah Slanted Electrode Arrays which will interact with nerve endings in order to gain knowledge about device feasibility and nerve stimulation.

percutaneous Utah Slanted Electrode Arrays (pUSEAs) is already approved in United States for the following indications:

Approved in United States as Utah Slanted Electrode Array for:

• Upper-extremity prosthetic control
• Cutaneous touch feedback
• Muscle proprioceptive feedback

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Published Research Related to This Trial

High-count penetrating microelectrode arrays (USEAs) implanted in peripheral nerves have successfully recorded nerve activity for up to 4 months, showing promise for long-term monitoring and potential restoration of motor and sensory functions after nerve damage.

Improvements in the containment system have significantly reduced contamination from myoelectric activity, allowing for clearer recordings in moving animals, which is crucial for developing real-time control of prosthetic limbs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recording sensory and motor information from peripheral nerves with Utah Slanted Electrode Arrays. Clark, GA., Ledbetter, NM., Warren, DJ., et al.[2020]

Recent advancements in penetrating microelectrode arrays, such as Utah electrode arrays, have shown promise in recording motor commands from the central nervous system, which could lead to improved therapies for motor disorders.

These microelectrode arrays can also evoke sensory perceptions in the peripheral nervous system, suggesting their potential to enhance the quality of life for patients with neurological disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical applications of penetrating neural interfaces and Utah Electrode Array technologies. Normann, RA., Fernandez, E.[2018]

Percutaneous implants made of hydroxyapatite (HAp) have been successfully tested in both dogs and humans for up to 30 months, showing good integration with skin tissue, which suggests their safety and potential for long-term use in functional neuromuscular stimulation (FNS) orthoses.

The developed microprocessor-based stimulator effectively delivered electrical stimuli to muscles, demonstrating its capability to elicit muscle contractions in a C5 quadriplegic patient, indicating its efficacy in restoring muscle function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional neuromuscular stimulation system using an implantable hydroxyapatite connector and a microprocessor-based portable stimulator. Akazawa, K., Makikawa, M., Kawamura, J., et al.[2013]

The study involved three human participants with chronic implantation of Utah Slanted Electrode Arrays (USEAs) and intramuscular recording leads (iEMGs) to restore sensorimotor function after transradial amputations, showing that neural recordings from USEAs can persist for over 500 days in one subject, indicating long-term viability.

While the performance of USEAs generally declines over time, they still provide consistent sensory percepts and stable signal quality, suggesting that with further improvements, these devices could enhance the restoration of function in amputees.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term performance of Utah slanted electrode arrays and intramuscular electromyographic leads implanted chronically in human arm nerves and muscles. George, JA., Page, DM., Davis, TS., et al.[2022]

Directly implanted electrodes, like the Utah Slanted Electrode Array, can effectively stimulate nerves to reanimate limbs in spinal cord injured patients, addressing significant issues found with surface and other external electrodes.

This approach potentially improves the efficacy of muscle stimulation by providing a more reliable and targeted method of interfacing with the nervous system, enhancing the overall effectiveness of rehabilitation efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Control of skeletal muscle force with currents injected via an intrafascicular, microelectrode array. Normann, R., McDonnall, D., Clark, G.[2020]

The study successfully demonstrated that Utah electrode arrays (UEAs) can be coated with biocompatible amorphous silicon carbide (a-SiC) and sputtered iridium oxide film (SIROF), allowing for effective single-unit recordings in rat motor cortex over a 30-week period.

Despite a decline in active electrode yield from 94.6% to 16.4% over the implantation period, some UEAs maintained over 60% active yield for extended durations, suggesting that a-SiC could be a promising alternative to traditional polymer coatings for enhancing the longevity and reliability of implantable microelectrode devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic recording and electrochemical performance of amorphous silicon carbide-coated Utah electrode arrays implanted in rat motor cortex. Joshi-Imre, A., Black, BJ., Abbott, J., et al.[2021]

Citations

1. researchgate.net researchgate.net/publication/321291592_Restoration_of_motor_control_and_proprioceptive_and_cutaneous_sensation_in_humans_with_prior_upper-limb_amputation_via_multiple_Utah_Slanted_Electrode_Arrays_USEAs_implanted_in_residual_peripheral_arm

(PDF) Restoration of motor control and proprioceptive and ... A Utah Slanted Electrode Array (USEA) has been used in the past to provide up to 81 sensory percepts for human amputees. Here, we report on the ...

2. iopscience.iop.org iopscience.iop.org/article/10.1088/1741-2552/abc025

Long-term performance of Utah slanted electrode arrays ... We explore the long-term performance and stability of seven percutaneous Utah Slanted Electrode Arrays (USEAs) and intramuscular recording leads (iEMGs) ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33045689/

Long-term performance of Utah slanted electrode arrays ... We explore the long-term performance and stability of seven percutaneous Utah Slanted Electrode Arrays (USEAs) and intramuscular recording leads (iEMGs) ...

4. biorxiv.org biorxiv.org/content/10.1101/2020.03.30.016683.full

Long-Term Performance of Utah Slanted Electrode Arrays ... We explore the long-term performance and stability of seven percutanous Utah Slanted Electrode Arrays (USEAs) and intramuscular recording leads (iEMGs) ...

5. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-021-00808-4

Discriminability of multiple cutaneous and proprioceptive hand ... Methods. We implanted Utah Slanted Electrode Arrays (USEAs) in the arm nerves of three transradial amputees and delivered electrical stimulation ...

6. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-017-0320-4

Restoration of motor control and proprioceptive and ... A Utah Slanted Electrode Array (USEA) has been used in the past to provide up to 81 sensory percepts for human amputees. Here, we report on the ...