Epidural Spinal Stimulation for Spinal Cord Injury

Overseen By Rachel Markley

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Methodist Hospital Research Institute

Must be taking: Anti-spasticity drugs

Must not be taking: Intrathecal baclofen, Botox

Disqualifiers: Neuromuscular conditions, Cardiopulmonary disease, Pregnancy, others

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

Compensation: Varies

Number of Visits: 16

12 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this study is to investigate the effects of cervical epidural spinal stimulation with upper extremity training. This is an investigational study. The device used for epidural spinal stimulation (ESS) to deliver spinal stimulation is called the CoverEdgeX 32 Surgical Lead system. This device is approved by the Food and Drug Administration (FDA) for the treatment of severe pain and to manage chronic pain when other treatments have not been effective. In this study, the device is considered an investigational device because it is not approved for use in the treatment of spinal cord injury

Will I have to stop taking my current medications?

The trial requires that you maintain your current oral anti-spasticity medication regimen and dosage as approved by the study physician, with no changes that might affect the study outcomes.

What data supports the effectiveness of the treatment Epidural Spinal Stimulation for Spinal Cord Injury?

Research shows that Epidural Spinal Stimulation can help improve movement and control in people with spinal cord injuries. It has been found to restore voluntary movement and improve functions like walking and muscle control, even in severe cases. ^{1 2 3 4 5}

Is epidural spinal stimulation generally safe for humans?

Epidural spinal stimulation has been studied for safety, and while rare complications like spinal cord injury have been reported, they are uncommon. Most issues are related to equipment failure rather than direct harm to the spinal cord. ^{3 6 7 8 9}

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

Epidural Spinal Stimulation is unique because it uses electrical impulses to activate dormant spinal circuits, potentially improving voluntary movements and functions like posture and bladder control after spinal cord injury. Unlike other treatments, it involves precise timing and frequency of stimulation to optimize locomotion, offering a novel approach to rehabilitation. ^{1 5 10 11 12}

Research Team

Dimitry Sayenko, MD, PhD

Principal Investigator

The Methodist Hospital Research Institute

Eligibility Criteria

This trial is for individuals aged 22-70 with a spinal cord injury that occurred between 6 months and 20 years ago. They must have stable medical conditions, maintain their anti-spasticity medication as approved by the study physician, and have certain levels of shoulder, elbow, wrist, and finger movement. Participants need to consent to all procedures and be available for the entire study.

Inclusion Criteria

Stated willingness to comply with all study procedures and availability for the duration of the study.

Eligible for fMRI per safety questionnaire.

All participants must provide a signed and dated informed consent form.

Exclusion Criteria

Clinically significant depression, psychiatric disorders, or ongoing drug abuse.

Any reason the PI or treating physician may deem as harmful to the participant or inappropriate for the participant to enroll or continue in the study.

Body Mass Index (BMI) over 30.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Implantation and Recovery

ESS electrodes are implanted and participants undergo a recovery phase

2 weeks

2 visits (in-person)

Initial Assessment and Treatment

Characterization of sensorimotor network responses, brain activation, and upper limb function with ESS

4 weeks

4 visits (in-person)

Responder Stratification and IPG Implantation

Participants are stratified into responders and non-responders; responders receive permanent IPG implantation

1 week

1 visit (in-person)

Rest and Clinical Examination

Participants rest and undergo repeated clinical examinations

2 weeks

2 visits (in-person)

Sham Stimulation and Assessment

Assessments occur with ESS active for only 30 seconds (Sham stimulation)

3 weeks

3 visits (in-person)

Parameter Refinement

Refinement of ESS parameters for functional movements

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

1 visit (in-person)

Treatment Details

Interventions

• Epidural Spinal Stimulation

Trial Overview The trial investigates cervical epidural spinal stimulation (ESS) using the CoverEdgeX 32 Surgical Lead system in combination with upper extremity training. Although FDA-approved for severe pain management, it's considered investigational here because it's not yet approved for treating spinal cord injuries.

