Spinal Cord Stimulation for Spinal Cord Injury

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Susan Harkema PhD

Disqualifiers: Ventilator dependence, Untreated psychiatric disorder, Cardiovascular disease, others

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

Compensation: Varies

Number of Visits: 160

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for individuals with severe paralysis due to spinal cord injury. It seeks to determine if spinal cord stimulation (sending electrical signals to the spine) can restore movement, enabling participants to stand, step, and move voluntarily. Researchers will evaluate how well this stimulation enhances movement and its effects on heart, lung, bladder, bowel, and sexual functions. Ideal participants have a stable medical condition and a spinal cord injury for at least two years, without the ability to walk or move their leg joints voluntarily. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could significantly improve the quality of life for those with 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. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this spinal cord stimulation technique is safe for individuals with spinal cord injury?

Research has shown that spinal cord epidural stimulation (scES) is generally safe for people with spinal cord injuries. Studies have found its safety comparable to its use in treating long-term pain, typically resulting in few serious side effects.

Reports indicate significant improvements in movement for those with spinal cord injuries. About 44% of patients could stand or walk with assistance or independently, while approximately 87% showed some level of improvement.

Long-term studies continue to explore the effects of scES over time. However, scES appears well-tolerated and safe for individuals with severe spinal cord injuries. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about spinal cord epidural stimulation for spinal cord injury because it offers a new approach to restoring movement. Unlike traditional treatments, which mainly focus on physical therapy and medication to manage symptoms, this technique directly stimulates the spinal cord to enable standing, stepping, and voluntary movements. This innovative method could potentially improve mobility and independence for individuals with spinal cord injuries, marking a significant shift from current care options.

What evidence suggests that spinal cord epidural stimulation is effective for spinal cord injury?

Research has shown that spinal cord epidural stimulation (scES) can enhance movement in individuals with severe spinal cord injuries. Studies found that 89% of participants experienced improved movement with this treatment. In this trial, participants will undergo Stand, Step, and Voluntary Training using scES. Epidural electrical stimulation (EES) has also enabled individuals to regain control over paralyzed muscles through repeated practice. This technique has been linked to improved standing, walking, voluntary movements, and better bladder and bowel function. Overall, scES appears promising in aiding recovery of some physical abilities in those with spinal cord injuries. ^{2 4 6 7 8}

Who Is on the Research Team?

Susan Harkema, PhD

Principal Investigator

University of Louisville

Are You a Good Fit for This Trial?

This trial is for individuals with severe, non-progressive spinal cord injury (SCI) who are at least two years post-injury. Participants must be unable to walk independently or move all leg joints voluntarily and should have a stable medical condition. It's not suitable for those with untreated musculoskeletal issues, psychiatric disorders, ongoing drug abuse, unrelated cardiovascular diseases, or women who are or plan to become pregnant.

Inclusion Criteria

I cannot move all the joints in my legs on my own.

It has been over 2 years since my injury.

I cannot walk on my own without help.

Exclusion Criteria

I have untreated painful bone or muscle issues, fractures, or pressure sores.

I have heart, lung, bladder, or kidney conditions not caused by my spinal cord injury.

I rely on a machine to help me breathe.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training

Participants undergo task-specific epidural stimulation and training for recovery of stepping, standing, and voluntary movement

1 year

160 sessions

Follow-up

Participants are monitored for safety and effectiveness after training

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Standing, Stepping and Voluntary Movement with spinal cord Epidural Stimulation

Trial Overview The study tests if activating spinal circuits using Epidural Stimulation (scES) can help people with SCI regain the ability to stand, step and move voluntarily. There will be specific scES configurations used during training sessions aimed at improving movement control as well as cardiovascular and respiratory functions.

How Is the Trial Designed?

Group I: Stand, Step and Voluntary Training Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

Susan Harkema PhD

Lead Sponsor

Trials

2

Recruited

30+

Susan Harkema

Lead Sponsor

Trials

1

Recruited

20+

The Leona M. and Harry B. Helmsley Charitable Trust

Collaborator

Trials

69

Recruited

101,000+

Published Research Related to This Trial

In a study of 138 patients with chronic neuropathic pain, 74.7% experienced over 50% pain reduction after trialing spinal cord stimulation (SCS), leading to permanent implantation for most of them.

One year after implantation, 84.4% of patients maintained significant pain relief, and many reported improved daily functioning and reduced reliance on opiate analgesics, highlighting SCS as an effective treatment option in a multidisciplinary pain management setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation: a seven-year audit. Sundaraj, SR., Johnstone, C., Noore, F., et al.[2005]

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]

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 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 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]

Citations

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

Epidural Spinal Cord Stimulation for Spinal Cord Injury in ... The average success rate of eSCS across studies for GMA was 89% (CI: 0.924, 0.9331). All studies with BWS outcomes reported decreased BWS, and ...

2. 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 ...

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

Epidural Electrical Stimulation for Functional Recovery in ... Repeated training with EES can enhance motor control and enable individuals to regain voluntary control over paralyzed muscles [23–25]. Clinical ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0003999322002349

Spinal Cord Stimulation Research in the Restoration of ... Motor recovery was the most common primary outcome for epidural and transcutaneous SCS studies, whereas bowel and bladder outcomes were most common for magnetic ...

5. 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 ...

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

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

7. clinicaltrials.gov clinicaltrials.gov/study/NCT07042815

Long-term Follow-up for Epidural Stimulation in SCI The goal of this study is to understand long-term effects of spinal cord stimulation in individuals who have a spinal cord injury.

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 ...