Neuromodulation for Peripheral Neuropathy

Overseen By Saba Javed, M D

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: Unknown

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether neuromodulation can ease pain for individuals with CIPN, a condition affecting nerves in the legs and feet. Neuromodulation uses devices to alter nerve signal transmission, potentially reducing pain. The trial includes two groups: one receives neuromodulation treatment with devices like the Abbott® DRG or Medtronic® SCS systems, while the other does not. Eligible participants are patients with nerve pain in their lower limbs due to specific chemotherapy drugs, treated at the Pain Management Center at MD Anderson Cancer Center. As an unphased trial, this study provides an opportunity to explore innovative pain management techniques.

Do I need to stop my current medications for the trial?

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 neuromodulation is safe for treating peripheral neuropathy?

Research has shown that the Abbott and Medtronic systems, which include treatments like DRG (dorsal root ganglion) and SCS (spinal cord stimulation), help manage chronic pain in the body and limbs. Patients usually tolerate these treatments well. A safety review found that these devices effectively reduce pain, especially nerve pain after surgery. However, they should not be used in individuals with certain risks, such as multiple health issues or ongoing infections.

The Abbott SCS system has already received approval for treating diabetic nerve pain, indicating it has passed safety checks for that condition. This approval enhances confidence in its safety. While risks exist, as with any medical procedure, these devices have a history of being safe and effective for similar types of pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about neuromodulation techniques like Abbott® DRG and Abbott®/Medtronic® SCS for treating peripheral neuropathy because they offer a novel approach that directly targets the nervous system. Unlike traditional treatments that mainly focus on relieving symptoms with medications such as painkillers or antidepressants, these neuromodulation devices aim to modify nerve activity to alleviate pain. This can potentially provide more effective and longer-lasting relief. Additionally, neuromodulation offers a non-drug alternative, which is appealing for patients seeking to minimize medication use and its associated side effects.

What evidence suggests that neuromodulation is effective for peripheral neuropathy?

This trial will compare the effectiveness of neuromodulation with a control group for treating peripheral neuropathy. Research has shown that neuromodulation, which involves changing nerve activity through specific stimulation, can help treat chronic pain. Participants in the treatment group will receive neuromodulation using systems like the Abbott spinal cord stimulation (SCS) system. Studies have found this system effectively manages chronic pain in the body and limbs, providing significant relief. Evidence from several studies also supports the effectiveness of dorsal root ganglion (DRG) stimulation, another neuromodulation method, in reducing severe, long-lasting pain. The Proclaim™ DRG Therapy has proven effective for nerve pain, especially after surgery. High-frequency SCS has significantly relieved pain without causing uncomfortable sensations. These findings suggest that neuromodulation might help improve pain caused by chemotherapy-induced peripheral neuropathy (CIP). ^{1 2 3 6 7}

Who Is on the Research Team?

Saba Javed, M D

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults aged 18-85 with chemo-induced peripheral neuropathy (CIPN) from specific drugs like vinca alkaloids, taxanes, and platinum-based compounds. Participants must understand the study and consent to join. It's not for those with cognitive issues, recent substance abuse, other types of neuropathy, skin lesions or current infections.

Inclusion Criteria

Patients who have been seen at the Pain Management Center at MD Anderson Cancer Center.

I have nerve pain in my legs due to cancer treatment drugs.

Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

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

You have problems with memory or thinking.

You have used drugs or alcohol excessively in the past six months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive neuromodulation treatment to assess its effect on chemo-induced peripheral neuropathy

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Abbott® DRG / Abbott®/Medtronic® SCS
• Control Group

Trial Overview The study tests neuromodulation treatments using Abbott® DRG or Abbott®/Medtronic® SCS devices against a control group to see if they can relieve pain associated with CIPN. The effectiveness will be measured through nerve and sensory testing.

How Is the Trial Designed?

Group I: Treatment Group Experimental Treatment 1 Intervention

Group 1 will receive neuromodulation.

Group II: Control Group Experimental Treatment 1 Intervention

Group 2 will not receive neuromodulation.

Abbott® DRG / Abbott®/Medtronic® SCS is already approved in United States, European Union for the following indications:

Approved in United States as Proclaim DRG Neurostimulation System for:

• Complex Regional Pain Syndrome (CRPS)
• Causalgia - nerve pain following surgery or injury

Approved in United States as Abbott SCS System for:

• Chronic pain of the torso, arms, and legs
• Failed back surgery syndrome
• Back pain not caused or treated with surgery
• Diabetic peripheral neuropathy

Approved in European Union as Proclaim DRG Neurostimulation System for:

• Complex Regional Pain Syndrome (CRPS)

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Foundation for Anesthesia Education and Research

Collaborator

Trials

14

Recruited

34,500+

Published Research Related to This Trial

In a study of 60 diabetic patients with peripheral arterial occlusive disease, spinal cord stimulation (SCS) was highly effective in relieving pain and achieving limb salvage, particularly in patients without autonomic neuropathy, where 100% success was noted.

