Neuromodulation for Spinal Cord Injury

Overseen By Daniel Lu, MD PhD

Age: 18 - 65

Sex: Male

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Disqualifiers: Autonomic dysreflexia, Ventilator dependency, Depression, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

24 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial will investigate the safety and utility of spinal cord neuromodulation to improve urinary bladder function in the context of 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 Electromagnetic Neuromodulation for spinal cord injury?

Research shows that neuromodulation, including non-invasive methods, can improve motor function in people with spinal cord injuries. Studies have demonstrated increased hand grip strength and voluntary control in patients after neuromodulation sessions, suggesting potential benefits for spinal cord injury recovery. ^{1 2 3 4 5}

Is neuromodulation for spinal cord injury generally safe for humans?

Neuromodulation, including spinal cord stimulation, is generally considered safe for humans, with no long-term side effects reported. It is a reversible treatment option often used when other less invasive treatments have not worked. ^{1 3 6 7 8}

How is Electromagnetic Neuromodulation different from other treatments for spinal cord injury?

Electromagnetic Neuromodulation is unique because it uses electrical and magnetic stimulation to alter nerve activity, potentially restoring movement and function after spinal cord injury. Unlike traditional treatments, it can be combined with other neuromodulation techniques to enhance effectiveness, and it offers a non-invasive option that can modulate both brain and spinal cord activity. ^{1 3 9 10 11}

Eligibility Criteria

This trial is for males aged 18-45 with spinal cord injury (SCI) at least one year post-injury, who have complete motor SCI (ASIA A or B), and need catheterization for bladder control. Participants must be able to attend sessions twice a week for six months, have non-progressive SCI between C2-T8, and use their lower extremities for standing/stepping assistance.

Inclusion Criteria

I can stand and step using my legs.

My spinal cord injury is stable and located between my neck and mid-back.

I can attend testing sessions twice a week for 6 months.

Exclusion Criteria

I have had botox injections or bladder surgery.

I do not have any unhealed bone fractures, muscle issues, pressure sores, or active infections.

I have an enlarged prostate or bladder outlet issue.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive spinal cord neuromodulation through transcutaneous electrical stimulation and/or magnetic stimulation

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Electromagnetic Neuromodulation

Trial Overview The trial is testing the safety and effectiveness of electromagnetic neuromodulation in improving urinary bladder function among individuals with spinal cord injuries.

Participant Groups

Group I: Stimulation of Non-Naive Experimental Treatment 1 Intervention

Evaluate neuromodulation in 6 subjects with prior motor training.

Group II: Stimulation of Naive Experimental Treatment 1 Intervention

Evaluate neuromodulation in 6 naive subjects.

Group III: Stimulation Experimental Treatment 1 Intervention

Apply parameters discovered in Arm 1 and Arm 2 to evaluate neuromodulation in 12 naive subjects.

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Findings from Research

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]

New techniques like pharmacological neuromodulation and epidural stimulation, combined with motor training, are showing promise in recovering motor function after severe spinal cord injuries, which was previously thought impossible.

These methods can enhance the excitability of spinal cord circuits, allowing even individuals with complete paralysis to regain some voluntary control of movement, suggesting a significant advancement in rehabilitation strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new age for rehabilitation. Edgerton, VR., Roy, RR.[2012]

Combining epidural stimulation (ES) with deep brain stimulation (DBS) shows promise in enhancing movement recovery after spinal cord injury (SCI), as it targets both spinal and brain circuits to improve motor function.

Recent studies suggest that DBS of the mesencephalic locomotor region could significantly boost the effectiveness of neuromodulation therapies, indicating a potential new clinical approach for restoring locomotion in individuals with severe SCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined neuromodulatory approaches in the central nervous system for treatment of spinal cord injury. Noga, BR., Guest, JD.[2023]

Spinal cord stimulation (SCS) is evolving from a treatment for intractable pain to a potential method for restoring function after spinal cord injuries, driven by advances in understanding spinal cord lesions and compensatory mechanisms.

