Epidural Spinal Cord Stimulation for Spinal Cord Injury

(E-STAND Trial)

Overseen By David Darrow, MD MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Must not be taking: Opioids, Antiplatelets, Anticoagulants, others

Disqualifiers: Cardiopulmonary issues, Dysautonomia, Mental illness, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method of using epidural spinal cord stimulation to help individuals with spinal cord injuries regain leg movement. Researchers aim to identify the optimal settings for this treatment and determine if it also improves other functions, such as blood pressure control. Individuals with a stable paraplegia injury between the C6 and T10 vertebrae for over a year may qualify. This trial offers a chance to observe improvements in daily life for those with spinal cord injuries. As an unphased trial, it provides a unique opportunity to contribute to groundbreaking research that could enhance quality of life for many.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot take antiplatelet or anticoagulation agents around the time of surgery, and you cannot have a current or anticipated need for opioid pain medications.

What prior data suggests that this method is safe for spinal cord injury patients?

Research has shown that epidural spinal cord stimulation (eSCS) is generally safe for treating spinal cord injuries. Studies have found that this method can help people regain movement and improve functions such as blood pressure control. Most patients tolerate the treatment well, with few serious side effects reported. Some mild issues, like temporary pain or discomfort at the stimulation site, might occur, but these are usually manageable. Overall, the safety information appears promising for those considering joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Epidural Spinal Cord Stimulation is unique because it directly targets the spinal cord with electrical impulses, potentially enhancing nerve function below the site of injury. Unlike standard treatments for spinal cord injury, which often focus on managing symptoms and rehabilitation, this approach aims to stimulate the spinal cord to improve motor function and sensation. Researchers are excited about this treatment because it represents a novel way to potentially restore function and improve quality of life for those with spinal cord injuries.

What evidence suggests that epidural spinal cord stimulation is effective for spinal cord injury?

Research has shown that epidural spinal cord stimulation (eSCS), the treatment under study in this trial, offers promising results for people with spinal cord injuries. Studies have found that eSCS can help restore crucial functions like movement and blood pressure control, significantly enhancing quality of life. Another review highlighted that patients using eSCS experienced a return of function and overall improvement. These findings suggest that eSCS can help individuals with spinal cord injuries regain some control and function in their lower bodies. Overall, the evidence supports eSCS as a hopeful option for improving life after a spinal cord injury. ^{1 3 6 7 8}

Who Is on the Research Team?

David Darrow, MD MPH

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for adults over 22 with stable, motor-complete paraplegia due to spinal cord injury between C6 and T10. Participants must have had the injury for over a year, be medically stable, able to consent, and commit to all appointments. Excluded are those with certain health risks or conditions that complicate surgery or rehabilitation.

Inclusion Criteria

My reflexes below my injury site work.

Willing to attend all scheduled appointments

I have stable paralysis affecting my lower limbs.

Exclusion Criteria

I need opioids for pain or have pain that might stop me from fully joining in the rehab program.

Other conditions that would make the subject unable to participate in testing/rehabilitation in the judgement of the principal investigator

I have a spinal fracture that has not yet healed.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive epidural spinal cord stimulation to optimize parameter settings for volitional movement and autonomic function

12 months

Monthly visits for assessment and optimization

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Epidural Spinal Cord Stimulation

Trial Overview

The study tests optimizing epidural spinal cord stimulation settings to restore voluntary leg movement in people with paraplegia. It also looks at improvements in autonomic functions like blood pressure control related to spinal cord injuries.

How Is the Trial Designed?

