Epidural Electrical Stimulation for Spinal Cord Disorders

Overseen By Daniel Lu, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to improve breathing during surgery using epidural electrical stimulation (EES). This technique sends small electrical signals to the cervical spinal cord, potentially counteracting breathing problems caused by opioids. Individuals undergoing brain or spinal cord surgery who require spinal monitoring might be suitable candidates for this trial. As an unphased study, this trial provides a unique opportunity to contribute to groundbreaking research in surgical care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this technique is safe for spinal cord disorders?

Studies have shown that epidural electrical stimulation (EES) can improve movement after a spinal cord injury. Researchers have used EES on the spinal cord to help restore movement in both animals and humans.

Although specific side effects are not detailed in the provided sources, various trials have tested EES. It is generally well-tolerated, with most people not experiencing serious side effects. Some individuals might feel mild discomfort or tingling during stimulation.

Since this trial is not in an early phase, EES is considered safe enough for further testing, which can reassure potential participants about its safety. However, as with any treatment, discussing any concerns with the study team or a doctor is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Epidural Electrical Stimulation is unique because it directly targets the spinal cord with electrical impulses, aiming to restore function in individuals with spinal cord disorders. Unlike traditional treatments, which might include medication or physical therapy, this approach uses a new delivery method—implanting electrodes near the cervical spinal cord to stimulate nerve activity. Researchers are excited about this treatment because it has the potential to improve motor function and quality of life for patients who have limited options with current therapies.

What evidence suggests that Epidural Electrical Stimulation is effective for spinal cord disorders?

Studies have shown that epidural electrical stimulation (EES) can help people with spinal cord injuries regain movement. In animal studies, EES of the spinal cord helped animals recover their ability to move. One study found that a person with a spinal cord injury experienced better movement, less pain, and an improved quality of life after receiving EES. Additionally, EES has treated long-term pain and other lost functions. This evidence suggests that EES might also help with breathing problems caused by opioid overdoses by stimulating the spinal cord. Participants in this trial will receive EES to evaluate its effectiveness for spinal cord disorders. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for patients who are undergoing brain or spinal cord surgery and where monitoring of the spinal cord's activity is used. There are no specific exclusion criteria, so it appears open to all eligible surgical candidates.

Inclusion Criteria

I am having brain or spinal surgery with monitoring.

Exclusion Criteria

Not applicable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intraoperative Stimulation

Epidural Electrical Stimulation of the Cervical Spinal Cord is performed during surgery to assess effects on respiratory function

During surgery

1 visit (in-person)

Follow-up

Participants are monitored for changes in heart rate, blood pressure, respiratory frequency, and tidal volume after stimulation

Within 2 minutes after stimulation

What Are the Treatments Tested in This Trial?

Interventions

• Epidural Electrical Stimulation

Trial Overview The study tests if epidural electrical stimulation (EES) at the cervical spine can counteract opioid-induced breathing problems during surgery. It will record how EES affects motor activity and respiratory function in human patients.

How Is the Trial Designed?

Group I: Electrical Stimulation group Experimental Treatment 1 Intervention

Epidural Electrical Stimulation of the Cervical Spinal Cord

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

Approved in United States as Spinal Cord Stimulation for:

• Chronic pain management
• Failed back syndrome
• Complex regional pain syndrome

Approved in European Union as Epidural Electrical Stimulation for:

• Chronic pain management
• Neuropathic pain
• Ischemic pain

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]

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]

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]

Spinal cord stimulation (SCS) is generally a safe and effective treatment option, with complications being uncommon according to a comprehensive literature review.

The review emphasizes the importance of proper patient selection and adherence to evidence-based guidelines to minimize the risk of complications during SCS implantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anticipating and preventing complications in spinal cord stimulator implantation. Falowski, SM., Tan, H., Parks, J., et al.[2023]

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]

Epidural spinal cord stimulation (ESES) was tested in 10 patients with advanced vascular occlusive disease, showing significant improvements in peripheral circulation as measured by transcutaneous oxygen levels, thermography, and laser-speckle measurements.

The most notable improvements in circulation occurred within the first 2-3 weeks of treatment, highlighting the potential efficacy of ESES for enhancing blood flow in patients with severe vascular issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epidural spinal electrical stimulation in the treatment of severe arterial occlusive disease. Steude, U., Abendroth, D., Sunder-Plassmann, L.[2019]

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 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]

In a study of 15 patients with cerebral palsy, Cervical Epidural Spinal cord Electrical Stimulation (E.S.E.S.) did not lead to significant improvements in spasticity, dyskinesia, or daily functioning, with most patients discontinuing treatment due to lack of benefits and complications.

Only three patients continued with E.S.E.S., but none showed clear improvements in their activities of daily living (ADL) or disability scores, leading to the conclusion that E.S.E.S. is not a recommended treatment for cerebral palsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cervical epidural spinal cord stimulation in infantile encephalopathy]. Speelman, JD.[2007]

Citations

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

Epidural Electrical Stimulation for Functional Recovery in ... Therefore, EES combined with PT significantly outperformed PT alone in restoring sensory function, muscle strength, spasticity, and urinary ...

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. 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.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07207798

Epidural Electrical Stimulation in Spinal Cord Injury (T11-L3) The primary objective of this clinical trial is to investigate the efficacy of Epidural Electrical Stimulation (EES) in restoring motor and sensory function ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11274919/

Selective Activation of the Spinal Cord with Epidural ... Spinal cord epidural electrical stimulation (EES) has been successfully employed to treat chronic pain and to restore lost functions after spinal cord injury.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07037628

Investigating the Impact of Spinal Cord Electrical ... This study aims to understand the differences in the effects of two rehabilitation approaches on lower limb function recovery in patients ...