Epidural Stimulation for Spinal Cord Injury

(LTO Trial)

Overseen By Study Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Must not be taking: Opioids, Botox

Disqualifiers: Mental illness, Pregnancy, 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: 2

Duration: 10 years

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how epidural spinal cord stimulation can help individuals with long-term spinal cord injuries improve independent movement. The therapy uses a device that sends small electrical signals to the spine. The goal is to determine if this can enhance movement for those with stable spinal cord injuries below the neck. Suitable candidates have had a spinal cord injury for over a year, are not on a ventilator, and already have a well-functioning spinal cord stimulator implanted. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance mobility 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 participate if you need opioid pain medications or have used Botox in the last six months.

What prior data suggests that epidural spinal cord stimulation is safe for spinal cord injury patients?

Research has shown that epidural spinal cord stimulation is safe for people with spinal cord injuries. One study found that many patients tolerated the treatment well, with most not experiencing serious side effects. Another review confirmed this, noting that the treatment can be easily adjusted and does not harm the body.

In summary, research suggests that this type of stimulation is generally safe for those with spinal cord injuries. Serious side effects are rare, making it a promising option for people considering this treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about epidural spinal cord stimulation for spinal cord injury because it offers a new approach to restoring voluntary movement. Unlike traditional treatments that mainly focus on rehabilitation exercises and medication to manage symptoms, this technique directly stimulates the spinal cord with electrical impulses. This stimulation can potentially enhance voluntary muscle control by reactivating neural pathways that were previously thought to be dormant. This innovative method could provide hope for improved mobility and independence in individuals with spinal cord injuries, setting it apart from standard care options.

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

Research has shown that epidural spinal cord stimulation, which participants in this trial will receive, can significantly improve movement in people with spinal cord injuries. In one study, 44% of patients could either walk or stand with assistance or independently. Additionally, 87% of participants experienced improved overall movement. These findings offer strong hope for enhancing mobility in individuals with long-term spinal cord injuries. Further studies aim to improve these results, but the early findings are promising. ^{1 2 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 spinal cord injuries, who are not ventilator-dependent and have an existing, working FDA-approved spinal cord stimulator. They should be medically stable and at least a year out from their initial injury. Those with certain levels of impairment (AISA 'A' or 'B'), no recent Botox treatments, and not on opioid pain meds that would limit rehab participation can join.

Inclusion Criteria

My spinal injury is severe, with no or partial sensory function, without using a spinal cord stimulator.

Able to undergo the informed consent process

Medically stable in the judgment of the Principal investigator

Exclusion Criteria

Clinically significant mental illness in the judgment of the principal investigator

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

Nonfunctional spinal cord stimulator or near end-of-life, determined by the PI

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive chronic spinal cord stimulation to restore volitional movement

10 years

2 visits per year (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Epidural Spinal Cord Stimulation

Trial Overview The study tests the long-term effects of chronic epidural spinal cord stimulation in restoring voluntary movement in patients with chronic spinal cord injuries. It aims to understand how this treatment helps over time.

How Is the Trial Designed?

Group I: Volitional EMG power Experimental Treatment 1 Intervention

Assessing the change in volitional EMG power during the Brain Motor Control Assement (BMCA) between nonstimulation baseline and 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+

Published Research Related to This Trial

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 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 stimulation has evolved from primarily suppressing pain in spinal cord injury patients to facilitating posture and locomotion, showing promise in helping individuals with severe spinal cord injuries regain movement.

Research indicates that the lumbosacral region of the spinal cord contains the necessary circuitry for normal locomotion, and combining epidural stimulation with pharmacological treatments and step training enhances locomotor patterns, suggesting a potential pathway for rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epidural stimulation: comparison of the spinal circuits that generate and control locomotion in rats, cats and humans. Gerasimenko, Y., Roy, RR., Edgerton, VR.[2022]

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]

In a study of 35 patients who underwent spinal cord stimulator (SCS) paddle removal, the procedure was performed safely with a low complication rate, reporting only two cases of superficial infections that were easily treated with antibiotics.

The use of neuromonitoring and fluoroscopy during the procedure contributed to the minimal risk, demonstrating that SCS paddle removal can be effectively managed with careful surgical techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Techniques for Safe Removal of Spinal Cord Stimulation Paddle Leads. Topp, G., Harland, T., Spurgas, M., 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]

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]

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]

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]

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 involving seven patients with traumatic paraplegia and chronic pain, six patients reported good to very good outcomes from epidural electrical stimulation over follow-up periods of up to six years.

The positive effects on chronic pain suggest that epidural electrical stimulation should be considered as a treatment option before resorting to more invasive surgical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experience with spinal cord stimulation (SCS) in the management of chronic pain in a traumatic transverse lesion syndrome. Buchhaas, U., Koulousakis, A., Nittner, K.[2019]

Spinal cord epidural stimulation (SCES) not only aids in facilitating walking but also improves cardiovascular autonomic regulation and reduces spasticity in a 27-year-old male with a complete spinal cord injury, as shown in assessments conducted 15 weeks apart.

The study demonstrated that SCES can stabilize blood pressure during postural changes and significantly reduce muscle spasticity, suggesting that a single SCES configuration can provide multiple functional benefits, which may enhance its clinical application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of percutaneously-implanted epidural stimulation on cardiovascular autonomic function and spasticity after complete spinal cord injury: A case report. Gorgey, AS., Goldsmith, J., Alazzam, A., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10889415/

Epidural Spinal Cord Stimulation for Spinal Cord Injury in ... Results indicated significant improvements in motor function: 44% of patients achieved assisted or independent stepping or standing; 87% showed ...

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

Spinal Cord Stimulation: Clinical Efficacy and Potential ... The study is remarkable in that 81.2% of patients randomized to DRG SCS achieved success at 3 months, compared with 55.7% in those who received conventional ...

3. e-neurospine.org e-neurospine.org/journal/view.php?doi=10.14245/ns.2244652.326

A Review of Functional Restoration From Spinal Cord ... This review aims to assess the efficacy of spinal cord stimulation, both epidural (eSCS) and transcutaneous (tSCS), on the return of function in individuals ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0014488625001943

Recent advances in potential mechanisms of epidural ... Epidural spinal cord stimulation shows promise in enhancing motor function and promoting neuroplasticity, but further research is needed to optimize treatment ...

5. neurolrespract.biomedcentral.com neurolrespract.biomedcentral.com/articles/10.1186/s42466-023-00241-z

Beyond treatment of chronic pain: a scoping review about ... Epidural electrical epinal cord stimulation (ESCS) is an established therapeutic option in various chronic pain conditions.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06867809

NCT06867809 | Spine and Brain Stimulation for Movement ... Stimulation of the spinal cord and brain represents a new experimental therapy that may have potential to restore movement after spinal cord injury.

7. sciencedirect.com sciencedirect.com/science/article/pii/S1878747923005755

Review article Spinal Cord Stimulation: An Update Spinal cord stimulation (SCS) is an adjustable, nondestructive, neuromodulatory procedure that delivers therapeutic doses of electrical current to the spinal ...

8. nature.com nature.com/articles/s41591-024-02940-9

Non-invasive spinal cord electrical stimulation for arm and ... These results demonstrate the safety and efficacy of ARC EX Therapy to improve hand and arm functions in people living with cervical SCI.