Group I: Epidural Spinal Cord Stimulation Experimental Treatment 1 Intervention

Epidural Spinal Cord Stimulation

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

Approved in European Union as Spinal Cord Stimulation for:

• Failed back surgery syndrome
• Complex regional pain syndrome
• Chronic neuropathic pain
• Ischemic pain

Approved in United States as Spinal Cord Stimulation for:

• Failed back surgery syndrome
• Complex regional pain syndrome
• Chronic neuropathic pain
• Ischemic pain
• Diabetic neuropathy

Approved in Canada as Spinal Cord Stimulation for:

• Failed back surgery syndrome
• Complex regional pain syndrome
• Chronic neuropathic pain
• Ischemic pain

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Minnesota Office of Higher Education

Collaborator

Trials

6

Recruited

280+

Minneapolis Veterans Affairs Medical Center

Collaborator

Trials

77

Recruited

355,000+

Hennepin County Medical Center, Minneapolis

Collaborator

Trials

22

Recruited

12,300+

Hennepin Healthcare Research Institute

Collaborator

Trials

94

Recruited

77,100+

Published Research Related to This Trial

Epidural spinal cord stimulation (SCS) is an effective treatment for neuropathic pain conditions like complex regional pain syndrome and chronic radiculopathy, particularly after conservative therapies have failed.

Successful use of epidural SCS requires careful patient selection and should be part of a comprehensive treatment plan, implemented only in specialized centers to manage potential complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Epidural spinal cord stimulation for therapy of chronic pain. Summary of the S3 guidelines]. Tronnier, V., Baron, R., Birklein, F., et al.[2021]

The Aarhus Neuromodulation Database has been developed to systematically collect and analyze data on spinal cord stimulation (SCS) treatments, including key parameters like pain intensity and quality of life, which can enhance the understanding and effectiveness of SCS for chronic pain.

This database is freely accessible and designed to be adaptable for various neuromodulation treatments, making it a valuable resource for both clinicians and researchers to improve patient outcomes and advance the field.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Aarhus Neuromodulation Database. Meier, K., Nikolajsen, L., Flink, M., et al.[2022]

Spinal cord stimulation (SCS) is generally considered a safe procedure, but this report highlights four cases of neurological complications, including paraparesis, following SCS implantation, indicating that while rare, such injuries can occur.

Among the four patients, one experienced complete paraplegia, two had incomplete paraparesis, and one fully recovered, suggesting that outcomes can vary significantly and further research is needed to understand the true incidence of neurological injuries related to SCS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A report of paraparesis following spinal cord stimulator trial, implantation and revision. Smith, CC., Lin, JL., Shokat, M., et al.[2011]

Epidural electrical spinal cord stimulation (ESCS) has shown promise not only in managing chronic pain but also in partially restoring motor function and neurological recovery in patients with spinal cord injuries, particularly when combined with rehabilitative therapies.

ESCS is also being explored for treating autonomic dysfunctions, such as orthostatic hypotension, indicating its potential to become a routine therapy for various complications following spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beyond treatment of chronic pain: a scoping review about epidural electrical spinal cord stimulation to restore sensorimotor and autonomic function after spinal cord injury. Luz, A., Rupp, R., Ahmadi, R., et al.[2023]

In a study of 50 patients with lower back and/or leg pain, the novel closed-loop spinal cord stimulation (SCS) system demonstrated long-term effectiveness, with 76.9% of patients achieving at least 50% pain relief after 12 months.

The system maintained spinal cord activation within a therapeutic window for 84.9% of the time, and 68.8% of patients were able to reduce or eliminate their opioid use, highlighting both safety and efficacy in pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sustained Long-Term Outcomes With Closed-Loop Spinal Cord Stimulation: 12-Month Results of the Prospective, Multicenter, Open-Label Avalon Study. Russo, M., Brooker, C., Cousins, MJ., et al.[2021]

Percutaneous epidural stimulation for intractable pain was performed on 20 patients with no major complications, demonstrating its safety and simplicity compared to traditional methods.

The technique allowed for a trial period to assess pain relief, with 7 out of 8 patients experiencing long-term pain relief for up to 2 years, suggesting its efficacy as an alternative to dorsal column stimulator implantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous epidural stimulation of the spinal cord for relief of pain. Long-term results. Urban, BJ., Nashold, BS.[2004]

Epidural spinal cord stimulation was effective in controlling pain for 40% of the 121 patients studied, with a mean follow-up of 40 months, particularly benefiting those with pain from conditions like arachnoiditis and multiple sclerosis.

