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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach to help individuals with spinal cord injuries regain arm movement. It uses the CoverEdgeX 32 device, which sends electrical signals to the spine to stimulate muscles, a process known as Epidural Spinal Stimulation. The study aims to determine if this improves arm and hand movements when combined with physical training. Suitable candidates are those with a stable spinal cord injury for at least six months who can passively move their arms and fingers within normal limits. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could transform rehabilitation for spinal cord injuries.

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 prior data suggests that this device is safe for spinal cord injury treatment?

Research has shown that the safety of epidural spinal stimulation (ESS) for spinal cord injuries is similar to its use for chronic pain. ESS is generally well-tolerated, with few serious complications reported. Studies have found that patients usually respond well to the treatment, indicating it is relatively safe. The device used in this study already has FDA approval for severe and chronic pain, providing some confidence in its safety, even though it is still being tested for spinal cord injury. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Epidural Spinal Stimulation (ESS) for spinal cord injury because it offers a unique approach to restoring movement. Unlike traditional treatments, which often focus on rehabilitation exercises or medication to manage symptoms, ESS uses electrical stimulation to directly activate nerve pathways in the spinal cord. This method can potentially enhance motor function by targeting specific muscles, such as the biceps for elbow flexion, in a controlled manner. The precision and customization of ESS make it a promising option for improving quality of life for individuals with spinal cord injuries.

What evidence suggests that this device is effective for spinal cord injury?

Research has shown that epidural spinal stimulation (ESS), which participants in this trial will receive, may improve movement in people with spinal cord injuries. In one study, 44% of participants could walk or stand with assistance or independently after receiving ESS. Additionally, 87% experienced significant improvements in mobility. Another study found that ESS, especially when combined with physical therapy, supports recovery. Although the device is primarily approved for treating chronic pain, these findings suggest it could also benefit those with spinal cord injuries. ^{5 6 7 8 9}

Who Is on the Research Team?

Dimitry Sayenko, MD, PhD

Principal Investigator

The Methodist Hospital Research Institute

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9297213/

Effect of epidural spinal cord stimulation after chronic spinal ... The aim of this study is to assess the effects of tonic eSCS after chronic SCI on quantitative outcomes of volitional movement and cardiovascular function.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10889415/

Epidural Spinal Cord Stimulation for Spinal Cord Injury in ... Results indicated significant improvements in motor function: 44% of patients achieved assisted or independent stepping or standing; 87% showed ...

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

Epidural Electrical Stimulation for Functional Recovery in ... This study confirms the promising therapeutic effects of EES in SCI. EES combined with PT provides a potential approach for functional recovery in patients ...

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 ...

5. nature.com nature.com/articles/s41591-024-02940-9

Non-invasive spinal cord electrical stimulation for arm and ... ARCEX Therapy was found to be safe and effective in 72% of participants to mediate improvements of strength and function in the hands and arms ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35701485/

The safety of epidural spinal cord stimulation to restore ... eSCS to restore autonomic and volitional motor function following SCI has a similar safety profile as when used to treat chronic pain.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT07105878

Epidural Electrical Stimulation in Spinal Cord Injury The goal of this clinical trial is to evaluate the safety and effectiveness of Epidural Electrical Stimulation (EES) in motor and sensory function ...

8. nature.com nature.com/articles/s41467-023-37845-7

A case study of percutaneous epidural stimulation to ... The safety of epidural spinal cord stimulation to restore function after spinal cord injury: post-surgical complications and incidence of ...

9. e-neurospine.org e-neurospine.org/journal/view.php?doi=10.14245/ns.2244652.326

A Review of Functional Restoration From Spinal Cord ... In general, there was good tolerability of the intervention by patients with few significant complications. Table 4. Outcomes of selected ...