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

Trial Summary

What is the purpose of this trial?

Opioid overdose suppresses brainstem respiratory circuits, causes apnea, and may result in death. Epidural electrical stimulation (EES) at the cervical spinal cord facilitated motor activity in rodents and humans, and we hypothesized that EES of the cervical spinal cord could antagonize opioid-induced respiratory depression in humans. In this study, we will stimulate the spinal cord during surgery and assess its effects on respiratory function in human patients.

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

Research shows that Epidural Electrical Stimulation (EES) can improve mobility and reduce spasticity (muscle stiffness) in patients with conditions like multiple sclerosis and myelopathy. It has also been effective in managing chronic pain in patients with spinal cord injuries and other conditions, providing significant pain relief for many individuals. ^{1 2 3 4 5}

Is epidural electrical stimulation generally safe for humans?

Epidural electrical stimulation has been used for decades and is considered a minor procedure, but it can have complications like broken or moved electrodes, spinal cord compression, infection, and other issues. These risks are known and efforts are made to minimize them. ^{1 2 6 7 8}

How is Epidural Electrical Stimulation different from other treatments for spinal cord disorders?

Epidural Electrical Stimulation (EES) is unique because it involves implanting electrodes to stimulate the spinal cord, which can help improve mobility and reduce pain in conditions like chronic pain and spasticity when other treatments fail. Unlike some treatments that may involve medication or surgery, EES is a reversible and minimally invasive procedure that directly targets the spinal cord to modulate nerve activity. ^{1 4 5 6 9}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 (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]

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 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]

References

1. Austria pubmed.ncbi.nlm.nih.gov

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

2. Netherlands pubmed.ncbi.nlm.nih.gov

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

3. Austria pubmed.ncbi.nlm.nih.gov

Epidural spinal electrical stimulation in the treatment of severe arterial occlusive disease. [2019]

4. 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]

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

Treatment of chronic pain by epidural spinal cord stimulation: a 10-year experience. [2011]

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

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

7. England pubmed.ncbi.nlm.nih.gov

Anticipating and preventing complications in spinal cord stimulator implantation. [2023]

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

Postsurgical pathologies associated with intradural electrical stimulation in the central nervous system: design implications for a new clinical device. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

[Epidural spinal cord stimulation for therapy of chronic pain. Summary of the S3 guidelines]. [2021]