What side effects are associated with this type of intervention?

Treatments for diabetic neuropathy involving electrical stimulation of nerves, such as the use of stimulating electrodes, can cause mild side effects. These may include sensations of warmth, numbness in the arm or hand, redness, itching, tingling, muscle spasms, and pain in the arm, shoulder, or neck. Serious adverse events are rare.

What prior FDA approvals exist?

The FDA has approved several neuromodulation devices for the treatment of various types of neuropathic pain, including diabetic neuropathy. One such device is the transcutaneous electrical nerve stimulation (TENS) unit, which delivers electrical impulses to nerves to alleviate pain. Another example is spinal cord stimulation (SCS), which involves implanting a device that sends electrical pulses to the spinal cord to reduce pain signals. These treatments are similar to the stimulating electrodes being studied for restoring lower limb sensation in diabetic peripheral neuropathy.

What other types of research exist?

Promising novel alternatives to stimulating electrodes for diabetic neuropathy patients include: 1) Percutaneous and transcutaneous tibial nerve stimulation, which has shown efficacy in treating overactive bladder and may have potential for neuropathy. 2) Carbon nanotube yarn (CNTy) electrodes, which offer fine sensory feedback and lower current thresholds. 3) Spinal cord stimulation, particularly high-frequency and closed-loop systems, which have been effective in managing chronic pain and may benefit neuropathy patients. These alternatives are under investigation and may provide new avenues for treatment in 2024.

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Neurostimulation Device

Nerve Stimulation for Diabetic Neuropathy

N/A

Recruiting

Led By Ronald Triolo, PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Being ambulatory and ability to stand or walk with prosthesis or orthosis

Chronic, medically stable lower limb amputation due to diabetes or insensate foot due to Diabetic peripheral neuropathy

Must not have

Arthritis in the area of implant- Inflammation or stiffness in the area of implant could limit placement of the electrodes

Significant history of uncontrolled infections

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years post implant

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to help people who have lost a leg by using small devices that send electrical signals to nerves and record muscle activity. These signals help the brain feel sensations from the missing limb, and the muscle data helps control a robotic leg more naturally.

Who is the study for?

This trial is for individuals with lower limb loss above or below the knee due to diabetes, who can walk or stand with assistance and have healthy nerves in their remaining limbs. They should have good skin health, no autoimmune issues, seizures, heart problems, and must be able to follow the study plan. Excluded are those with uncontrolled diabetes (HbA1c ≥ 8.5%), active skin ulcers, pregnancy, language barriers (non-English speakers), balance disorders, severe obesity (BMI > 35), mental health issues that affect study participation.

What is being tested?

The trial tests implanted electrodes that provide sensation to nerves in the residual limb of amputees simulating natural feedback from a lost foot or leg. Additionally offered is an option for muscle recording electrodes aimed at creating intuitive control over robotic prosthetic legs through a motor controller.

What are the potential side effects?

Potential side effects may include discomfort at electrode sites, possible skin irritation or infection risks associated with implants. There might also be unexpected nerve responses leading to pain or abnormal sensations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can walk or stand using a prosthesis or brace.

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I have a stable lower limb amputation or insensate foot due to diabetes.

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I do not have autoimmune deficiencies, seizures, or heart problems that prevent stimulation treatments.

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My leg nerves respond well to standard nerve tests.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have arthritis near where a medical device was implanted.

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I have a history of infections that were hard to control.

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My diabetes is not under control, with an HbA1c of 8.5% or higher.

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I have serious blood vessel problems.

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I have ongoing skin sores or ulcers.

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I have a history of disorders affecting my balance or walking.

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My BMI is over 35, indicating I have class II or III obesity.

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I currently have an infection.

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I experience significant pain in my foot, including after amputation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years post implant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years post implant

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years post implant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Functional Gait Assessment (FGA)

Stimulation thresholds

Secondary study objectives

Neuropathic Pain Syndrome Inventory (NPSI)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Multi contact electrode implant and implanted electromyography recording electrodesExperimental Treatment1 Intervention

Fifteen subjects with lower limb amputation will receive implanted multicontact stimulating nerve cuff electrodes connected to temporary percutaneous leads. During experimental testing, a small amount of stimulation will be applied to the nerves through the contacts of the multichannel cuff electrode.

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for diabetic neuropathy include the use of antioxidants like alpha-lipoic acid, antiepileptic drugs such as gabapentin, and electrical stimulation of nerves. Alpha-lipoic acid works by reducing oxidative stress and improving nerve blood flow, which can alleviate symptoms. Gabapentin modulates neurotransmitter release to reduce pain. Electrical stimulation of nerves, as studied in trials with stimulating electrodes, sends small electrical currents to remaining nerves, mimicking natural nerve signals to the brain. This can help restore sensation and improve motor control. Understanding these mechanisms is crucial for patients as it highlights how these treatments can alleviate symptoms, improve quality of life, and potentially slow disease progression.