Spinal Cord Stimulation for Spinal Cord Injury

Overseen By Dimitry Sayenko, MD, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: The Methodist Hospital Research Institute

Must be taking: Anti-spasticity drugs

Must not be taking: Botox, Intrathecal baclofen

Disqualifiers: Cardiopulmonary disease, Depression, BMI over 30, others

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

Compensation: Varies

Number of Visits: 3

Duration: 5 weeks

60 Participants Needed

Trial Summary

What is the purpose of this trial?

It has been demonstrated that the human lumbosacral spinal cord can be neuromodulated with epidural (ESS) and transcutaneous (TSS) spinal cord stimulation to enable recovery of standing and volitional control of the lower limbs after complete motor paralysis due to spinal cord injury (SCI). The work proposed herein will examine and identify distinct electrophysiological mechanisms underlying transcutaneous spinal stimulation (TSS) and epidural spinal stimulation (ESS) to define how these approaches determine the ability to maintain self-assisted standing after SCI.

Will I have to stop taking my current medications?

The trial requires that you maintain your current oral anti-spasticity medication regimen without changes, as approved by the study physician.

What data supports the effectiveness of the treatment Epidural Spinal Stimulation (ESS) and Transcutaneous Spinal cord Stimulation (TSS) for spinal cord injury?

Research shows that Epidural Spinal Stimulation (ESS) can help restore voluntary movement and improve autonomic functions (like heart rate and blood pressure control) after spinal cord injuries. Transcutaneous Spinal cord Stimulation (TSS) has been found to enhance muscle activation and improve motor function in people with spinal cord injuries, suggesting it could be a promising treatment option. ^{1 2 3 4 5}

Is spinal cord stimulation generally safe for humans?

Spinal cord stimulation is generally considered safe, but there can be complications like surgical site infections, hardware issues, and less common neurological effects such as tinnitus (ringing in the ears) and vertigo (dizziness). These symptoms can resolve after deactivating the device, and further research is needed to fully understand these risks. ^{4 5 6 7 8}

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

Epidural Spinal Stimulation (ESS) is unique because it can partially restore motor function and improve autonomic functions like blood pressure regulation after spinal cord injury, which is not typically addressed by other treatments. It works by stimulating the spinal cord with electrical impulses, which can help improve movement and reduce symptoms like spasticity. ^{2 3 5 9 10}

Research Team

Dimitry Sayenko, MD, PhD

Principal Investigator

The Methodist Hospital Research Institute

Eligibility Criteria

This trial is for adults aged 22-60 with stable spinal cord injuries (1-6 years post-injury) below the neck and above the waist. They must be able to move their arms, sit upright for at least 15 minutes, and commit to the full study duration. Excluded are those with other ongoing conditions that limit physical activity, recent Botox injections in lower body muscles, or a BMI over 30.

Inclusion Criteria

Able to provide paperwork from personal primary treating physician that proves stable medical condition with ability to tolerate at least 15 minutes upright

Women of childbearing potential must agree to the use of an effective means of avoiding pregnancy for the duration of the study

Able to commit to the full study

Exclusion Criteria

I have active pressure sores, unhealed fractures, nerve pain, or muscle and joint pain.

I have or had a muscle or nerve condition.

I use a baclofen pump for muscle stiffness.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Initial assessments of neurological status, force generation, and independence

6 weeks

2 visits (in-person)

Treatment

Participants receive spinal neuromodulation therapy using TSS and ESS

5 weeks

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 weeks

1 visit (in-person)

Treatment Details

Interventions

• Epidural Spinal Stimulation (ESS)
• Transcutaneous Spinal cord Stimulation

Trial Overview The trial tests how non-invasive spinal stimulation techniques—Epidural Spinal Stimulation (ESS) and Transcutaneous Spinal cord Stimulation (TSS)—can help people regain standing ability after complete motor paralysis from spinal cord injury. It explores the electrical mechanisms of these treatments.

Participant Groups

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

Stimulation delivered internally using an implanted device operated by an external control (only used during research visits).

Group II: Transcutaneous Spinal Stimulation (TSS) Active Control 1 Intervention

Spinal Stimulation delivered over the skin using a research stimulator with conventional surface electrodes during research visits.

Group III: Sham Placebo Group 1 Intervention

Sham Stimulation delivered over the skin using a research stimulator with conventional surface electrodes during research visits. Sham stimulation will be delivered using the intensity of stimulation set as during active sessions of ESS, but then gradually decreased down to zero in approximately 30 s. There will be 5-10 minute breaks interspersed between intervals of stimulation, and will vary according to the individual's tolerance and fatigue levels

Epidural Spinal Stimulation (ESS) is already approved in European Union, United States for the following indications:

Approved in European Union as Epidural Spinal Stimulation (ESS) for:

• Chronic pain
• Failed back surgery syndrome
• Complex regional pain syndrome
• Intractable angina
• Visceral abdominal and perineal pain
• Pain in the extremities from nerve damage

Approved in United States as Epidural Spinal Stimulation (ESS) for:

• Chronic pain
• Failed back surgery syndrome
• Complex regional pain syndrome
• Intractable angina
• Visceral abdominal and perineal pain
• Pain in the extremities from nerve damage

Who Is Running the Clinical Trial?

