What side effects are associated with this type of intervention?

Common side effects of neuromodulation treatments for chronic pain, such as transcutaneous electrical nerve stimulation (TENS), spinal cord stimulation (SCS), and peripheral nerve stimulation (PNS), include mild skin irritation, redness, itching, tingling, and muscle spasms at the site of electrode placement. More invasive procedures like SCS may also carry risks of infection, lead migration, and hardware malfunction. Serious adverse events are rare but can include nerve damage or neurological injury.

What prior FDA approvals exist?

The FDA has approved several treatments for chronic pain that involve electrical stimulation, similar to the Neuronoff PNS Injectrode F1. Transcutaneous electrical nerve stimulation (TENS) devices, which deliver electrical impulses through the skin to stimulate nerves and reduce pain, have been widely used and approved. Additionally, spinal cord stimulation (SCS) devices, which involve implanting electrodes near the spinal cord to modulate pain signals, have also received FDA approval. Specific devices like the Stimwave Freedom-4, a miniaturized neurostimulator for dorsal root ganglion (DRG) stimulation, have been approved for conditions such as failed back surgery syndrome (FBSS). These treatments offer non-pharmacological options for managing chronic pain.

What other types of research exist?

Promising alternatives to the Neuronoff PNS Injectrode F1 for chronic pain patients include: 1) High-frequency spinal cord stimulation (SCS), which has shown improved pain relief and patient satisfaction. 2) Dorsal root ganglion (DRG) stimulation, effective for focal chronic pain conditions. 3) Burst stimulation, which mimics natural nerve firing patterns and may reduce pain more effectively. 4) Peripheral nerve stimulation (PNS) with newer, miniaturized, and wireless devices that offer targeted pain relief with fewer side effects. 5) Advanced radiofrequency ablation techniques, which provide longer-lasting pain relief by disrupting nerve signals.

← Back to Search

Lumbar Injectrode Feasibility Evaluation (LIFE Trial)

Phase 1

Waitlist Available

Led By Amol Soin, MD, MBA

Research Sponsored by Neuronoff, Inc

Eligibility Criteria Checklist

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

Must have

Be 21 years of age or older when written informed consent is obtained

Literate, able to speak English and able to complete questionnaires independently

Must not have

If female, have a positive pregnancy test at the screening and/or Day 0 visit

Have a skin condition at the planned surgical location

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 35 days

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a small device that sends electrical signals to a nerve in the lower back. It aims to see if these signals can safely activate a muscle in that area. Healthy volunteers will use the device for several weeks to check its safety and effectiveness.

Who is the study for?

This trial is for healthy volunteers experiencing chronic lower back pain. Participants must be willing to have the PNS Injectrode F1 device inserted near their lumbar medial branch nerve and keep it in place for up to 28 days. Specific inclusion and exclusion criteria details are not provided, but typically involve factors like age, health status, and other medical conditions.

What is being tested?

The study tests if the Neuronoff PNS Injectrode F1 can be safely inserted and used to stimulate a specific back nerve (lumbar medial branch) to activate a muscle (multifidus). It involves transcutaneous stimulation before and after insertion of the device, which remains implanted for up to four weeks.

What are the potential side effects?

While specific side effects are not listed, potential risks may include discomfort at the injection site, infection risk from implantation, possible allergic reactions or tissue damage due to electrical stimulation.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am 21 years old or older.

Select...

I can read, speak English, and fill out forms by myself.

Select...

I can undergo minor electrical stimulation treatments.

Exclusion Criteria

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

Select...

I am not pregnant, as confirmed by a test.

Select...

I have a skin condition where my surgery is planned.

Select...

I have a health issue that prevents me from having minor surgeries.

Select...

I have a heart rhythm problem that affects my blood pressure.

Select...

I currently have an infection.

Select...

I experience more than 2 seizures a month.

Select...

I have not used any experimental drugs or devices in the last 30 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 35 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~35 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 35 days for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Incidence of Serious Adverse Device Effects (SADEs)

Proportion of Subjects with Multifidus Muscle Activation as determined by PI via Ultrasound Imaging and Palpation

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: PNS Injectrode F1Experimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PNS Injectrode F1

2024

Completed Phase 1

~10

0 / 10Eligibility 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 chronic pain, such as Transcutaneous Electrical Nerve Stimulation (TENS) and Spinal Cord Stimulation (SCS), work by delivering electrical impulses to specific nerves. These impulses modulate pain signals before they reach the brain, reducing the perception of pain and improving function. This is particularly relevant for chronic pain patients as it offers a non-pharmacological option that targets specific nerve pathways, potentially providing relief when other treatments have failed.