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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether peripheral nerve stimulation (PNS) can reduce pain in individuals with chronic peripheral neuropathy caused by certain cancer treatments. PNS involves placing small leads near affected nerves to deliver a gentle electrical current continuously for up to 60 days. This trial may suit individuals who have experienced ongoing lower body pain for at least 90 days following specific chemotherapy treatments. Participants will attend regular study visits during and after the treatment period. As an unphased trial, this study offers patients the chance to contribute to innovative research that could lead to new pain management options.

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 prior data suggests that peripheral nerve stimulation is safe for treating peripheral neuropathy?

Research has shown that peripheral nerve stimulation (PNS) is generally safe for people. In studies, patients experienced significant long-term pain relief from PNS, whether using temporary or permanent systems.

Reports indicate that PNS can alleviate pain without causing major side effects, making it a well-tolerated option for many. A meta-analysis, which combined data from multiple studies, found that about 61% of people responded well to this treatment.

Overall, PNS has been successfully used for various types of pain, including post-surgical pain. These findings suggest that PNS is a promising and safe option for pain relief. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Peripheral Nerve Stimulation (PNS) is unique because it offers a non-drug approach to managing peripheral neuropathy, which is often treated with medications like pain relievers, anticonvulsants, or antidepressants. Unlike these treatments, PNS involves inserting leads near the affected nerves to deliver a mild electrical current, potentially reducing pain and improving nerve function directly at the source. This method is exciting for researchers because it could offer continuous relief without the side effects associated with long-term medication use. Additionally, PNS has the potential to provide sustained benefits even after the treatment period ends, offering a promising alternative for those seeking non-pharmacological solutions.

What evidence suggests that peripheral nerve stimulation is effective for improving pain in CIPN?

Research has shown that Peripheral Nerve Stimulation (PNS) can reduce pain in individuals with nerve-related conditions. One study demonstrated that patients experienced long-term pain relief after using PNS, whether for just 60 days or with a permanent implant. Another study found that PNS not only lowered pain levels but also reduced the need for opioid painkillers and improved patients' ability to function over six months. A review of several studies found that about 61% of people experienced pain relief with PNS. Overall, PNS is considered a promising method for managing pain and offers an alternative to medications like opioids. Participants in this trial will receive PNS for up to 60 days to evaluate its effectiveness in managing peripheral neuropathy. ^{1 2 3 6 7}

Who Is on the Research Team?

Saba Javed, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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

I have an open skin wound or am on antibiotics for an infection.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11801347/

Real-world long-term outcomes of peripheral nerve stimulation Patients report clinically meaningful long-term pain relief after receiving PNS through both 60-day and permanent implant systems.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33222402/

Peripheral Nerve Stimulation and Clinical Outcomes - PubMed Peripheral nerve stimulation was associated with reduced pain scores, lower opioid utilization, and improved patient function at 6 months. These data ...

3. link.springer.com link.springer.com/article/10.1007/s40122-024-00659-6

Peripheral Nerve Stimulation for Neuropathic Pain ... The meta-analysis found an estimated response rate of 61.30% (95% confidence interval 44.40–75.90%, I2 = 70.73%, p < 0.0001) to neuromodulation ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1094715925001382

Safety and Efficacy of Magnetic Peripheral Nerve ... The primary efficacy end point was a ≥50% reduction in diabetic neuropathy pain intensity at day 30, with no increase in baseline pain ...

5. tandfonline.com tandfonline.com/doi/full/10.1080/17581869.2025.2488244

Peripheral nerve stimulation: recent advances and future ... Peripheral Nerve Stimulation is an effective and evolving method of pain management, providing an alternative to opioid-based therapies and improving quality of ...

6. dovepress.com dovepress.com/efficacy-and-safety-of-magnetic-peripheral-nerve-stimulation-for-treat-peer-reviewed-fulltext-article-JPR

Efficacy and Safety of Magnetic Peripheral Nerve ... Efficacy and Safety of Magnetic Peripheral Nerve Stimulation for Treatment of Neuropathic Pain; One Year Follow Up of Long-Term Outcomes.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8586305/

Peripheral Nerve Stimulation: A Review of Techniques and ... Multiple studies have shown success in the use of peripheral nerve stimulation for acute post-surgical pain for orthopedic surgery.