The Methodist Hospital Research Institute

Lead Sponsor

Trials

299

Recruited

82,500+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Findings from Research

Noninvasive transcutaneous spinal cord stimulation (tSCS) has been shown to effectively induce muscle activation in individuals with spinal cord injury, based on a systematic review of 13 studies involving 55 participants.

While tSCS appears to enhance voluntary movement, muscle strength, and function, further research is needed to determine the optimal electrode placement and current intensity for maximum efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous Spinal Cord Stimulation and Motor Rehabilitation in Spinal Cord Injury: A Systematic Review. Megía García, A., Serrano-Muñoz, D., Taylor, J., et al.[2021]

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]

Cervical transcutaneous spinal cord stimulation (tSCS) can effectively activate sensory fibers at lower stimulation intensities when the cathode electrode is positioned at the C7 or T1 vertebra, compared to C6, which may enhance rehabilitation outcomes for upper-limb motor recovery after spinal cord injury.

Using smaller electrode sizes not only lowers the activation threshold for sensory fibers but also optimizes the recruitment of these fibers before α-motor fibers, suggesting a strategic approach to improve hand muscle activation during tSCS therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing sensory fiber activation during cervical transcutaneous spinal stimulation using different electrode configurations: A computational analysis. de Freitas, RM., Capogrosso, M., Nomura, T., et al.[2022]

Epidural spinal cord stimulation (ESCS) has shown potential for improving motor function in individuals with spinal cord injury, with 18 studies reviewed reporting some level of improvement in motor activity among 24 participants.

Despite the encouraging results, the overall therapeutic efficacy of ESCS remains inconclusive due to the poor quality of studies and the heterogeneity of outcome measures, which prevented a meta-analysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epidural spinal cord stimulation for motor recovery in spinal cord injury: A systematic review. McHugh, C., Taylor, C., Mockler, D., et al.[2021]

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]

A patient experienced neurological complications, including tinnitus, vertigo, and facial twitches, after receiving a high-frequency spinal cord stimulator, which resolved upon deactivation of the device.

This case highlights the need for further research into the less common neurological side effects of spinal cord stimulation therapy, as current knowledge primarily focuses on surgical site infections and hardware issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Onset Tinnitus after High-Frequency Spinal Cord Stimulator Implantation. Golovlev, AV., Hillegass, MG.[2020]

Transcutaneous spinal cord stimulation (tSCS) shows potential for generating motor activity in individuals with spinal cord injury, but the overall quality of the studies reviewed was poor-to-fair, indicating a need for more rigorous research.

The review identified significant variability in stimulation parameters and outcome measurements across the 25 studies analyzed, highlighting the necessity for standardized methods to improve the reliability and comparability of tSCS research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous spinal cord stimulation and motor responses in individuals with spinal cord injury: A methodological review. Taylor, C., McHugh, C., Mockler, D., et al.[2022]

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]

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]

Epidural electrical spinal cord stimulation (ESCS) has shown promise not only in managing chronic pain but also in partially restoring motor function and neurological recovery in patients with spinal cord injuries, particularly when combined with rehabilitative therapies.

ESCS is also being explored for treating autonomic dysfunctions, such as orthostatic hypotension, indicating its potential to become a routine therapy for various complications following spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beyond treatment of chronic pain: a scoping review about epidural electrical spinal cord stimulation to restore sensorimotor and autonomic function after spinal cord injury. Luz, A., Rupp, R., Ahmadi, R., et al.[2023]

References

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

Transcutaneous Spinal Cord Stimulation and Motor Rehabilitation in Spinal Cord Injury: A Systematic Review. [2021]

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

Optimizing sensory fiber activation during cervical transcutaneous spinal stimulation using different electrode configurations: A computational analysis. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Epidural spinal cord stimulation for motor recovery in spinal cord injury: A systematic review. [2021]

5. Austria pubmed.ncbi.nlm.nih.gov

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

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

New Onset Tinnitus after High-Frequency Spinal Cord Stimulator Implantation. [2020]

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

Transcutaneous spinal cord stimulation and motor responses in individuals with spinal cord injury: A methodological review. [2022]

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

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

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

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

10. England pubmed.ncbi.nlm.nih.gov

Beyond treatment of chronic pain: a scoping review about epidural electrical spinal cord stimulation to restore sensorimotor and autonomic function after spinal cord injury. [2023]