Spinal Cord Stimulation for Peripheral Neuropathy

Overseen By Alexander Price

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University

Must be taking: Gabapentin, Pregabalin

Disqualifiers: Severe comorbidities, Spinal disease, Coagulopathy, Hemoglobin A1c > 10, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 18 months

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of spinal cord stimulation (SCS) for individuals with diabetic peripheral neuropathy, which causes persistent lower limb pain unresponsive to common pain medications like gabapentin. Participants will be randomly assigned to one of three groups: one will continue their usual medical care, another will receive an SCS implant with immediate activation, and the last will have the SCS implant with delayed activation. The study aims to determine if SCS can reduce pain, improve nerve activity, and benefit metabolic health. This trial suits individuals who have experienced diabetic neuropathy-related pain for at least a year without relief from standard treatments. As an unphased trial, it offers a unique opportunity to explore innovative treatments for those seeking new pain relief options.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that participants must be unable to discontinue blood thinning medications to be excluded. This suggests that some medications might need to be stopped, but it's not clear which ones.

What prior data suggests that spinal cord stimulation is safe for peripheral neuropathy?

Studies have shown that spinal cord stimulation (SCS) is generally safe for treating chronic pain. Research indicates it can effectively reduce pain over the long term. Another study described SCS as a safe and reversible option that doesn't rely on medication.

However, reports of unwanted effects exist. In one analysis, most effects were severe or life-threatening, though this is uncommon. Overall, SCS has been used safely for other conditions, suggesting it can be well-tolerated with proper care and monitoring. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about spinal cord stimulation (SCS) for peripheral neuropathy because it offers a novel approach compared to traditional treatments like medications and physical therapy. Unlike standard treatments, which primarily aim to relieve symptoms, SCS involves implanting a device that directly modulates nerve activity to reduce pain signals. This technique can provide more targeted and potentially longer-lasting pain relief. Additionally, the trial is exploring both immediate and delayed activation of the SCS, which could help optimize treatment timing for better outcomes.

What evidence suggests that this trial's treatments could be effective for peripheral neuropathy?

Research shows that spinal cord stimulation (SCS) effectively relieves pain. Studies indicate that many patients using SCS experience significant pain reduction, with up to 55.5% achieving successful results. In this trial, participants will divide into different groups: one group will receive immediate activation of the SCS, while another will have delayed activation. SCS has proven to be up to eight times more effective than standard medical treatments for managing pain. Over two years, SCS led to lasting improvements in quality of life and sleep for many patients. Additionally, real-world evidence shows that SCS helps even those who have suffered from chronic pain for years. ^{2 3 4 6 7}

Who Is on the Research Team?

Brian Dalm, MD

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

This trial is for individuals with diabetic neuropathy or peripheral neuropathy, which are conditions causing nerve pain and damage. Participants should be adults who can give informed consent and have a history of chronic pain despite treatment. They must not have any contraindications to SCS therapy.

Inclusion Criteria

I passed a brain function test before surgery.

DN4 score ≥4

I am over 18 years old.

Exclusion Criteria

Hemoglobin A1c level greater than 10

My doctor thinks my other health issues are too severe for surgery.

I have a blood clotting disorder that cannot be fixed.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized into one of three groups: two treatment groups with spinal cord stimulation (SCS) and one control group. Treatment involves immediate or delayed activation of SCS.

18 months

Follow-up

Participants are monitored for changes in neuropathic symptoms, pain levels, and quality of life using various instruments.

18 months

What Are the Treatments Tested in This Trial?

Interventions

• Spinal Cord Stimulator Implantation

Trial Overview The study tests Spinal Cord Stimulator (SCS) Implantation's effectiveness in reducing pain and improving nerve function in patients with nerve damage from diabetes or other causes. It randomly assigns participants into two treatment groups or one control group to compare outcomes.

How Is the Trial Designed?

Group I: Spinal Cord Stimulator (SCS) immediate activation. Group 2 Active Control 1 Intervention

Group II: Spinal Cord Stimulator (SCS) Delayed activation. Group 3 Active Control 1 Intervention

Group III: Conventional Medical Management (CMM). Group1 Active Control 1 Intervention

Spinal Cord Stimulator Implantation is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Spinal Cord Stimulation for:

• Chronic pain
• Failed back surgery syndrome
• Complex regional pain syndrome
• Diabetic neuropathy
• Cancer-related neuropathy
• Peripheral vascular disease
• Arachnoiditis
• Spinal cord injuries
• Post-surgical pain
• Visceral abdominal pain
• Perineal pain

Approved in European Union as Spinal Cord Stimulation for:

• Chronic pain
• Neuropathic pain
• Failed back surgery syndrome
• Complex regional pain syndrome
• Diabetic neuropathy
• Cancer-related neuropathy
• Peripheral vascular disease

Approved in Canada as Spinal Cord Stimulation for:

• Chronic pain
• Neuropathic pain
• Failed back surgery syndrome
• Complex regional pain syndrome
• Diabetic neuropathy
• Cancer-related neuropathy

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

Neuright, Inc.

