Nerve Stimulation for Peripheral Neuropathy

Overseen By Saba Javed, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Cognitive dysfunction, Drug abuse, Infections, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 8 weeks

10 Participants Needed

Trial Summary

What is the purpose of this trial?

To learn if peripheral nerve stimulation (PNS) can help to improve pain in participants with CIPN.

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 trial coordinators or your doctor.

What data supports the effectiveness of the treatment Peripheral Nerve Stimulation for Peripheral Neuropathy?

Peripheral Nerve Stimulation (PNS) has been shown to provide significant pain relief in cases where other treatments have failed, such as intractable neuropathic pain after surgery. It is effective for various chronic pain conditions, including neuropathic pain, and recent advancements in PNS technology have improved its safety and effectiveness. ^{1 2 3 4 5}

How is Peripheral Nerve Stimulation treatment different from other treatments for peripheral neuropathy?

Peripheral Nerve Stimulation (PNS) is unique because it uses electrical currents to target specific nerves, reducing pain by altering nerve signal transmission. Unlike other treatments, PNS can be noninvasive, using an external probe on the skin, and is often used when other treatments have failed. ^{1 3 4 5 6}

Research Team

Saba Javed, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for adults aged 18-85 with long-term pain from nerve damage caused by certain chemotherapy drugs or radiation, who have finished chemo within the last year. They must be patients at MD Anderson's Pain Management Center and report a pain level of 4 or higher on a scale to 10. People with cognitive issues, recent substance abuse, skin infections, allergies to specific medical materials, pregnancy, or conditions conflicting with the PNS device can't join.

Inclusion Criteria

I have long-term nerve pain in my legs due to cancer treatment.

My pain level is 4 or higher on a scale of 0 to 10.

I finished my chemotherapy less than a year ago.

Exclusion Criteria

Participants with recent history (<6 months) of drug or alcohol abuse

Participants with cognitive dysfunction

Participants with allergies to local anesthesia, steroids, or adhesives

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive peripheral nerve stimulation (PNS) with leads inserted via a needle, providing a mild electrical current to the affected nerves 24 hours a day for up to 60 days

8 weeks

Regular visits during treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of pain intensity, sensory testing, gait testing, and skin punch biopsy

4 weeks

2 visits (in-person)

Long-term follow-up

Monitoring for safety and adverse events, graded according to NCI CTCAE v5.0

Up to 1 year

Treatment Details

Interventions

• Peripheral Nerve Stimulation

Trial Overview The study is testing whether Peripheral Nerve Stimulation (PNS), which involves sending electrical signals to nerves through small devices placed under the skin, can reduce pain in people suffering from chronic chemotherapy-induced peripheral neuropathy (CIPN) in their lower extremities.

Participant Groups

Group I: Peripheral Nerve Stimulation Experimental Treatment 1 Intervention

Participants will be asked to have PNS leads inserted via a needle, which will provide a mild, stimulating electrical current to the effected nerves 24 hours a day for up to 60 days. Participants will have study visits during and after this time.

Peripheral Nerve Stimulation is already approved in United States, European Union for the following indications:

Approved in United States as PNS for:

• Chronic knee pain
• Postoperative knee pain
• Osteoarthritis-related knee pain

Approved in European Union as PNS for:

• Chronic knee pain
• Postoperative knee pain
• Neuropathic pain

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Findings from Research

Peripheral nerve stimulation (PNS) is an advanced treatment option for patients with peripheral neuropathic pain, particularly when other treatments have failed, highlighting its role as a specialized analgesic technique.

In a reported case of intractable neuropathic pain after multiple surgeries, PNS provided significant pain relief after previous treatments were ineffective, demonstrating its efficacy in managing chronic pain conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peripheral nerve stimulation in intractable neuropathic pain. Kozak, J., Kobesova, A., Vrba, I., et al.[2013]

Ultrasound-guided placement of peripheral nerve stimulation electrodes in cadaver specimens showed no gross nerve damage and allowed for precise positioning near the targeted nerves, indicating a safe method for potential clinical use.

Out of the three electrodes placed, only one showed significant migration after 21 hours of simulated activity, suggesting that the anchoring technology used may effectively minimize electrode movement during normal use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of ultrasound-guided percutaneous placement of peripheral nerve stimulation electrodes and anchoring during simulated movement: part two, upper extremity. Huntoon, MA., Hoelzer, BC., Burgher, AH., et al.[2019]

A case study of a 53-year-old woman with chronic lower extremity neuropathic pain showed that a design-specific peripheral nerve stimulation (PNS) device provided significant pain relief and improved functionality for two years after implantation.

This case highlights the effectiveness of modern PNS technology, suggesting it may be a preferable option over spinal cord stimulation for patients with isolated extremity pain, particularly those with spinal abnormalities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advancement in Neuromodulation Technology with the Innovation of Design-Specific Peripheral Nerve Stimulators: Sural Nerve Stimulation for Radiculopathy. Langford, B., Mauck, WD.[2021]

A new training curriculum for Peripheral Nerve Stimulation (PNS) has been developed by a multidisciplinary task force to standardize education and improve proficiency in this effective treatment for chronic pain.

The curriculum includes defined milestones for learners at different levels (early, advanced, and practitioner) and covers essential skills such as professionalism, medical knowledge, and procedural skills, ensuring comprehensive training in PNS therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Educational Curriculum for Peripheral Nerve Stimulation Developed by the North American Neuromodulation Society. Kalia, H., Abd-Elsayed, A., Malinowski, M., et al.[2023]

Peripheral nerve stimulation (PNS) is an effective technique for managing various types of chronic and acute pain by using electrical stimulation to inhibit pain signal transmission in both central and peripheral pathways.

PNS works by inhibiting specific pain fibers in the central nervous system and downregulating inflammatory mediators and neurotransmitters involved in pain signaling, making it a versatile option for treating conditions like post-surgical pain, headaches, and phantom limb pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanism of Action of Temporary Peripheral Nerve Stimulation. Abd-Elsayed, A., Attanti, S., Anderson, M., et al.[2023]

External noninvasive peripheral nerve stimulation (EN-PNS) showed significant short-term pain relief in patients with refractory neuropathic pain, with an average reduction of 2.8 points on a numerical rating scale after treatment.

In a study of 20 patients, 40% experienced improvements in quality of life and function, indicating that EN-PNS may be a beneficial option for managing chronic pain, although further controlled studies are needed to validate these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

External Noninvasive Peripheral Nerve Stimulation Treatment of Neuropathic Pain: A Prospective Audit. Johnson, S., Ayling, H., Sharma, M., et al.[2022]

References

1. Sweden pubmed.ncbi.nlm.nih.gov

Peripheral nerve stimulation in intractable neuropathic pain. [2013]

2. England pubmed.ncbi.nlm.nih.gov

Feasibility of ultrasound-guided percutaneous placement of peripheral nerve stimulation electrodes and anchoring during simulated movement: part two, upper extremity. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Advancement in Neuromodulation Technology with the Innovation of Design-Specific Peripheral Nerve Stimulators: Sural Nerve Stimulation for Radiculopathy. [2021]

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

Educational Curriculum for Peripheral Nerve Stimulation Developed by the North American Neuromodulation Society. [2023]

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

Mechanism of Action of Temporary Peripheral Nerve Stimulation. [2023]

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

External Noninvasive Peripheral Nerve Stimulation Treatment of Neuropathic Pain: A Prospective Audit. [2022]