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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the most effective use of electrical stimulation on the neck to help individuals with spinal cord injuries regain arm and hand function. Researchers seek to identify which areas of the neck's spinal cord should receive electrical pulses during surgery. The trial is intended for individuals requiring cervical spine surgery due to conditions such as cervical myelopathy, where the spinal cord in the neck is compressed. Participants should not have devices like pacemakers in their neck or chest. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance treatment options for spinal cord injuries.

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

Research shows that stimulating the spinal cord during surgery helps monitor its function and can make spinal operations safer. Although this procedure carries some risks, studies have found that the chance of causing a spinal cord injury is about 0.5% in a large group of patients. Despite this risk, the procedure is considered valuable in surgical settings. Overall, while complications are possible, this method effectively manages spinal surgeries. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about spinal cord stimulation for spinal cord injury because it offers a novel approach to potentially restore motor function. Unlike traditional treatments for spinal cord injuries, which often focus on physical therapy and medication to manage symptoms, this method directly stimulates the cervical spinal cord using epidural electrical stimulation (EES). This technique aims to activate motor pathways that might still be intact but dormant, potentially leading to improved motor function in areas affected by cervical myelopathy. By targeting the spinal cord directly, this method could offer new hope for recovery and functional improvement beyond what current therapies can achieve.

What evidence suggests that intraoperative stimulation of the cervical spinal cord is effective for spinal cord injury?

Research has shown that stimulating the spinal cord during surgery can improve arm and hand movement in people with spinal cord injuries. In this trial, participants will receive intraoperative stimulation of the cervical spinal cord. Studies have found that targeting the area where nerves enter the spine is more effective than other areas. By measuring muscle response, doctors can evaluate changes during surgery. This method aims to enhance understanding and treatment of muscle function after injury. Early results suggest it could improve arm and hand mobility in patients with neck-level spinal injuries. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Congressionally Directed Medical Research Programs

Collaborator

Trials

59

Recruited

10,600+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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 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]

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]

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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9799146/

Intraoperative electrical stimulation of the human dorsal spinal ... Consistent with this model, we have shown that stimulating near the dorsal root entry zone is more effective than stimulating at midline in the cervical spinal ...

2. bmcneurol.biomedcentral.com bmcneurol.biomedcentral.com/articles/10.1186/s12883-020-01799-w

The prediction of intraoperative cervical cord function changes ... Motor evoked potential (MEP) has proved to be helpful tool in evaluating intraoperative cervical spinal cord function change of those patients.

3. biorxiv.org biorxiv.org/content/10.1101/2022.01.29.478182v1.full-text

An actionable map of arm and hand muscle responses to ... The current study used electrical stimulation during clinically indicated cervical spine surgery to improve understanding of cervical spinal ...

4. thejns.org thejns.org/spine/view/journals/j-neurosurg-spine/19/4/article-p395.xml

Efficacy of intraoperative monitoring of transcranial electrical ... Patients were included in the study if they had preoperative deltoid strength of 4/5 or greater, as determined by manual muscle testing.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7819792/

Successful Motor Evoked Potential Monitoring in Cervical ... This study aimed to assess the success rate of IONM in patients with cervical myelopathy and to investigate the factors associated with successful baseline ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7261380/

The prediction of intraoperative cervical cord function ... Motor evoked potential (MEP) has proved to be helpful tool in evaluating intraoperative cervical spinal cord function change of those patients.

7. thejns.org thejns.org/spine/view/journals/j-neurosurg-spine/25/1/article-p31.xml

Rate of perioperative neurological complications after surgery ... In the largest series of cSCS, the risk of spinal cord injury was higher than previously reported (0.5%). Nonetheless, this procedure remains ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1529943025002517

Spinal cord status assessment and early interventional ... This study was a double-blind randomized controlled trial comparing two postoperative rehabilitation strategies for patients with CCM following endoscopic ...

9. journals.4science.ge journals.4science.ge/index.php/jr/article/view/4204

The Impact of Intraoperative Monitoring on Spinal Cord ... It has been shown that IONM is an important way of improving the safety of spinal surgery, especially in high-risk surgery like intramedullary ...

10. journals.lww.com journals.lww.com/isoj/fulltext/2025/01000/correlation_of_intraoperative_neuromonitoring.4.aspx

Correlation of Intraoperative Neuromonitoring (IONM) ... The findings suggest that patients with deterioration in the IONM signals during cervical cord decompression did not have a significant neurological recovery ...