Participant Groups

Group I: Epidural Spinal Stimulation (ESS) Experimental Treatment 1 Intervention

ESS will be delivered using The CoverEdgeX 32 Surgical Lead at frequencies of 0.2 to 60 Hz with intensity up to 10 mA, adjusted to induce motor threshold responses in the target muscle for the above motor task (e.g., biceps brachii for elbow flexion) \[31-33\]. The ESS controller will only be operated by trained study team members. Therefore, stimulation will only be delivered during study visits. Stimulation will be administered for a maximum duration of 1 hour total per visit, varying according to the individual's tolerance and fatigue levels, with 5 - 10 minutes breaks interspersed between intervals of stimulation.

Who Is Running the Clinical Trial?

The Methodist Hospital Research Institute

Lead Sponsor

Trials

299

Recruited

82,500+

Findings from Research

Spinal cord epidural stimulation (SCES) not only aids in facilitating walking but also improves cardiovascular autonomic regulation and reduces spasticity in a 27-year-old male with a complete spinal cord injury, as shown in assessments conducted 15 weeks apart.

The study demonstrated that SCES can stabilize blood pressure during postural changes and significantly reduce muscle spasticity, suggesting that a single SCES configuration can provide multiple functional benefits, which may enhance its clinical application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of percutaneously-implanted epidural stimulation on cardiovascular autonomic function and spasticity after complete spinal cord injury: A case report. Gorgey, AS., Goldsmith, J., Alazzam, A., et al.[2023]

A 25-year-old male with penetrating spinal cord injury from a gunshot wound regained partial voluntary movement and improved bowel function after receiving epidural spinal cord stimulation (eSCS).

This case suggests that eSCS may be a promising intervention for enhancing recovery in patients with penetrating spinal cord injuries, which has been less studied compared to nonpenetrating injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recovery of volitional movement with epidural stimulation after "complete" spinal cord injury due to gunshot: A case report and literature review. Gupta, R., Johnson, R., Samadani, U.[2023]

Epidural spinal cord stimulation (SCS) has shown promising results in improving motor function in 83 out of 88 individuals with spinal cord injury (SCI), indicating its potential effectiveness for enhancing mobility.

The treatment also significantly reduced spasticity in participants and improved control over urination, suggesting that SCS can positively affect both motor and voiding functions even in patients with complete SCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Scoping Review of Epidural Spinal Cord Stimulation for Improving Motor and Voiding Function Following Spinal Cord Injury. D'hondt, N., Marcial, KM., Mittal, N., et al.[2023]

Spinal cord epidural stimulation (SCES) combined with exoskeletal-assisted walking (EAW) showed promising results in enhancing motor control for a person with complete C7 spinal cord injury, reducing the need for swing assistance from 100% to 35% over 12 weeks.

The approach led to 573 unassisted steps, indicating improved muscle activation and potential for greater independence in movement, suggesting that SCES with EAW could be a practical rehabilitation method for individuals with spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The feasibility of using exoskeletal-assisted walking with epidural stimulation: a case report study. Gorgey, AS., Gill, S., Holman, ME., et al.[2021]

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]

In a study of 25 patients with chronic motor complete spinal cord injury, spinal cord epidural stimulation (scES) was found to be safe, with only 8% experiencing infections and 12% requiring additional procedures, while all participants achieved voluntary movement after the intervention.

The majority of patients (85%) reported that scES met or exceeded their expectations, and 100% expressed willingness to undergo the procedure again, indicating significant improvements in motor function and quality of life after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord epidural stimulation for motor and autonomic function recovery after chronic spinal cord injury: A case series and technical note. Boakye, M., Ball, T., Dietz, N., et al.[2023]

Spinal cord stimulation (SCS) is generally considered a safe procedure, but this report highlights four cases of neurological complications, including paraparesis, following SCS implantation, indicating that while rare, such injuries can occur.

