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

Trial Summary

What is the purpose of this trial?

The investigators will investigate the device feasibility of human peripheral nerves and muscles recording and stimulation using percutaneous Utah Slanted Electrode Arrays (pUSEAs) implanted into residual peripheral arm nerves and EMG electrodes implanted in the residual muscles of patients with limb amputations in order to determine the ability of the HAPTIX (Hand Proprioception and Touch Interfaces) System to control an upper-extremity prosthesis, and to provide a sense of cutaneous touch and muscle proprioceptive feedback to the amputee.

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 data supports the effectiveness of the HAPTIX System for Amputees treatment?

Research shows that Utah Slanted Electrode Arrays (USEAs) can help restore motor and sensory functions by recording and stimulating nerves, which is promising for amputees. Studies have demonstrated successful long-term use of these arrays in both human and animal models, indicating their potential to improve quality of life for individuals with nerve damage or limb loss. ^{1 2 3 4 5}

How is the HAPTIX System for Amputees treatment different from other treatments for amputees?

The HAPTIX System for Amputees uses percutaneous Utah Slanted Electrode Arrays (pUSEAs) to directly interface with nerves and muscles, allowing for precise motor control and sensory feedback, which is unique compared to traditional prosthetics that do not provide such direct neural integration. ^{1 2 3 5 6}

Research Team

Douglas Hutchinson, M.D.

Principal Investigator

University of Utah Orthopaedics

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Clinical applications of penetrating neural interfaces and Utah Electrode Array technologies. [2018]

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

Control of skeletal muscle force with currents injected via an intrafascicular, microelectrode array. [2020]

3. England 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. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Chronic recording and electrochemical performance of amorphous silicon carbide-coated Utah electrode arrays implanted in rat motor cortex. [2021]

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

Recording sensory and motor information from peripheral nerves with Utah Slanted Electrode Arrays. [2020]

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

Functional neuromuscular stimulation system using an implantable hydroxyapatite connector and a microprocessor-based portable stimulator. [2013]