Spinal Cord Stimulation for Peripheral Neuropathy

Overseen By Matthew Chung, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Antibiotics, Investigational agents

Disqualifiers: Active chemotherapy, Brain metastases, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 1 year

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether spinal cord stimulation, a device implanted to send electrical signals, can reduce pain and improve quality of life for individuals with painful peripheral neuropathy caused by chemotherapy. Researchers aim to determine if this treatment can lessen pain, enhance sensory response, and assist with walking. Individuals who have undergone chemotherapy and experience nerve pain in their legs may be suitable candidates.

As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could enhance future treatment options.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, you cannot participate if you are undergoing active chemotherapy, immunotherapy, or taking investigational agents.

What prior data suggests that this spinal cord stimulator implant is safe for treating painful chemotherapy induced peripheral neuropathy?

Studies have shown that spinal cord stimulation (SCS) can be a relatively safe method for managing chronic pain. One study found that SCS effectively reduced pain over the long term, indicating good patient tolerance. However, some risks exist. Another analysis reported 520 issues related to SCS, with most being serious and a few life-threatening.

Participants must understand both the benefits and risks before deciding to join a trial. Consulting healthcare professionals is crucial for gaining a clear understanding of what to expect. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Spinal cord stimulation (SCS) is unique because it offers a new approach to managing peripheral neuropathy, particularly when compared to standard treatments like medications and physical therapy. While most treatments focus on symptom relief through drugs like gabapentin or duloxetine, SCS works by directly modulating nerve signals in the spinal cord, potentially providing more targeted and effective pain relief. Researchers are excited about SCS because it addresses chronic pain at its source and may offer longer-lasting relief without the side effects commonly associated with medication.

What evidence suggests that spinal cord stimulation is effective for peripheral neuropathy?

Research has shown that spinal cord stimulation (SCS), which participants in this trial will receive, can help manage chronic pain. One study found that 83% of patients experienced significant pain relief with high-frequency SCS. Another study reported that 75% of people with back pain improved within six months of using this treatment, and 80% continued to benefit after three years. SCS has also successfully treated painful diabetic nerve damage, with 59% of patients noticing improvements. While these results are encouraging, individual experiences may vary. ^{4 5 6 7 8}

Who Is on the Research Team?

Matthew Chung, MD

Principal Investigator

The University of Texas MD Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals suffering from painful peripheral neuropathy caused by chemotherapy. Participants should have a history of cancer treatment-related nerve pain in their limbs and be seeking relief.

Inclusion Criteria

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

I have another cancer, but it won't affect this treatment's safety or results.

I have nerve damage in my legs due to chemotherapy.

Exclusion Criteria

I am currently being treated with antibiotics for an active infection.

Patients undergoing medical litigation

Patients that are pregnant or planning to conceive

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Weekly visits in the Pain Management Clinic

Treatment

Participants receive closed loop spinal cord stimulation (SCS) for chemotherapy induced peripheral neuropathy

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Spinal cord stimulator implant

Trial Overview

The study tests the effectiveness of a spinal cord stimulator implant to alleviate pain, improve life quality, reduce pain medication use, enhance sensory function, and better gait in patients with chemotherapy-induced nerve damage.

How Is the Trial Designed?

Group I: SCS Implantation Experimental Treatment 1 Intervention

Participants will be screened on a weekly basis in the Pain Management Clinic

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Saluda Medical Pty Ltd

Industry Sponsor

Trials

10

Recruited

970+

Published Research Related to This Trial

In a study of 216 patients with refractory painful diabetic neuropathy, 10 kHz spinal cord stimulation (SCS) led to a remarkable 79.9% reduction in pain over 24 months, with 90.1% of participants achieving at least 50% pain relief.

The treatment also significantly improved health-related quality of life and sleep, with 65.7% of participants showing clinically meaningful neurological improvements, indicating that 10 kHz SCS is both safe and effective for long-term management of this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term efficacy of high-frequency (10 kHz) spinal cord stimulation for the treatment of painful diabetic neuropathy: 24-Month results of a randomized controlled trial. Petersen, EA., Stauss, TG., Scowcroft, JA., et al.[2023]

Spinal cord stimulation (SCS) therapy significantly reduces pain intensity in patients with length-dependent peripheral neuropathy after 12 months, based on a systematic review of 19 studies involving 376 participants.