Among the four patients, one experienced complete paraplegia, two had incomplete paraparesis, and one fully recovered, suggesting that outcomes can vary significantly and further research is needed to understand the true incidence of neurological injuries related to SCS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A report of paraparesis following spinal cord stimulator trial, implantation and revision. Smith, CC., Lin, JL., Shokat, M., et al.[2011]

This study will evaluate the effectiveness of EMG-induced rehabilitation treatment in enhancing muscle recovery in 20 patients with spinal cord injury (SCI) who are receiving epidural electrical stimulation, comparing it to conventional rehabilitation methods.

The trial will monitor various outcomes, including muscle strength, quality of life, and safety over a 6-month period, aiming to improve rehabilitation strategies for SCI patients post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and effectiveness of electromyography-induced rehabilitation treatment after epidural electrical stimulation for spinal cord injury: study protocol for a prospective, randomized, controlled trial. Sun, XP., Shi, JJ., Bao, Y., et al.[2022]

In a study of 69 patients with implanted spinal cord stimulators (SCSs) who underwent 78 MRI scans, the overall adverse event rate for off-label MRI use was low at 9.72%, with no serious adverse events reported.

All reported clinical adverse events were minor and resolved, suggesting that the benefits of MRI for pain management in patients with older SCS models may outweigh the associated risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Off-Label Magnetic Resonance Imaging (MRI) in Patients with Persistent Pain with Spinal Cord Stimulators: A Case Series. Ragukonis, T.[2022]

Epidural spinal cord stimulation can effectively elicit spinal motor evoked potentials (sMEPs) in forelimb muscles of rats after spinal cord injury, with the strength of these responses varying based on electrode placement and stimulation intensity.

sMEPs can serve as reliable biomarkers to optimize stimulation parameters for improving forelimb motor function, suggesting a more efficient method for determining effective treatment configurations compared to traditional empirical testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of optimal electrode configurations for epidural spinal cord stimulation in cervical spinal cord injured rats. Alam, M., Garcia-Alias, G., Shah, PK., et al.[2018]

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 spinal cord stimulation can effectively initiate voluntary leg movements and improve various functions in spinal rats, with significant results observed after just six training sessions and as early as three weeks post-injury.

The study identified that the timing and frequency of stimulation pulses between lumbar and sacral spinal cord segments are crucial for optimizing stepping performance, suggesting a new approach for enhancing locomotion recovery in individuals with paralysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unique Spatiotemporal Neuromodulation of the Lumbosacral Circuitry Shapes Locomotor Success after Spinal Cord Injury. Shah, PK., Sureddi, S., Alam, M., et al.[2018]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of percutaneously-implanted epidural stimulation on cardiovascular autonomic function and spasticity after complete spinal cord injury: A case report. [2023]

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

Recovery of volitional movement with epidural stimulation after "complete" spinal cord injury due to gunshot: A case report and literature review. [2023]

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

A Scoping Review of Epidural Spinal Cord Stimulation for Improving Motor and Voiding Function Following Spinal Cord Injury. [2023]

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

The feasibility of using exoskeletal-assisted walking with epidural stimulation: a case report study. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

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

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

Spinal cord epidural stimulation for motor and autonomic function recovery after chronic spinal cord injury: A case series and technical note. [2023]

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

A report of paraparesis following spinal cord stimulator trial, implantation and revision. [2011]

8. India pubmed.ncbi.nlm.nih.gov

Safety and effectiveness of electromyography-induced rehabilitation treatment after epidural electrical stimulation for spinal cord injury: study protocol for a prospective, randomized, controlled trial. [2022]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Off-Label Magnetic Resonance Imaging (MRI) in Patients with Persistent Pain with Spinal Cord Stimulators: A Case Series. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Evaluation of optimal electrode configurations for epidural spinal cord stimulation in cervical spinal cord injured rats. [2018]

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

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

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

Unique Spatiotemporal Neuromodulation of the Lumbosacral Circuitry Shapes Locomotor Success after Spinal Cord Injury. [2018]