Spinal Cord Stimulation for Spinal Cord Injury

Recruiting at 1 trial location

Overseen By James R McIntosh, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Stimulation devices, others

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

Compensation: Varies

Number of Visits: 1

36 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have stimulation devices in the neck or chest, you may not be eligible to participate.

What data supports the effectiveness of the treatment Intraoperative stimulation of the cervical spinal cord for spinal cord injury?

Spinal cord stimulation (SCS) has shown promise in restoring function after spinal cord injuries, as it is driven by advances in understanding spinal cord lesions and compensatory mechanisms. Although primarily used for pain management, new strategies like spatiotemporal neuromodulation, combined with intensive rehabilitation, are being explored for their potential to improve outcomes in spinal cord injury patients. ^{1 2 3 4 5}

Is spinal cord stimulation generally safe for humans?

Spinal cord stimulation, including cervical spinal cord stimulation, is generally considered safe with a low risk of complications. In a large study, the rate of spinal cord injury was 0.5%, and other complications were also relatively low, with no deaths reported. ^{2 6 7 8 9}

How is intraoperative stimulation of the cervical spinal cord different from other treatments for spinal cord injury?

Intraoperative stimulation of the cervical spinal cord is unique because it involves direct electrical stimulation during surgery, which may allow for precise targeting and immediate feedback on its effects, unlike other treatments that are typically administered post-surgery or through less direct methods. ^{4 5 10 11 12}

What is the purpose of this trial?

The proposed study seeks to understand how the cervical spinal cord should be stimulated after injury through short-term physiology experiments that will inform a preclinical efficacy trial. The purpose of this study is to determine which cervical levels epidural electrical stimulation (EES) should target to recruit arm and hand muscles effectively and selectively in spinal cord injury (SCI).

Eligibility Criteria

This trial is for individuals who need cervical spine surgery due to conditions like a broken neck, spinal cord injury, or quadriplegia. It's not open to those with stimulation devices in the neck or chest, such as vagal nerve stimulators or pacemakers.

Inclusion Criteria

I need surgery for my neck spine.

Exclusion Criteria

Stimulation devices in the neck or chest (e.g., vagal nerve stimulation, cardiac patients with pacemakers)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intraoperative Testing

Motor evoked responses to epidural electrical stimulation (EES) will be tested at cervical segments with and without myelopathy

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after intraoperative testing

4 weeks

Treatment Details

Interventions

• Intraoperative stimulation of the cervical spinal cord

Trial Overview The study is testing how stimulating the cervical spinal cord during surgery can help arm and hand muscle function after a spinal injury. Researchers want to find out which parts of the cervical spine should be targeted for optimal recovery.

Participant Groups

Group I: Arm 1 - Intraoperative Participants Experimental Treatment 1 Intervention

Motor evoked responses responses (MEPs) to epidural electrical stimulation (EES) will be tested at cervical segments with and without myelopathy in participants with cervical myelopathy.

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Findings from Research

The median time to explantation of high frequency 10 kHz spinal cord stimulators was found to be 3.5 years, with significant explantation rates of 11.1% at 1 year, 22.2% at 2 years, and 32.5% at 3 years among 126 patients studied.

Despite previous studies showing high efficacy of high frequency SCS for lower and leg pain, this study revealed a higher than expected explantation rate, highlighting the need for more longitudinal data to assess the long-term effectiveness and safety of this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Explantation Rates of High Frequency Spinal Cord Stimulation in Two Outpatient Clinics. Wang, VC., Bounkousohn, V., Fields, K., et al.[2022]

In a study analyzing 2053 cases of cervical spinal cord stimulation (cSCS) from 2002 to 2011, the rate of spinal cord injury was found to be 0.5%, which is higher than previously reported, indicating a need for careful patient selection and counseling.

Despite the spinal cord injury rate, cSCS remains a relatively safe procedure with low rates of other complications (1.1% neurological, 1.4% medical, and 11.7% general perioperative complications), making it a viable option for pain management in patients, especially in an aging population reliant on opioids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rate of perioperative neurological complications after surgery for cervical spinal cord stimulation. Chan, AK., Winkler, EA., Jacques, L.[2017]

Spinal cord stimulation (SCS) is evolving from a treatment for intractable pain to a potential method for restoring function after spinal cord injuries, driven by advances in understanding spinal cord lesions and compensatory mechanisms.

New SCS strategies, like spatiotemporal neuromodulation, show promise but require intensive rehabilitation techniques to be effective, highlighting the need for well-designed clinical trials to evaluate safety and efficacy in real-world applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in Spinal Cord Neuromodulation: The Integration of Neuroengineering, Computational Approaches, and Innovative Conceptual Frameworks. Pradat, PF., Hayon, D., Blancho, S., et al.[2023]

In a study of 19 patients undergoing spinal cord stimulation (SCS) lead placement under general anesthesia, 84.2% experienced adequate stimulation coverage and significant pain relief postoperatively, demonstrating the efficacy of this approach for patients unable to undergo awake procedures.

Using compound muscle action potentials (CMAPs) for lead placement guidance proved effective, as consistent results were achieved in 17 out of 19 procedures, indicating that this method can successfully compensate for the lack of patient feedback during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrophysiologic monitoring for placement of laminectomy leads for spinal cord stimulation under general anesthesia. Air, EL., Toczyl, GR., Mandybur, GT.[2022]

The study successfully demonstrated the feasibility of implanting surgical paddle electrodes in the cervical and thoracic spine using a minimally invasive endoscopic technique, with all procedures completed without complications in four cadavers.