The presence and severity of autonomic neuropathy significantly impacted the success of SCS therapy, with 25 out of 28 patients with autonomic neuropathy experiencing treatment failure or only partial success, highlighting the importance of assessing neuropathy status before SCS intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does autonomic neuropathy influence spinal cord stimulation therapy success in diabetic patients with critical lower limb ischemia? Petrakis, IE., Sciacca, V.[2019]

Spinal cord stimulation (SCS) has shown mixed results for treating painful peripheral neuropathy, with early-stage sympathetically maintained symptoms responding better than progressive sympathetically independent symptoms.

New selective nerve root stimulation (SNRS) strategies using peripheral neurostimulation have been explored as a potential treatment for end-stage diabetic peripheral neuropathy, particularly for patients with 'dying back' symptoms that are typically harder to treat.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Selective Nerve Root Stimulation (SNRS) in the Treatment of End-Stage, Diabetic, Peripheral Neuropathy: A Case Report. Aló, KM., Zidan, AM.[2022]

Spinal cord stimulation (SCS) for refractory angina showed a significant reduction in angina attacks from baseline in both high stimulation (HS) and low stimulation (LS) groups, but there was no significant difference in effectiveness between the two groups after six months.

The study, which included 68 patients, found that the safety profile was similar for both HS and LS groups, with no significant difference in major adverse cardiac events (MACE) rates, indicating that SCS is safe but not more effective than lower stimulation levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation therapy for patients with refractory angina who are not candidates for revascularization. Zipes, DP., Svorkdal, N., Berman, D., et al.[2022]

Electric spinal cord stimulation (SCS) has been shown to effectively reduce hospital admissions and overall healthcare costs for patients with refractory angina pectoris, based on a study of 18 patients with an average age of 56.5 years.

Patients experienced significant improvements in quality of life, including pain perception and daily functioning, one year after SCS implantation, indicating that SCS is a beneficial treatment option for managing severe angina.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electric Spinal Cord Stimulation (SCS) in the Treatment of Angina Pectoris: A Cost-Utility Analysis. Rasmussen, MB., Hole, P., Andersen, C.[2022]

A multicenter study involving 76 patients demonstrated that a single probe percutaneous electrical nerve stimulation (PENS) significantly reduced chronic peripheral neuropathic pain immediately after treatment and maintained pain relief over a 6-month follow-up period.

The PENS therapy was found to be safe, with only two minor adverse events reported, confirming its feasibility and effectiveness as a minimally invasive treatment option for various types of neuropathic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Novel Mini-invasive Approach to the Treatment of Neuropathic Pain: The PENS Study. Rossi, M., DeCarolis, G., Liberatoscioli, G., et al.[2018]

Dorsal root ganglion (DRG) stimulation and spinal cord stimulation (SCS) both significantly improve quality of life for patients with complex regional pain syndrome (CRPS), with DRG providing slightly better outcomes (4.96 QALYs) compared to SCS (4.58 QALYs) over a ten-year period.

Both DRG and SCS are considered cost-effective treatments compared to comprehensive medical management (CMM), with DRG costing $34,695 per quality-adjusted life year (QALY) and SCS costing $22,084 per QALY, indicating that they offer good value for the benefits they provide.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-Effectiveness of Dorsal Root Ganglion Stimulation or Spinal Cord Stimulation for Complex Regional Pain Syndrome. Mekhail, N., Deer, TR., Poree, L., et al.[2022]

Spinal cord stimulation (SCS) has been shown to effectively reduce pain and improve quality of life in patients with ischemic heart disease (IHD) and peripheral vascular disease (PVD), without negatively impacting mortality or morbidity.

SCS can serve as an alternative treatment to surgical options like coronary artery bypass grafting (CABG) for high-risk patients, demonstrating benefits such as reduced angina frequency and intensity, increased exercise capacity, and improved circulatory indices in PVD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation for ischemic heart disease and peripheral vascular disease. De Vries, J., De Jongste, MJ., Spincemaille, G., et al.[2019]

Spinal Cord Stimulation (SCS) is increasingly used to manage severe neuropathic pain, including in rare cases like a pregnant patient with a painful thoracic arteriovenous malformation (AVM).

Using lumbar ultrasound to locate a safe site for spinal anesthesia in a patient with an SCS implant demonstrates a novel approach that can help avoid damaging the SCS electrodes during procedures like cesarean sections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Please mind the gap": successful use of ultrasound-assisted spinal anesthesia for urgent cesarean section in a patient with implanted spinal cord stimulation system for giant chest wall arteriovenous malformation - a case report. Zanfini, BA., De Martino, S., Frassanito, L., et al.[2021]

In a study of 30 patients with peripheral neuropathy who underwent spinal cord stimulation (SCS), 47% achieved long-term success in chronic pain control after an average follow-up of 87 months, indicating SCS can be an effective treatment for this condition.

