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

12 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Epidural Stimulation for spinal cord injury?

Research shows that epidural electrical stimulation can help people with severe spinal cord injuries regain some motor functions, like standing and making step-like movements. In some cases, it has also been effective in managing chronic pain and enabling voluntary muscle control, suggesting it could be a promising treatment for improving movement and reducing pain in these patients. ^{1 2 3 4 5}

Is epidural electrical stimulation safe for humans?

Epidural electrical stimulation (EES) has been used for decades and is FDA approved, indicating it is generally considered safe for humans. However, there can be complications such as excessive spread of stimulation current, which may activate non-target muscles. ^{1 6 7 8 9}

How is the treatment Epidural Stimulation unique for spinal cord injury?

Epidural Stimulation is unique because it involves applying electrical currents directly to the spinal cord to help restore movement and function in people with spinal cord injuries. Unlike other treatments, it targets the spinal circuits responsible for movement, potentially enabling standing and stepping even in cases of severe paralysis. ^{1 2 5 7 10}

What is the purpose of this trial?

This study is designed to assess the strategy of using spinal cord stimulation to improve the ability to move in spinal cord injured humans.

Research Team

Daniel C Lu, MD PhD

Principal Investigator

University of California, Los Angeles

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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 (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 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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Epidural electrical stimulation to facilitate locomotor recovery after spinal cord injury. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Experience with spinal cord stimulation (SCS) in the management of chronic pain in a traumatic transverse lesion syndrome. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Enabling Task-Specific Volitional Motor Functions via Spinal Cord Neuromodulation in a Human With Paraplegia. [2017]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Transcutaneous Spinal Cord Stimulation: Advances in an Emerging Non-Invasive Strategy for Neuromodulation. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Epidural spinal cord stimulation as an intervention for motor recovery after motor complete spinal cord injury. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Characterization and applications of evoked responses during epidural electrical stimulation. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Epidural stimulation: comparison of the spinal circuits that generate and control locomotion in rats, cats and humans. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Epidural combined optical and electrical stimulation induces high-specificity activation of target muscles in spinal cord injured rats. [2023]

9. Austria pubmed.ncbi.nlm.nih.gov

[Epidural spinal electrostimulation (ESES) in patients with chronic pain and central motor disturbances (author's transl)]. [2006]

10. United States 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. [2020]