No dura rupture occurred during the surgeries, and the implantation was efficient, with most operations taking less than one hour, indicating a promising alternative to traditional open surgery methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implantation of Surgical Paddle Electrodes Using Percutaneous Biportal-Endoscopic Technique for Spinal Cord Stimulation: An Anatomical Feasibility Study in Human Cadavers. Li, C., Jiang, Y., Liu, T., et al.[2023]

In a study involving 122 participants with chronic low back and/or leg pain, multiphase spinal cord stimulation (SCS) significantly reduced pain levels, with mean reductions of -4.3 and -4.7 on the numerical rating scale for two different multiphase therapies.

The multiphase SCS therapies were found to be safe, with only one non-serious device-related adverse event reported and no infections, suggesting a favorable safety profile for this new stimulation paradigm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiphase Spinal Cord Stimulation in Participants With Chronic Back or Leg Pain: Results of the BENEFIT-02 Randomized Clinical Trial. Kapural, L., Patterson, DG., Li, S., et al.[2023]

In a study of 68 patients who had spinal cord stimulation paddle electrodes removed, the most common reason for removal was loss of coverage or effect (75%), indicating that while SCS is effective, it may not always provide lasting relief.

Postoperative complications occurred in 11.75% of patients, with two major complications requiring reoperation, highlighting that while SCS removal is generally safe, it does carry some risks that patients should be aware of.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rate of Complications Following Spinal Cord Stimulation Paddle Electrode Removal. Maldonado-Naranjo, AL., Frizon, LA., Sabharwal, NC., et al.[2022]

Continuous electrical stimulation of the spinal cord at intensities greater than 10 mA for 30 minutes can cause permanent damage, including changes in spinal cord evoked potentials and tissue necrosis.

Intermittent stimulation at 10 mA with 1-minute resting intervals appears to be safe, as no spinal cord lesions were observed, suggesting a safer approach for spinal cord monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of epidural electrical stimulation modalities on spinal cord function and morphology in cats. Takakuwa, K., Tsuji, H., Takano, H., et al.[2013]

A new technique for placing a cervical spinal cord electrode under general anesthesia was successfully demonstrated in a 37-year-old man, allowing for intraoperative testing to ensure optimal lead positioning.

Post-surgery, the patient experienced excellent pain relief in the right shoulder and arm, indicating the effectiveness of the electrode placement without affecting the left side of the body.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cortical evoked potentials used for placement of a laminotomy lead array: a case report. Penar, PL., McSherry, J.[2022]

In a study of 119 patients with failed back surgery syndrome, spinal cord stimulation using laminectomy lead placement under epidural anaesthesia resulted in satisfactory pain relief, with 58% improvement in axial pain and 60% in radicular pain after an average follow-up of 4.7 years.

The technique was found to be safe, with no serious complications reported, and patients did not experience pain during the procedure, although 6 patients required explantation of the system due to ineffectiveness or intolerance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Spinal cord stimulation and failed back surgery syndrome. Clinical results with laminectomy electrodes]. García March, G., Bordes, V., Roldán, P., et al.[2015]

Spinal cord stimulation (SCS) shows potential effectiveness in treating chronic pain conditions like Complex Regional Pain Syndrome Type I and Failed Back Surgery Syndrome, based on two trials involving 81 patients, although the evidence is limited and more research is needed.

The studies reviewed had varying quality, with one high-quality trial and one low-quality trial, indicating a need for better-designed studies to accurately assess the efficacy and safety of SCS in chronic pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation for chronic pain. Mailis-Gagnon, A., Furlan, AD., Sandoval, JA., et al.[2018]

In a study of 24 patients with chronic lumbosacral pain, an insulated four-contact electrode implanted via laminectomy significantly outperformed a temporary percutaneous electrode in terms of pain coverage and required lower stimulation amplitudes, suggesting better efficacy.

The insulated array's improved performance could potentially double battery life compared to the percutaneous electrode, indicating a more efficient option for spinal cord stimulation, although further follow-up is needed to confirm long-term clinical benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation electrode design: prospective, randomized, controlled trial comparing percutaneous and laminectomy electrodes-part I: technical outcomes. North, RB., Kidd, DH., Olin, JC., et al.[2019]

References

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

Explantation Rates of High Frequency Spinal Cord Stimulation in Two Outpatient Clinics. [2022]

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

Rate of perioperative neurological complications after surgery for cervical spinal cord stimulation. [2017]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Advances in Spinal Cord Neuromodulation: The Integration of Neuroengineering, Computational Approaches, and Innovative Conceptual Frameworks. [2023]

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

Electrophysiologic monitoring for placement of laminectomy leads for spinal cord stimulation under general anesthesia. [2022]

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

Implantation of Surgical Paddle Electrodes Using Percutaneous Biportal-Endoscopic Technique for Spinal Cord Stimulation: An Anatomical Feasibility Study in Human Cadavers. [2023]

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

Multiphase Spinal Cord Stimulation in Participants With Chronic Back or Leg Pain: Results of the BENEFIT-02 Randomized Clinical Trial. [2023]

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

Rate of Complications Following Spinal Cord Stimulation Paddle Electrode Removal. [2022]

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

Effects of epidural electrical stimulation modalities on spinal cord function and morphology in cats. [2013]

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

Cortical evoked potentials used for placement of a laminotomy lead array: a case report. [2022]

10. Spain pubmed.ncbi.nlm.nih.gov

[Spinal cord stimulation and failed back surgery syndrome. Clinical results with laminectomy electrodes]. [2015]

11. England pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation for chronic pain. [2018]

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

Spinal cord stimulation electrode design: prospective, randomized, controlled trial comparing percutaneous and laminectomy electrodes-part I: technical outcomes. [2019]