Epidural Stimulation for Spinal Cord Injury

Overseen By Charles Hubscher, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Louisville

Must not be taking: Bladder Botox

Disqualifiers: Depression, Drug abuse, 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: Unknown

Duration: 2 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called epidural stimulation to improve bladder function in people with spinal cord injuries. Researchers aim to find the best way to use a special device with electrodes to enhance bladder control. The trial targets individuals who have had a spinal cord injury for at least two years, are stable without heart or lung issues, and have completed the early recovery phase. Participants will receive an epidural stimulator to improve bladder control. The goal is to enhance bladder function and potentially aid in standing and walking, making life easier. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could significantly improve the quality of life for those with spinal cord injuries.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

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

Research has shown that epidural electrical stimulation (EES) could benefit people with spinal cord injuries. In studies, patients demonstrated improved movement and quality of life. For instance, one study found that a patient with an injury between the T11 and T12 vertebrae experienced less pain and improved mobility. This is encouraging because it suggests the treatment is generally well-tolerated.

However, this trial is an early-stage feasibility study, providing limited information on safety. Early trials are usually smaller and focus on understanding how treatments work rather than proving complete safety. Still, since previous studies have tested EES with positive results, it appears to be a promising option for those with spinal cord injuries. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Epidural stimulation is unique because it directly targets the spinal cord to enhance bladder control, which is often a challenge for people with spinal cord injuries. Unlike traditional treatments like medications that work systemically to manage symptoms, epidural stimulation focuses on the neural circuits involved in bladder function. Researchers are excited about this approach because it may improve both storage and voiding phases of the bladder cycle, offering a more precise and potentially more effective solution compared to current options.

What evidence suggests that epidural stimulation is effective for improving lower urinary tract function in individuals with spinal cord injury?

Research has shown that epidural stimulation, which participants in this trial will receive, can improve certain abilities in people with spinal cord injuries. Studies have found that this treatment can facilitate standing and movement. For example, one study found that participants could stand and support their weight better after receiving this stimulation. Another study showed that it improved balance when reaching for objects. Animal research also supports these findings, demonstrating recovery of movement abilities. Overall, epidural stimulation appears promising for enhancing physical abilities and functions, such as bladder control, in people with spinal cord injuries. ^{1 4 6 7 8}

Who Is on the Research Team?

Susan Harkema, PhD

Principal Investigator

University of Louisville

Are You a Good Fit for This Trial?

This trial is for individuals with stable spinal cord injuries (SCI) who are at least two years post-injury, have an implanted epidural stimulator, and show signs of recovery from spinal shock. It's not suitable for those with certain medical conditions, ongoing drug abuse, recent bladder treatments like Botox injections or surgeries that change the way urine leaves the body.

Inclusion Criteria

My heart and lung health allows me to undergo bladder training.

My spinal cord injury is classified as complete or sensory incomplete.

My spinal shock has ended, shown by muscle tone or reflexes, and I've finished standard rehab.

Exclusion Criteria

I have had surgery to redirect urine flow with or without bladder enlargement.

Clinically significant depression or ongoing drug abuse

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 receive spinal cord epidural stimulation to enhance bladder storage and voiding phases

2 years

Regular visits for stimulation adjustments and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Epidural Stimulation

Trial Overview The study tests how different settings on a 16-electrode epidural device affect bladder control in people with SCI. The goal is to find out which settings improve bladder function during storage and voiding by activating specific spinal circuits.

How Is the Trial Designed?

Group I: Bladder Mapping and Training Experimental Treatment 1 Intervention

Individuals already implanted or newly implanted with a spinal cord epidural stimulator will receive epidural stimulation targeted at enhancing both the storage and voiding phase of micturition cycle.

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

Approved in United States as Epidural Stimulation for:

• Spinal cord injury rehabilitation
• Motor function recovery
• Autonomic function recovery

Approved in Canada as Epidural Stimulation for:

• Spinal cord injury rehabilitation
• Motor function recovery
• Autonomic function recovery

Approved in European Union as Epidural Stimulation for:

• Spinal cord injury rehabilitation
• Motor function recovery
• Autonomic function recovery

Who Is Running the Clinical Trial?

University of Louisville

Lead Sponsor

Trials

353

Recruited

76,400+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

Epidural electrical stimulation of the lumbosacral spinal cord has been shown to improve locomotion and standing in various preclinical models with severe spinal cord injuries, indicating its potential as a therapeutic intervention.

