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

Trial Summary

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 data supports the effectiveness of the treatment Spinal cord stimulator implant for Peripheral Neuropathy?

Research shows that spinal cord stimulation (SCS) can effectively reduce pain in people with peripheral neuropathy, including those with diabetic neuropathy and chemotherapy-induced neuropathy. Studies have found that SCS not only helps in pain relief but also improves quality of life and reduces the need for pain medications. ^{1 2 3 4 5}

Is spinal cord stimulation safe for treating peripheral neuropathy?

Spinal cord stimulation (SCS) is generally considered safe, with a low rate of serious side effects. In a large study, less than 1% of patients experienced serious issues like infections at the implant site, and some patients reported gastrointestinal symptoms. Overall, SCS has a high level of safety for treating chronic pain. ^{1 5 6 7 8}

How is spinal cord stimulation different from other treatments for peripheral neuropathy?

Spinal cord stimulation (SCS) is unique because it uses electrical impulses to alter nerve activity and reduce pain, which is different from conventional treatments that often rely on medications with side effects. It is particularly effective for patients whose pain does not respond to standard medical treatments. ^{1 3 4 9 10}

What is the purpose of this trial?

To explore the benefits of using closed loop spinal cord stimulation (SCS) in the treatment of patients experiencing painful chemotherapy induced peripheral neuropathy (CIPN) by assessing changes in pain, quality of life, pain medication use, sensory improvement through quantitative sensory testing, and improvement of gait through quantitative gait testing.

Research Team

Matthew Chung, MD

Principal Investigator

The University of Texas MD Anderson Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

References

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

Efficacy of spinal cord stimulators in treating peripheral neuropathy: a case series. [2022]

2. Ireland 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. [2023]

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

Treatment of pain in length-dependent peripheral neuropathy with the use of spinal cord stimulation: a systematic review. [2023]

4. Netherlands 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. [2023]

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

Spinal cord stimulation relieves chemotherapy-induced pain: a clinical case report. [2019]

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. England pubmed.ncbi.nlm.nih.gov

Long-term safety of spinal cord stimulation systems in a prospective, global registry of patients with chronic pain. [2023]

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

Gastrointestinal symptoms secondary to implanted spinal cord stimulators. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Electrical spinal-cord stimulation for painful diabetic peripheral neuropathy. [2015]

10. England pubmed.ncbi.nlm.nih.gov

High-frequency spinal cord stimulation (10 kHz) alters sensory function and nerve fiber density in painful diabetic neuropathy: a pilot prospective open-label study. [2023]