Collaborator

Trials

1

Recruited

60+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

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]

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]

A review of 24 patients with spinal cord stimulators (SCS) revealed that most electrodes were correctly placed in the epidural space of the spinal canal, which is crucial for effective pain management.

However, complications such as misplaced leads, infections, and hematomas were noted, highlighting the importance of proper electrode placement to avoid ineffective treatment and adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord stimulators: typical positioning and postsurgical complications. Zan, E., Kurt, KN., Yousem, DM., et al.[2016]

Spinal cord stimulation (SCS) is an effective treatment for chronic neuropathic pain conditions like Failed Back Surgery Syndrome (FBSS) and Complex Regional Pain Syndrome (CRPS), with 40% of patients no longer needing analgesic medication after 12 months.

The study of 80 patients showed that SCS not only improved pain management but also helped 47% of unemployed patients return to work, demonstrating its significant impact on quality of life with low complication rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation for FBSS and CRPS: A review of 80 cases with on-table trial of stimulation. Gopal, H., Fitzgerald, J., McCrory, C.[2018]

A study of 1490 veterans receiving spinal cord stimulators (SCS) for chronic pain showed that those with higher pre-surgical pain scores experienced a significant reduction in pain after the procedure, indicating the efficacy of SCS in managing chronic pain.

The study also found a notable decrease in opioid use among veterans post-implant, with 92.4% using opioids before the procedure compared to 86.6% afterward, highlighting the potential of SCS to reduce reliance on opioid medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of a Large Cohort of Veterans Experiencing Musculoskeletal Disorders with Spinal Cord Stimulation in the Veterans Health Administration: Veteran Characteristics and Outcomes. Wandner, LD., Fenton, BT., Goulet, JL., et al.[2022]

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]

Spinal cord stimulation (SCS) is a promising treatment for chronic pain syndromes, showing potential benefits in managing persistent neuropathic pain and aiding ischemic wound healing.

A case study of a 59-year-old woman demonstrated successful pain relief and improved condition after SCS implantation, highlighting its efficacy in treating complex pain issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation may improve not only intractable pain but also necrotic wounds. Yılmaz, A., Yıldızgören, MT., Melek, İ., et al.[2020]

Spinal cord stimulation (SCS) can provide significant pain relief for patients with chronic neuropathic pain, but there are rare cases of allergic reactions, as seen in two patients who experienced hives and pruritus after device implantation.

The allergic reactions, although uncommon, highlight the need for further research to understand the mechanisms behind these side effects, which may include delayed hypersensitivity or contact dermatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pruritus and urticaria induced by neurostimulation: A case report and review of literature. Goel, C., Manjunath, A., Kozel, OA., 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 retrospective case series of three patients, new-onset radicular pain in the L5/S1 dermatome was observed following spinal cord stimulation (SCS) insertion, suggesting potential complications despite the procedure's overall safety.

The cases highlighted the need for careful pre-procedure MRI analysis to avoid complications related to electrode placement, as well as the importance of discussing potential neurological risks with patients during the consent process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A case series of new radicular pain following the insertion of spinal cord stimulator. Baranidharan, G., Bretherton, B., Black, S.[2023]

In a study of 8326 patients who underwent spinal cord stimulation (SCS) implantation, the overall incidence of spinal cord injury (SCI) was found to be low at 2.13%, indicating that SCS is a generally safe procedure.

There was no significant difference in the rates of SCI or spinal hematoma between patients receiving percutaneous (2.35%) and paddle (1.71%) electrode implantation, suggesting similar safety profiles for both methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Incidence of Spinal Cord Injury in Implantation of Percutaneous and Paddle Electrodes for Spinal Cord Stimulation. Petraglia, FW., Farber, SH., Gramer, R., et al.[2022]

A survey of physicians revealed that 77% use deep sedation and 45% use general anesthesia during spinal cord stimulator (SCS) placements, despite recommendations for awake patient feedback during the procedure.

Most physicians (94%) reported no complications related to general anesthesia during SCS placement, indicating a potential safety in its use, but highlighting a discrepancy with current guidelines that recommend against sedation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous Spinal Cord Stimulation Lead Placement Under Deep Sedation and General Anesthesia. Hasoon, J., Urits, I., Viswanath, O., et al.[2023]

Citations

1. 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 ...

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

Long-Term Evaluation of Spinal Cord Stimulation in ... High-quality studies followed, showing SCS to be up to eight times more effective in terms of pain relief than the best medical treatment at ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2826172

Spinal Cord Stimulation vs Medical Management for ... Analysis results suggest statistical superiority of conventional and novel SCS therapies over CMM in 5 of the 6 outcomes evaluated at 6-month ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10653578/

Real-world outcomes in spinal cord stimulation Patients treated with SCS reported a mean pain duration of 9.3 years before implantation of a permanent system. In 50% of patients, chronic back ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0168822723006289

Long-term efficacy of high-frequency (10 kHz) spinal cord ... Over 24 months, 10 kHz SCS provided durable pain relief and significant improvements in HRQoL and sleep. Furthermore, the majority of participants demonstrated ...

6. 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%).

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf/P840001S469B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA ( ... The safety and effectiveness of the Medtronic implantable neurostimulation system to treat PDN was based on clinical safety outcome data from the Medtronic ...