Neural Signals for Spinal Cord Injury

Recruiting at 1 trial location

Overseen By Jonathan R Jagid, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Pregnancy, Under 18, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 8 weeks

3 Participants Needed

Trial Summary

What is the purpose of this trial?

The study will investigate the use of motor intention-based cortical signals to trigger epidural spinal cord stimulation (ESCS) with individuals with SCI. Motor intention of UL tasks will be decoded using brain-computer interface (BCI) system based on cortical signals recorded using an Electroencephalographic (EEG) system or using their intracranially implanted devices Electrocorticographic (ECoG).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Epidural Spinal Cord Stimulation for spinal cord injury?

Research shows that Epidural Spinal Cord Stimulation can help restore movement and improve functions in people with severe spinal cord injuries. It works by activating the spinal networks that control movement, allowing some individuals to stand, step, and regain voluntary control over their muscles. ^{1 2 3 4 5}

Is spinal cord stimulation generally safe for humans?

Spinal cord stimulation (SCS) is generally considered safe, but some complications like new pain or issues with the equipment can occur. Studies have shown it is a safe procedure for managing chronic pain, though there are rare cases of new pain after the device is implanted. ^{6 7 8 9 10}

How is epidural spinal cord stimulation different from other treatments for spinal cord injury?

Epidural spinal cord stimulation is unique because it uses electrical pulses to directly stimulate the spinal cord, which can help improve voluntary movement and other functions like posture and bladder control. Unlike other treatments, it focuses on optimizing the timing and frequency of these pulses to enhance the body's natural ability to recover movement after a spinal cord injury. ^{11 12 13 14 15}

Research Team

Jonathan Jagid, MD

Principal Investigator

University of Miami

Eligibility Criteria

This trial is for individuals with spinal cord injuries who are interested in testing new ways to control assistive devices using their brain signals. Participants should be willing to have their brain activity monitored and decoded, either through non-invasive EEG or implanted ECoG devices.

Inclusion Criteria

I have had a spinal cord injury for over 6 months with some remaining function.

Able to sign informed consent

Not participating in other studies that limit participation

Exclusion Criteria

I am unable to understand or sign the consent form.

Patients that are pregnant

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo a one-time surgery to have leads implanted temporarily for ESCS

1 week

1 visit (in-person)

Treatment

Participants receive Upper limb (UL) therapist-guided training with BCI-ESCS system

8 weeks

Multiple visits (in-person)

Follow-up

Participants are monitored for changes in movement kinematics, independence, hand motor function, muscle coordination, and quality of life

8 weeks

Treatment Details

Interventions

• Epidural Spinal Cord Stimulation

Trial Overview The study tests if motor intentions detected by a brain-computer interface (BCI) can effectively trigger epidural spinal cord stimulation (ESCS) to help control assistive devices. It uses EEG systems or intracranial ECoG implants to record and decode these signals.

Participant Groups

Group I: Brain Computer Interface-Epidural Spinal Cord Stimulation (BCI-ESCS) Experimental Treatment 3 Interventions

Participants in this group will receive a onetime surgery to have the leads implanted temporarily for ESCS which will be triggered through the BCI system. The BCI-ESCS arms will include Upper limb (UL) therapist-guided training, with triggered through a BCI system during task practice. The BCI system will decode motor intention of Upper limb (UL) tasks from cortical signals recorded using EEG system or using their intracranially implanted devices (e.g., ECoG). Participants will perform UL daily activities (e.g., grasping, reaching) tailored to participants deficits. The therapist will facilitate task practice and progress therapy within and between session. Subjects will be involved in the intervention for up to 2 months.

