Spinal Cord Epidural Stimulation for Spinal Cord Injury

Overseen By Charles Hubscher, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Louisville

Disqualifiers: Botox injections, Bladder surgery, Colostomy, Ventilator, 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: 80

Duration: 6 months

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores spinal cord epidural stimulation to help individuals with spinal cord injuries manage blood pressure and heart rate during bladder and bowel activities. Researchers aim to determine how this stimulation can improve daily life by reducing episodes of autonomic dysreflexia, a condition that causes sudden high blood pressure when the bladder fills or during bowel movements. The trial consists of two main parts: one measures symptoms during bladder and bowel activity, and the other tests the stimulation treatment to regulate cardiovascular function. Suitable participants have neurogenic bladder and bowel issues and use a catheter for bladder emptying. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance the quality of life for many.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have an implanted pump, you would not be eligible to participate.

What prior data suggests that spinal cord epidural stimulation is safe for regulating cardiovascular function in spinal cord injury patients?

Research has shown that spinal cord epidural stimulation has been studied for safety in people with spinal cord injuries. In previous studies, some participants experienced side effects such as the device moving from its original position, infections, and sudden changes in blood pressure. However, these side effects were uncommon.

Prospective trial participants should know that while the treatment appears promising, it carries some risks. Fortunately, these issues occur infrequently. Discussing potential implications with a doctor is essential. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about spinal cord epidural stimulation because it offers a new way to manage autonomic dysreflexia in individuals with spinal cord injuries. Unlike current treatments that mainly involve medications to control blood pressure, this technique directly stimulates the spinal cord to maintain stable blood pressure and heart rate during bladder and bowel activities. This method not only targets the issue more directly but also provides the potential for patients to manage their symptoms at home, enhancing their independence and quality of life.

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

Research has shown that spinal cord epidural stimulation (eSCS) holds promise for people with spinal cord injuries. In this trial, one group will use eSCS to maintain blood pressure and heart rate during activities like bladder filling and bowel movements, which are critical since spinal cord injuries can affect these vital functions. Studies have found that eSCS can help control these functions. Evidence also suggests that eSCS may improve movement and assist the brain in forming new connections. Overall, the data suggests that eSCS could effectively manage heart and blood pressure issues related to spinal cord injuries. ^{3 6 7 8 9}

Who Is on the Research Team?

Charles Hubscher, PhD

Principal Investigator

University of Louisville

Are You a Good Fit for This Trial?

This trial is for adults with spinal cord injuries who have issues with bladder and bowel control. Participants must use intermittent catheterization and not be pregnant, ventilator-dependent, or have a colostomy bag. They shouldn't have had certain bladder treatments like Botox injections or surgery.

Inclusion Criteria

You have had a Medtronic scES array implanted before.

I have issues controlling my bladder and bowel due to nerve problems.

I use a catheter sometimes to help empty my bladder.

Exclusion Criteria

You need to use a ventilator to help you breathe for Arms 1 and 2.

I have had Botox injections in my bladder or bladder surgery before.

Arms 1 and 2: Pregnant at the time of enrollment or planning to become pregnant during the time course of the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo spinal cord epidural stimulation for maintenance of blood pressure and heart rate during bladder and bowel management

6 months

80 sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Spinal Cord Epidural Stimulation

Trial Overview The study tests how well spinal cord epidural stimulation can manage high blood pressure and improve bladder and sexual function after injury. It involves controlled lab assessments and at-home monitoring to evaluate the therapy's effectiveness.

How Is the Trial Designed?

Group I: Cardiovascular spinal cord epidural stimulation Experimental Treatment 1 Intervention

The purpose of this arm is to use spinal cord epidural stimulation for maintenance of blood pressure and heart rate in the lab during cystometry (bladder filling) and anorectal filling (bowel distension) and in the at-home setting for maintenance of normative blood pressure and heart rate that can be triggered from bladder filling and during bowel evacuation.

Group II: Measure symptomatic indices of autonomic dysreflexia Active Control 1 Intervention

The purpose of this arm is to systematically measure symptomatic indices of autonomic nervous system activation and corresponding cardiovascular changes in persons with spinal cord injuries during bladder filling and bowel stimulation.

