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

24 Participants Needed

Trial Summary

What is the purpose of this trial?

To learn if a process called neuromodulation can help to improve pain due to CIP

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 data supports the effectiveness of this treatment for peripheral neuropathy?

Spinal cord stimulation (SCS) has been shown to improve blood flow and relieve pain in diabetic patients with peripheral arterial disease, and it has been used successfully for other conditions like ischemic heart disease and peripheral vascular disease, suggesting potential benefits for peripheral neuropathy. ^{1 2 3 4 5}

Is spinal cord stimulation (SCS) safe for humans?

Spinal cord stimulation (SCS) has been used for various conditions like chronic pain and angina, and studies show it is generally safe for humans. It is a well-established therapy with long-term safety data available, indicating it is not more invasive than other common procedures like cardiac pacing. ^{6 7 8 9 10}

How is the neuromodulation treatment for peripheral neuropathy different from other treatments?

This treatment uses neuromodulation, specifically spinal cord stimulation (SCS), which is unique because it targets the nervous system directly to manage pain, unlike standard medications that often provide only modest relief. It includes both conventional low-frequency and high-frequency SCS, offering options that are either paresthesia-dependent or independent, making it a novel approach for those with chronic neuropathic pain. ^{4 11 12 13 14}

Research Team

Saba Javed, M D

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

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

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

I am between 18 and 85 years old.

Exclusion Criteria

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

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

You have problems with memory or thinking.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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 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]

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]

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]

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]

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]

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]

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]

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]

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]

References

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

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

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

Does autonomic neuropathy influence spinal cord stimulation therapy success in diabetic patients with critical lower limb ischemia? [2019]

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

Spinal cord stimulation for ischemic heart disease and peripheral vascular disease. [2019]

4. Austria pubmed.ncbi.nlm.nih.gov

Peripheral nerve stimulation: lead position monitoring by reconstruction CT angiography--a technical report. [2016]

5. England 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. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation for chronic refractory pain: Long-term effectiveness and safety data from a multicentre registry. [2019]

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

Spinal cord stimulation therapy for patients with refractory angina who are not candidates for revascularization. [2022]

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

Cost-Effectiveness of Dorsal Root Ganglion Stimulation or Spinal Cord Stimulation for Complex Regional Pain Syndrome. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Survey of Spinal Cord Stimulation Hardware Currently Available for the Treatment of Chronic Pain in the United States. [2022]

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

Electric Spinal Cord Stimulation (SCS) in the Treatment of Angina Pectoris: A Cost-Utility Analysis. [2022]

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

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

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

A Novel Mini-invasive Approach to the Treatment of Neuropathic Pain: The PENS Study. [2018]

13. England pubmed.ncbi.nlm.nih.gov

Successful Management of Corneal Neuropathic Pain with Intrathecal Targeted Drug Delivery. [2022]

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

Spinal cord stimulation for chronic pain in peripheral neuropathy. [2019]