Epidural Spinal Cord Stimulation is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Spinal Cord Stimulation for:

• Failed back surgery syndrome
• Complex regional pain syndrome
• Chronic neuropathic pain
• Ischemic pain

Approved in United States as Spinal Cord Stimulation for:

• Failed back surgery syndrome
• Complex regional pain syndrome
• Chronic neuropathic pain
• Ischemic pain
• Diabetic neuropathy

Approved in Canada as Spinal Cord Stimulation for:

• Failed back surgery syndrome
• Complex regional pain syndrome
• Chronic neuropathic pain
• Ischemic pain

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Findings from Research

Epidural spinal cord stimulation has shown promise in restoring lower extremity and neurological functions in individuals with complete spinal cord injuries, suggesting it could be a beneficial adjunct to traditional rehabilitation methods.

The mechanism of action involves stimulating large diameter dorsal root proprioceptive afferents, which can activate spinal and supraspinal networks, potentially facilitating movements like standing and stepping, and improving other sensorimotor and autonomic functions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epidural spinal cord stimulation as an intervention for motor recovery after motor complete spinal cord injury. Hachmann, JT., Yousak, A., Wallner, JJ., et al.[2023]

Neuromodulation of the spinal cord can lead to recovery of motor, cardiovascular, and bladder functions in individuals with spinal cord injuries, even years post-injury, highlighting its therapeutic potential.

The integration of sensory feedback, task-specific training, and the activation of previously undetectable pathways allows for voluntary control of movements, suggesting that neuromodulation can significantly enhance recovery and improve quality of life for those affected.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Historical development and contemporary use of neuromodulation in human spinal cord injury. Harkema, S., Angeli, C., Gerasimenko, Y.[2023]

Epidural spinal cord stimulation can activate spared neural circuitry below severe spinal cord injuries, enabling paralyzed individuals to achieve motor outputs like standing and stepping during assisted treadmill exercises.

This stimulation not only generates immediate motor responses but also supports rehabilitation by promoting long-term neural plasticity, potentially leading to lasting improvements in motor function for patients with spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal Cord Stimulation and Augmentative Control Strategies for Leg Movement after Spinal Paralysis in Humans. Minassian, K., Hofstoetter, US.[2020]

Epidural stimulation has evolved from primarily suppressing pain in spinal cord injury patients to facilitating posture and locomotion, showing promise in helping individuals with severe spinal cord injuries regain movement.

Research indicates that the lumbosacral region of the spinal cord contains the necessary circuitry for normal locomotion, and combining epidural stimulation with pharmacological treatments and step training enhances locomotor patterns, suggesting a potential pathway for rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epidural stimulation: comparison of the spinal circuits that generate and control locomotion in rats, cats and humans. Gerasimenko, Y., Roy, RR., Edgerton, VR.[2022]

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]

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]

In a study of 402 patients with chronic pain who received spinal cord stimulation (SCS) devices, 55% of those with lower limb pain and 67% with upper limb pain reported a significant reduction in pain (≥50% reduction) after 2 years, indicating the long-term effectiveness of SCS.

The majority of patients (91%) were satisfied with their treatment, and 93% would choose to undergo the procedure again, while also showing a significant decrease in the need for pain medications, highlighting both the efficacy and safety of SCS therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation for chronic refractory pain: Long-term effectiveness and safety data from a multicentre registry. Brinzeu, A., Cuny, E., Fontaine, D., et al.[2019]

In a clinical trial involving 83 patients with chronic back pain, 88% reported significant pain relief after using a high-frequency spinal cord stimulation (SCS) system, with back pain scores dropping from an average of 8.4 to 2.7 after six months.

The high-frequency SCS system not only provided substantial pain relief without causing the tingling sensation (paresthesia) typical of traditional SCS but also improved patients' disability and sleep quality, confirming its safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-frequency spinal cord stimulation for the treatment of chronic back pain patients: results of a prospective multicenter European clinical study. Van Buyten, JP., Al-Kaisy, A., Smet, I., et al.[2022]

A new closed-loop spinal cord stimulation (SCS) system showed high efficacy in chronic pain management, with 92.6% of subjects reporting at least 50% pain relief for back pain and 91.3% for leg pain at three months post-implantation.