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

Approved in United States as Spinal Cord Stimulation for:

• Respiratory dysfunction in spinal cord injury
• Pain management

Approved in European Union as Epidural Spinal Cord Stimulation for:

• Chronic pain
• Respiratory complications in spinal cord injury

Approved in Canada as Electrical Spinal Cord Stimulation for:

• Spinal cord injury rehabilitation
• Neuropathic pain

Who Is Running the Clinical Trial?

University of Louisville

Lead Sponsor

Trials

353

Recruited

76,400+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

A patient experienced neurological complications, including tinnitus, vertigo, and facial twitches, after receiving a high-frequency spinal cord stimulator, which resolved upon deactivation of the device.

This case highlights the need for further research into the less common neurological side effects of spinal cord stimulation therapy, as current knowledge primarily focuses on surgical site infections and hardware issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Onset Tinnitus after High-Frequency Spinal Cord Stimulator Implantation. Golovlev, AV., Hillegass, MG.[2020]

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]

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]

Spinal cord stimulation has been effectively used for various conditions, including chronic pain syndromes, but the method has evolved from subdural to epidural placement to enhance safety and reduce surgical complications.

The review highlights potential complications from early subdural stimulation techniques, such as infection and neurotoxicity, which can inform the development of a new subdural stimulation approach aimed at improving both safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postsurgical pathologies associated with intradural electrical stimulation in the central nervous system: design implications for a new clinical device. Gibson-Corley, KN., Flouty, O., Oya, H., 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]

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]

Epidural spinal cord stimulation (ESCS) has shown potential for improving motor function in individuals with spinal cord injury, with 18 studies reviewed reporting some level of improvement in motor activity among 24 participants.

Despite the encouraging results, the overall therapeutic efficacy of ESCS remains inconclusive due to the poor quality of studies and the heterogeneity of outcome measures, which prevented a meta-analysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epidural spinal cord stimulation for motor recovery in spinal cord injury: A systematic review. McHugh, C., Taylor, C., Mockler, D., et al.[2021]

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]

Epidural spinal cord stimulation can effectively elicit spinal motor evoked potentials (sMEPs) in forelimb muscles of rats after spinal cord injury, with the strength of these responses varying based on electrode placement and stimulation intensity.

sMEPs can serve as reliable biomarkers to optimize stimulation parameters for improving forelimb motor function, suggesting a more efficient method for determining effective treatment configurations compared to traditional empirical testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of optimal electrode configurations for epidural spinal cord stimulation in cervical spinal cord injured rats. Alam, M., Garcia-Alias, G., Shah, PK., et al.[2018]

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]

A 25-year-old male with penetrating spinal cord injury from a gunshot wound regained partial voluntary movement and improved bowel function after receiving epidural spinal cord stimulation (eSCS).

This case suggests that eSCS may be a promising intervention for enhancing recovery in patients with penetrating spinal cord injuries, which has been less studied compared to nonpenetrating injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recovery of volitional movement with epidural stimulation after "complete" spinal cord injury due to gunshot: A case report and literature review. Gupta, R., Johnson, R., Samadani, U.[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]

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]

Citations

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

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

2. 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 ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35851008/

Effect of epidural spinal cord stimulation after chronic ... The aim of this study is to assess the effects of tonic eSCS after chronic SCI on quantitative outcomes of volitional movement and cardiovascular function.

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. clinicaltrials.gov clinicaltrials.gov/study/NCT07042815?aggFilters=status%3A

Long-term Follow-up for Epidural Stimulation in SCI The goal of this study is to understand long-term effects of spinal cord stimulation in individuals who have a spinal cord injury.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38398403/

Epidural Spinal Cord Stimulation for Spinal Cord Injury in ... Notable adverse effects included device migration, infections, and post-implant autonomic dysreflexia, although these were infrequent. (4) ...

7. mdpi.com mdpi.com/2077-0383/13/4/1090

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

8. clinicaltrials.gov clinicaltrials.gov/study/NCT02592668

NCT02592668 | Spinal Cord Injury Epidural Stimulation This is a feasibility study to test the use of epidural stimulation to restore volitional function previously lost due to spinal cord injury.

9. nature.com nature.com/articles/s41467-023-37845-7

A case study of percutaneous epidural stimulation to ... Spinal cord epidural stimulation (SCES) may modulate spinal cord neural networks to enhance multiple functions after motor complete spinal cord ...