Spinal Cord Stimulation for Spinal Cord Injury

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Susan Harkema PhD

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

Compensation: Varies

Number of Visits: 160

16 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will determine the level of functional gain, below the injury for voluntary control of movements, and recovery standing and stepping function as a result of activation of spinal circuits with scES in humans with severe paralysis. Training will consist of practicing stepping, standing and voluntary movements in the presence of specific scES configurations designed specific for stepping (Step-scES), specific for standing (Stand-scES) and for the voluntary movements of the legs and trunk (Vol-scES). Ability to step, stand, move voluntarily, as well as cardiovascular, respiratory, bladder, bowel and sexual function will be assessed in these individuals with chronic severe spinal cord injury.

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 data supports the effectiveness of the treatment for spinal cord injury?

Research shows that spinal cord epidural stimulation can help people with severe spinal cord injuries regain some voluntary leg movements and improve functions like standing and stepping. This treatment works by activating the spinal cord's neural circuits, which can lead to better motor control and recovery. ^{1 2 3 4 5}

Is spinal cord stimulation generally safe for humans?

Spinal cord epidural stimulation has been used in humans for various conditions, including spinal cord injuries, and has shown improvements in movement and quality of life. While the research highlights benefits, it also notes surgical and training complications, indicating that while generally safe, there are risks involved. ^{5 6 7 8 9}

How does spinal cord epidural stimulation differ from other treatments for spinal cord injury?

Spinal cord epidural stimulation is unique because it uses electrical impulses to activate the spinal cord's own neural circuits, enabling movements like standing and stepping even in individuals with severe spinal cord injuries. Unlike other treatments, it directly targets the spinal cord to enhance its excitability and promote motor function recovery through task-specific training. ^{1 4 5 7 10}

Research Team

Susan Harkema, PhD

Principal Investigator

University of Louisville

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

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

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

Targeting Lumbar Spinal Neural Circuitry by Epidural Stimulation to Restore Motor Function After Spinal Cord Injury. [2018]

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

Predictors of volitional motor recovery with epidural stimulation in individuals with chronic spinal cord injury. [2021]

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

Spinal Cord Epidural Stimulation for Lower Limb Motor Function Recovery in Individuals with Motor Complete Spinal Cord Injury. [2019]

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

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

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. England pubmed.ncbi.nlm.nih.gov

Stepping-like movements in humans with complete spinal cord injury induced by epidural stimulation of the lumbar cord: electromyographic study of compound muscle action potentials. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

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

9. Scotland pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation: a seven-year audit. [2005]

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

Evidence for a spinal central pattern generator in humans. [2022]