Despite the positive findings, the quality of evidence is considered very low, indicating a need for more robust randomized controlled trials to confirm these results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of pain in length-dependent peripheral neuropathy with the use of spinal cord stimulation: a systematic review. D'Souza, RS., ElSaban, M., Martinez Alvarez, GA., et al.[2023]

Spinal cord stimulators (SCSs) have shown efficacy in treating resistant peripheral neuropathic pain, as demonstrated in three case studies involving patients with diabetes, HIV, and chemotherapy-related neuropathy.

All three patients experienced significant pain relief after SCS trials, leading to successful permanent implants in two cases, highlighting SCS as a viable option for managing chronic pain when other treatments fail.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of spinal cord stimulators in treating peripheral neuropathy: a case series. Abd-Elsayed, A., Schiavoni, N., Sachdeva, H.[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 global study involving 1881 participants, spinal cord stimulation (SCS) demonstrated a high level of safety, with a low annualized device explant rate of 3.5% and only 1.1% due to inadequate pain relief.

The most common serious adverse event was implant site infection, occurring in less than 1% of cases, indicating that SCS is generally safe for chronic pain management over a follow-up period of up to 3 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term safety of spinal cord stimulation systems in a prospective, global registry of patients with chronic pain. Rauck, RL., Loudermilk, E., Thomson, SJ., et al.[2023]

In a multicenter randomized controlled trial involving 216 participants with refractory painful diabetic neuropathy, 10-kHz spinal cord stimulation (SCS) combined with conventional medical management led to a significant mean pain relief of 74.3% after 12 months, with 85% of participants experiencing at least 50% pain relief.

The treatment also resulted in substantial improvements in health-related quality of life, with 92% of participants reporting satisfaction with the 10-kHz SCS, indicating its effectiveness and durability as a treatment option for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-Frequency 10-kHz Spinal Cord Stimulation Improves Health-Related Quality of Life in Patients With Refractory Painful Diabetic Neuropathy: 12-Month Results From a Randomized Controlled Trial. Petersen, EA., Stauss, TG., Scowcroft, JA., et al.[2023]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6391880/

Spinal Cord Stimulation: Clinical Efficacy and Potential ...

In the conventional SCS arm of the SENZA RCT, 55.5% of patients were found to have a successful outcome, a value similar to that seen in older studies (for ...

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sciencedirect.com

sciencedirect.com/science/article/pii/S016882272300517X

Real world outcomes with spinal cord stimulation

Among patients enrolled in this trial 83% achieved successful pain relief when treated with high frequency SCS, with one patient dropping out of the study due ...

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jamanetwork.com

jamanetwork.com/journals/jamaneurology/fullarticle/2777806

Effect of High-frequency (10-kHz) Spinal Cord Stimulation ...

Nonsurgical patients with refractory back pain treated with 10-kHz SCS resulted in 75% responders at 6 months and 80% at 36 months. Two prior ...

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neuromodulationjournal.org

neuromodulationjournal.org/article/S1094-7159(22)01403-9/fulltext

Long-Term Evaluation of Spinal Cord Stimulation in ...

This study aimed to evaluate the long-term effects of spinal cord stimulation (SCS) in patients with painful diabetic polyneuropathy (PDPN).

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diabetesjournals.org

diabetesjournals.org/care/article/37/11/3016/29087/Spinal-Cord-Stimulation-and-Pain-Relief-in-Painful

Spinal Cord Stimulation and Pain Relief in Painful Diabetic ...

Treatment success was shown in 59% of patients with PDPN who were treated with SCS over a 6-month period, although this treatment is not without risks.

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9329040/

Spinal Cord Stimulators: An Analysis of the Adverse Events ...

Five hundred twenty adverse events were reported for spinal cord stimulators. Most events were rated as severe (79%) or life-threatening (13%).

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accessdata.fda.gov/cdrh_docs/pdf3/P030017S357B.pdf

FDA - Summary of Safety and Effectiveness Data (SSED)

The following patients are contraindicated from being treated with Boston Scientific. Spinal Cord Stimulator Systems: • Poor surgical candidates;. • Unable to ...

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Spinal cord stimulation and pain relief in painful diabetic peripheral neuropathy: a prospective two-center randomized controlled trial.