The review highlights that while the stimulation shows promise, the exact mechanisms by which it enhances sensorimotor functions are still not fully understood, which poses challenges for its clinical application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epidural electrical stimulation to facilitate locomotor recovery after spinal cord injury. Audet, J., Lecomte, CG.[2022]

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 has shown promise in restoring lower extremity and neurological functions in individuals with complete spinal cord injuries, suggesting it could be a beneficial adjunct to traditional rehabilitation methods.

The mechanism of action involves stimulating large diameter dorsal root proprioceptive afferents, which can activate spinal and supraspinal networks, potentially facilitating movements like standing and stepping, and improving other sensorimotor and autonomic functions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epidural spinal cord stimulation as an intervention for motor recovery after motor complete spinal cord injury. Hachmann, JT., Yousak, A., Wallner, JJ., et al.[2023]

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 electrical stimulation (EES) of the lumbosacral spinal cord allowed a patient with chronic traumatic paraplegia to achieve significant motor control, including voluntary movement of muscles for specific tasks and rhythmic movements within just 2 weeks of therapy.

This case demonstrates the potential of EES to enable independent standing and controlled movements in patients with severe spinal cord injuries, highlighting its efficacy as a promising intervention for restoring motor function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enabling Task-Specific Volitional Motor Functions via Spinal Cord Neuromodulation in a Human With Paraplegia. Grahn, PJ., Lavrov, IA., Sayenko, DG., et al.[2017]

Epidural electrical stimulation (EES) has been used therapeutically for many years, but understanding its exact mechanism of action remains unclear; this study investigates the evoked compound action potential (ECAP) as a measure of local neural activity during EES.

The research demonstrates that the ECAP component in epidural spinal recordings can help detect lead migration, a potential complication that may affect the effectiveness of EES therapy, and shows concurrent activation of back and leg muscles during stimulation, which could inform future EES system designs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterization and applications of evoked responses during epidural electrical stimulation. Verma, N., Romanauski, B., Lam, D., et al.[2023]

Epidural spinal electrostimulation (ESES) has shown promising results in improving spinal spasticity and mobility by 20 to 30% in patients with multiple sclerosis and myelopathy, indicating its efficacy in treating severe central motor disturbances.

In addition to mobility improvements, ESES led to a complete disappearance of spastic cramps in all treated cases and significant pain relief in three patients with chronic pain, suggesting its potential as a non-surgical intervention for chronic pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Epidural spinal electrostimulation (ESES) in patients with chronic pain and central motor disturbances (author's transl)]. Klingler, D., Kepplinger, B., Gerstenbrand, F., et al.[2006]

Epidural electrical stimulation (EES) has been shown to improve motor function in patients with chronic spinal cord injury, but its effects on paravertebral muscles had not been previously recognized.

In a reported case, hypertrophy of the paravertebral muscles occurred after an electrode shift in a patient with spinal cord injury, suggesting that EES may also influence muscle growth in this area, indicating a potential new avenue for rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypertrophy of paravertebral muscles after epidural electrical stimulation shifted: A case report. Li, S., Rong, H., Hao, Z., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7710539/

Epidural Electrical Stimulation of the Lumbosacral Spinal Cord ... Epidural Electrical Stimulation of the Lumbosacral Spinal Cord Improves Trunk Stability During Seated Reaching in Two Humans With Severe ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8374568/

Epidural electrical stimulation for spinal cord injury - PMC In multiple animal models of spinal cord injury, epidural electrical stimulation of the spinal cord has demonstrated a recovery of motor function.

3. 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.

4. spj.science.org spj.science.org/doi/10.34133/cbsystems.0314

Epidural Electrical Stimulation for Functional Recovery in ... This study confirms the promising therapeutic effects of EES in SCI. EES combined with PT provides a potential approach for functional recovery in patients ...

5. tandfonline.com tandfonline.com/doi/full/10.1080/10790268.2025.2517935?src=

Spinal epidural electrical stimulation for the recovery of ... With epidural stimulation, four subjects gained better control of standing full weight bearing (without assistance). Four (80%) subjects were ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07105878

Epidural Electrical Stimulation in Spinal Cord Injury The goal of this clinical trial is to evaluate the safety and effectiveness of Epidural Electrical Stimulation (EES) in motor and sensory function ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2666634025001333

Epidural electrical stimulation facilitates motor recovery in ... In their study, a patient with T11–T12 SCI showed improved motor function, reduced pain, and enhanced quality of life. Summary. Background.

8. 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).