Significant improvements in quality of life and function were observed, with the mechanism of action likely involving feedback control that minimizes the recruitment of pain-related nerve fibers during stimulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effective Relief of Pain and Associated Symptoms With Closed-Loop Spinal Cord Stimulation System: Preliminary Results of the Avalon Study. Russo, M., Cousins, MJ., Brooker, C., et al.[2022]

In a retrospective case series of three patients, new-onset radicular pain in the L5/S1 dermatome was observed following spinal cord stimulation (SCS) insertion, suggesting potential complications despite the procedure's overall safety.

The cases highlighted the need for careful pre-procedure MRI analysis to avoid complications related to electrode placement, as well as the importance of discussing potential neurological risks with patients during the consent process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A case series of new radicular pain following the insertion of spinal cord stimulator. Baranidharan, G., Bretherton, B., Black, S.[2023]

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]

Spinal cord stimulation (SCS) not only produces fast epidural evoked compound action potentials (ECAPs) but also generates a delayed wave called the S1-wave, which reflects synaptic activity within the spinal cord, indicating a more complex response than previously understood.

The S1-wave, identified as evoked synaptic activity potentials (ESAPs), is sensitive to AMPA receptor antagonism and can be modulated by stimulation frequency, suggesting that it plays a significant role in the mechanisms of SCS and may contribute to its therapeutic effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel Evoked Synaptic Activity Potentials (ESAPs) Elicited by Spinal Cord Stimulation. Sharma, M., Bhaskar, V., Yang, L., et al.[2023]

Epidural electrical stimulation (EES) has shown promise in improving voluntary mobility in spinal cord injury (SCI) patients, indicating its potential as a therapeutic intervention for enhancing motor function.

The exact mechanisms by which EES promotes recovery are still unclear, but the review suggests that it may involve changes in local spinal circuitry and the activation of propriospinal interneurons, highlighting the need for further research using genetic tools to explore these mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epidural Electrical Stimulation: A Review of Plasticity Mechanisms That Are Hypothesized to Underlie Enhanced Recovery From Spinal Cord Injury With Stimulation. Eisdorfer, JT., Smit, RD., Keefe, KM., et al.[2022]

A study involving 106 patients with chronic pain showed that electrical stimulation of the dorsal neural structures in the spine can effectively generate sensory responses in areas of pain, indicating its potential for pain management.

The research identified specific body areas where stimulation is more effective, such as the hand and thigh, while noting challenges in stimulating areas like the neck and low back, highlighting the variability in response based on spinal levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mapping of sensory responses to epidural stimulation of the intraspinal neural structures in man. Barolat, G., Massaro, F., He, J., et al.[2011]

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]

References

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

Epidural spinal cord stimulation as an intervention for motor recovery after motor complete spinal cord injury. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Historical development and contemporary use of neuromodulation in human spinal cord injury. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Spinal Cord Stimulation and Augmentative Control Strategies for Leg Movement after Spinal Paralysis in Humans. [2020]

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

Epidural stimulation: comparison of the spinal circuits that generate and control locomotion in rats, cats and humans. [2022]

5. 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]

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

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

7. England pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation for chronic refractory pain: Long-term effectiveness and safety data from a multicentre registry. [2019]

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

High-frequency spinal cord stimulation for the treatment of chronic back pain patients: results of a prospective multicenter European clinical study. [2022]

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

Effective Relief of Pain and Associated Symptoms With Closed-Loop Spinal Cord Stimulation System: Preliminary Results of the Avalon Study. [2022]

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

A case series of new radicular pain following the insertion of spinal cord stimulator. [2023]

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

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

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

Novel Evoked Synaptic Activity Potentials (ESAPs) Elicited by Spinal Cord Stimulation. [2023]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Epidural Electrical Stimulation: A Review of Plasticity Mechanisms That Are Hypothesized to Underlie Enhanced Recovery From Spinal Cord Injury With Stimulation. [2022]

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

Mapping of sensory responses to epidural stimulation of the intraspinal neural structures in man. [2011]

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

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