Patients with causalgic and diabetic neuropathic pain experienced better outcomes with SCS, while those with postherpetic pain and intercostal neuralgia had less favorable responses, suggesting that SCS may be more beneficial for certain types of neuropathic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation for chronic pain in peripheral neuropathy. Kumar, K., Toth, C., Nath, RK.[2019]

As of 2020, there are nine commonly used spinal cord stimulator (SCS) platforms from four manufacturers, highlighting the variety of options available for chronic pain management.

Understanding the unique features and specifications of each SCS device is crucial for healthcare providers to select the most appropriate hardware for optimal patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survey of Spinal Cord Stimulation Hardware Currently Available for the Treatment of Chronic Pain in the United States. Clingan, JA., Patel, A., Maher, DP.[2022]

Spinal cord stimulation (SCS) has been shown to significantly reduce pain in patients with painful diabetic neuropathy (PDN), with low-frequency SCS providing 45% to 55% pain reduction for up to two years in small trials, and high-frequency SCS achieving 76% mean pain relief after six months in a larger study.

The studies indicated that SCS is a safe treatment option for PDN, with no unexpected safety issues reported, highlighting its potential as an effective alternative to standard pharmacological therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromodulation in the Treatment of Painful Diabetic Neuropathy: A Review of Evidence for Spinal Cord Stimulation. Strand, NH., Burkey, AR.[2022]

In a study of 402 patients with chronic pain who received spinal cord stimulation (SCS) devices, 55% of those with lower limb pain and 67% with upper limb pain reported a significant reduction in pain (≥50% reduction) after 2 years, indicating the long-term effectiveness of SCS.

The majority of patients (91%) were satisfied with their treatment, and 93% would choose to undergo the procedure again, while also showing a significant decrease in the need for pain medications, highlighting both the efficacy and safety of SCS therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation for chronic refractory pain: Long-term effectiveness and safety data from a multicentre registry. Brinzeu, A., Cuny, E., Fontaine, D., et al.[2019]

In a pilot study involving four patients with chronic neuropathic pain, computer tomographic (CT) techniques were successfully used to improve the positioning of peripheral nerve stimulator (PNS) leads, enhancing treatment effectiveness.

The study demonstrated that CT scans can reliably detect the position of implanted nerve electrodes in relation to neurovascular structures, suggesting they are superior to standard X-rays for monitoring lead placements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peripheral nerve stimulation: lead position monitoring by reconstruction CT angiography--a technical report. Klase, D., Bischof, A., Haendler, G., et al.[2016]

A 30-year-old woman with 7 years of refractory corneal neuropathic pain after LASIK surgery experienced significant pain relief using an intrathecal drug delivery system (IDDS) that administered bupivacaine and low-dose fentanyl.

The patient achieved over 50% pain relief for more than a year after the treatment, demonstrating the efficacy of intrathecal delivery for managing severe eye pain in selected cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful Management of Corneal Neuropathic Pain with Intrathecal Targeted Drug Delivery. Hayek, SM., Sweet, JA., Miller, JP., et al.[2022]

Citations

1. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf/P010032S191B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA ( ... The Abbott SCS System is used as an aid in the management of chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7065079/

Safety Analysis of Dorsal Root Ganglion Stimulation in the ... Stimulation of the dorsal root ganglion (DRG) in the treatment of chronic, intractable pain has shown excellent clinical results in multiple published studies.

3. neuromodulation.abbott neuromodulation.abbott/us/en/healthcare-professionals/hcp-chronic-pain/proclaim-drg-neurostimulator-system.html

Proclaim™ DRG System Proclaim™ DRG Therapy is proven effective for the following:2. Neuropathic pain after surgical procedures (causalgia):. Hernia repair; Total knee and hip ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1094715925006919

Technical and Clinical Overview: Spinal Cord Stimulation The SCS devices of all Food and Drug Administration-approved companies are reviewed, including Medtronic, Abbott, Boston Scientific, Saluda, ...

5. jamanetwork.com jamanetwork.com/journals/jamaneurology/fullarticle/2777806

Effect of High-frequency (10-kHz) Spinal Cord Stimulation ... Observational data suggest high-frequency (10-kHz) SCS provides substantial pain relief for patients with PDN without generating paresthesias ...

6. neuromodulation.abbott neuromodulation.abbott/us/en/important-safety-information.html

Important Safety Information Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections.

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf/P010032S189B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) The primary benefit of the Abbott SCS system is the improvement in pain for diabetic peripheral neuropathy (DPN). The patients have exhausted most other ...