New SCS strategies, like spatiotemporal neuromodulation, show promise but require intensive rehabilitation techniques to be effective, highlighting the need for well-designed clinical trials to evaluate safety and efficacy in real-world applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in Spinal Cord Neuromodulation: The Integration of Neuroengineering, Computational Approaches, and Innovative Conceptual Frameworks. Pradat, PF., Hayon, D., Blancho, S., et al.[2023]

In a study involving 8 chronic cervical spinal cord injury patients, non-invasive transcutaneous stimulation combined with training led to a remarkable increase in maximum voluntary hand grip strength by approximately 325% during stimulation and 225% without it after 4 weeks of treatment.

The neuromodulation technique used does not directly induce muscle contractions but enables voluntary control, and some patients also experienced improvements in autonomic function and sensation below the injury site, suggesting broader benefits beyond just hand function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-Invasive Activation of Cervical Spinal Networks after Severe Paralysis. Gad, P., Lee, S., Terrafranca, N., et al.[2019]

Magnetic resonance imaging (MRI) can be safely performed on patients with spinal cord stimulator (SCS) implants, but safety recommendations vary by device model, and it is crucial to ensure the system is intact before the procedure to prevent patient injury.

Electrocautery is generally not recommended for patients with SCS due to risks of thermal injury, but if necessary, bipolar electrocautery is preferred over monopolar, and caution is advised to avoid complications, especially if there are concerns about the integrity of the SCS system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation: a review of the safety literature and proposal for perioperative evaluation and management. Walsh, KM., Machado, AG., Krishnaney, AA.[2018]

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 stimulation is a safe and reversible treatment option for pain management, making it a preferred choice when less invasive treatments are ineffective.

This method has no reported long-term side effects, highlighting its suitability as a first-line therapy for patients with chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation: patient selection, technique, and outcomes. Oakley, JC.[2019]

Noninvasive electrical and magnetic trans-spinal stimulation techniques can effectively reduce spinal reflex excitability, which may help treat conditions like hypertonia in patients with upper motor neuron lesions.

Transcutaneous spinal direct current stimulation shows potential for inducing long-lasting neuroplastic changes and may be beneficial in neurorehabilitation for spinal cord disorders, although more rigorous studies are needed to confirm these effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noninvasive Spinal Cord Stimulation: Technical Aspects and Therapeutic Applications. Nardone, R., Höller, Y., Taylor, A., et al.[2022]

Electrochemical neuromodulation therapies and robot-assisted rehabilitation have shown promise in restoring voluntary leg movements in chronic paraplegic individuals, indicating potential for improving mobility after spinal cord injuries.

In rodent models, these therapies led to significant remodeling of neural pathways, suggesting that similar mechanisms may be effective in humans, although challenges remain in translating these findings into widespread clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuroprosthetic technologies to augment the impact of neurorehabilitation after spinal cord injury. van den Brand, R., Mignardot, JB., von Zitzewitz, J., et al.[2018]

Neuromodulation techniques, such as electrical stimulation, have shown promise in treating various neurological disorders, including spinal cord injuries, by assisting with basic functions and potentially restoring movement.

Challenges like device durability, cost, and a limited understanding of mechanisms hinder broader clinical use, but ongoing technological advancements and research may lead to personalized treatments for spinal cord injury patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromodulation in the restoration of function after spinal cord injury. James, ND., McMahon, SB., Field-Fote, EC., et al.[2019]

References

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

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

2. Italy pubmed.ncbi.nlm.nih.gov

A new age for rehabilitation. [2012]

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

Combined neuromodulatory approaches in the central nervous system for treatment of spinal cord injury. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Advances in Spinal Cord Neuromodulation: The Integration of Neuroengineering, Computational Approaches, and Innovative Conceptual Frameworks. [2023]

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

Non-Invasive Activation of Cervical Spinal Networks after Severe Paralysis. [2019]

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

Spinal cord stimulation: a review of the safety literature and proposal for perioperative evaluation and management. [2018]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Off-Label Magnetic Resonance Imaging (MRI) in Patients with Persistent Pain with Spinal Cord Stimulators: A Case Series. [2022]

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

Spinal cord stimulation: patient selection, technique, and outcomes. [2019]

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

Noninvasive Spinal Cord Stimulation: Technical Aspects and Therapeutic Applications. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Neuroprosthetic technologies to augment the impact of neurorehabilitation after spinal cord injury. [2018]

11. England pubmed.ncbi.nlm.nih.gov

Neuromodulation in the restoration of function after spinal cord injury. [2019]