While the treatment showed promise for many, it was less effective for certain types of pain, such as that from cauda equina injury or primary bone diseases, and complications like infection and electrode issues were noted, indicating the need for careful patient selection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of chronic pain by epidural spinal cord stimulation: a 10-year experience. Kumar, K., Nath, R., Wyant, GM.[2011]

Epidural spinal cord stimulation (SCS) was successfully used to reduce neuropathic pain in a 53-year-old woman with a complete spinal cord injury, decreasing her average pain from 7/10 to 4/10 over three months.

The treatment not only lowered her overall pain intensity but also reduced the frequency and intensity of pain attacks, suggesting that SCS may be a viable option for managing pain even in patients with complete spinal cord lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful spinal cord stimulation for neuropathic below-level spinal cord injury pain following complete paraplegia: a case report. Reck, TA., Landmann, G.[2019]

In a study of 68 patients who had spinal cord stimulation paddle electrodes removed, the most common reason for removal was loss of coverage or effect (75%), indicating that while SCS is effective, it may not always provide lasting relief.

Postoperative complications occurred in 11.75% of patients, with two major complications requiring reoperation, highlighting that while SCS removal is generally safe, it does carry some risks that patients should be aware of.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rate of Complications Following Spinal Cord Stimulation Paddle Electrode Removal. Maldonado-Naranjo, AL., Frizon, LA., Sabharwal, NC., et al.[2022]

Epidural spinal cord stimulation (SCS) was tested on 18 patients with intractable pain from reflex sympathetic dystrophy (RSD), showing varying degrees of pain relief: 6 experienced good relief, 5 moderate, and 1 minimal, while 3 had no relief.

Despite some technical issues with the SCS systems, none of the patients experienced worsening neurological conditions, indicating that SCS may be a safe option for managing refractory RSD pain, though further research is needed to confirm its overall effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epidural spinal cord stimulation in the management of reflex sympathetic dystrophy. Barolat, G., Schwartzman, R., Woo, R.[2018]

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]

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]

A systematic review of 13 studies on non-dorsal column intraspinal stimulation for chronic pain relief suggests that targeting specific neuronal areas, like the cervicomedullary junction and dorsal root ganglion, may provide better pain management than conventional spinal cord stimulation.

This approach could potentially reduce unwanted side effects, such as paraesthesia in non-painful areas, indicating a promising direction for future pain treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alternate Intraspinal Targets for Spinal Cord Stimulation: A Systematic Review. Chang Chien, GC., Mekhail, N.[2022]

Citations

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This study reviews the evolving role of epidural spinal cord stimulation (eSCS) in treating chronic SCI, focusing on its efficacy and safety.

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sciencedirect.com

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Review article Spinal Cord Stimulation: An Update

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This review aims to assess the efficacy of spinal cord stimulation, both epidural (eSCS) and transcutaneous (tSCS), on the return of function in individuals ...

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frontiersin.org/journals/systems-neuroscience/articles/10.3389/fnsys.2025.1622033/full

Effect of epidural spinal cord stimulation in individuals with ...

This study provides evidence that eSCS can restore key functional capacities and significantly enhance the quality of life for individuals with sensorimotor ...

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One of the first reports of dorsal column stimulation for the treatment of pain noted no changes in touch and vibration sensation, but an increase in pain ...

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Spinal Cord Stimulation - StatPearls - NCBI Bookshelf - NIH

This technique uses pulsed electrical energy near the spinal cord to manage pain. This activity reviews the indications, contraindications, equipment, ...

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aetna.com

aetna.com/cpb/medical/data/100_199/0194.html

Spinal Cord Stimulation - Medical Clinical Policy Bulletins

In a systematic review, these investigators examined safety and outcome data on DBS and SCS for patients with orthostatic tremor. They searched PubMed and ...

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mayo.edu

mayo.edu/research/clinical-trials/cls-20167853

Spinal Cord Injury Epidural Stimulation

Epidural electrical stimulation (EES) of the spinal cord has been shown to restore function after spinal cord injury (SCI).