Spinal Cord Neuromodulation for Spinal Cord Injury

Overseen By Daniel C Lu, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of California, Los Angeles

Must not be taking: Anti-spasticity, Botox

Disqualifiers: Cardiopulmonary disease, Depression, Drug abuse, 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: 24 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called epidural stimulation (also known as Epidural Electrical Stimulation or EES) to help people with spinal cord injuries improve their ability to move. The researchers aim to determine if this stimulation can enhance motor function, particularly for those with challenges in hand or arm movement. Ideal participants have had a stable spinal cord injury above the neck for at least a year and experience difficulty gripping or moving independently. Participants should not have severe heart or lung issues or be on medications that affect muscle movement. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this innovative therapy.

Will I have to stop taking my current medications?

The trial requires that you are not currently on any anti-spasticity medications. Other medications are not specifically mentioned, so it's best to discuss your current medications with the trial team.

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

Research has shown that epidural stimulation may help people with spinal cord injuries regain some movement. Studies with both animals and humans have found that this type of stimulation can help restore movement. In one study, participants with long-term spinal cord injuries improved their ability to reach while sitting. Another study found that using epidural stimulation over time improved sensation and reduced muscle stiffness, making muscles easier to move.

Regarding safety, the current phase of the trial focuses on ensuring the treatment's safety for people. Early trials often aim to confirm the absence of serious side effects. So far, results suggest that epidural stimulation is generally well-tolerated. However, since research is ongoing, some risks may not yet be fully understood. Participants should discuss any concerns with their healthcare providers. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about epidural stimulation for spinal cord injury because it offers a unique approach to improving motor function. Unlike traditional treatments that may focus on rehabilitation exercises or medications, epidural stimulation involves applying electrical currents directly to the spinal cord. This technique aims to enhance communication between the brain and body, potentially leading to improved movement and function. It's a promising avenue that could offer new hope for individuals with spinal cord injuries, as it directly targets the underlying neural pathways rather than just alleviating symptoms.

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

Studies have shown that epidural stimulation, the treatment tested in this trial, can help people with spinal cord injuries regain some movement. Research indicates that this treatment improves trunk stability, aiding balance during activities like reaching. In another study, patients who used epidural stimulation with physical therapy showed promising results in recovering their ability to move. Additionally, some individuals stood without assistance after receiving this treatment. These findings suggest that epidural stimulation could effectively restore movement lost due to spinal cord injuries. ^{2 4 6 7 8}

Who Is on the Research Team?

Daniel C Lu, MD PhD

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

This trial is for adults over 18 with non-progressive spinal cord injury above C5, at least one year post-injury. Participants should not have severe heart/lung diseases, ongoing depression or drug abuse, recent botox injections, or conditions that prevent arm movement. Pregnant women and those on anti-spasticity meds or involved in other trials are excluded.

Inclusion Criteria

I don't have bleeding disorders, heart risks, or major health issues for surgery.

My spinal cord injury is stable and located above the C5 vertebra.

I have not had any botox injections in the last six months.

Exclusion Criteria

None as long as inclusion criteria are met

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive epidural stimulation to assess improvement in motor function

24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Epidural Stimulation

Trial Overview

The study tests whether spinal cord stimulation combined with a medication called Buspirone can improve movement in people with quadriplegia due to spinal cord injury. It aims to assess the effectiveness of this neuromodulation strategy.

How Is the Trial Designed?

Group I: Stimulation Experimental Treatment 2 Interventions

Determine if epidural stimulation can improve motor function.

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 California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Published Research Related to This Trial

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 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]

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]

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 shown promise in restoring motor functions in two human subjects with complete paralysis due to spinal cord injury, enabling intentional control of step-like activity within just five days after implantation.

The study highlights the effectiveness of using EES-evoked motor responses to guide the precise positioning of electrode arrays during surgery, ensuring stable and targeted stimulation of spinal cord regions associated with lower limb movement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrophysiological Guidance of Epidural Electrode Array Implantation over the Human Lumbosacral Spinal Cord to Enable Motor Function after Chronic Paralysis. Calvert, JS., Grahn, PJ., Strommen, JA., et al.[2020]

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 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 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]

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.

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.

3.

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 ...

4.

nature.com

nature.com/articles/s41598-018-26602-2

Lumbosacral spinal cord epidural stimulation improves ...

Our objective was to investigate the efficacy of spinal cord epidural stimulation (scES) as a promising therapy to improve bladder control after SCI.

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.

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.

7.

frontiersin.org

frontiersin.org/journals/systems-neuroscience/articles/10.3389/fnsys.2020.569337/full

Epidural Electrical Stimulation of the Lumbosacral Spinal ...

We characterize the effects of ES on seated reaching performance in two participants with chronic, complete loss of motor and sensory functions below thoracic- ...

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).