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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment using electromagnetic signals (electromagnetic neuromodulation) to help people with spinal cord injuries improve bladder function. Researchers will divide participants into groups to assess the treatment's effectiveness for those who have undergone motor training and those who have not. Men aged 18-45 who have had a spinal cord injury for at least a year and require catheter use may qualify if they can attend sessions twice a week for six months. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance quality of life for many.

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 neuromodulation technique is safe for improving urinary bladder function in spinal cord injury patients?

Research has shown that treatments involving spinal cord neuromodulation, such as electromagnetic methods, have been safe in past studies. For instance, one study found that non-invasive electrical stimulation of the spinal cord improved arm and hand functions in individuals with neck spinal cord injuries, without major side effects.

Additionally, reviews of spinal cord stimulation techniques generally support their safe use in patients. This suggests that neuromodulation is usually well-tolerated and safe. However, individual experiences can vary, so discussing any concerns with a healthcare provider is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about electromagnetic neuromodulation for spinal cord injury because it offers a novel approach to enhancing motor function. Unlike traditional therapies, which often rely on physical rehabilitation and surgery, this treatment uses electromagnetic waves to stimulate nerve activity. This method holds promise for reactivating neural pathways that are otherwise dormant, potentially offering improved outcomes for individuals with spinal cord injuries. The excitement also stems from its non-invasive nature, which could lead to fewer complications and a quicker recovery compared to more invasive procedures.

What evidence suggests that electromagnetic neuromodulation is effective for improving urinary bladder function in spinal cord injury?

Research has shown that electromagnetic techniques to stimulate nerves can help people with spinal cord injuries (SCI) improve their abilities. In this trial, participants will be divided into different arms to evaluate the effects of neuromodulation. One study examined new spinal cord stimulation methods and found they could aid recovery without causing serious side effects. Another study focused on ARC EX Therapy, which improved hand and arm movement in people with neck-related SCI. Early tests of magnetic field therapy (MFT) also showed promising results for SCI recovery. These findings suggest that nerve stimulation could help people with SCI regain some lost functions, such as bladder control. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12178020/

Neuromodulation techniques for the treatment of spinal cord ... This study aims to comprehensively review the latest research advancements in spinal cord injury neurostimulation technologies, explore their practical ...

2. nature.com nature.com/articles/s41591-024-02940-9

Non-invasive spinal cord electrical stimulation for arm and ... These results demonstrate the safety and efficacy of ARC EX Therapy to improve hand and arm functions in people living with cervical SCI.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2324242625000270

Application and progress of magnetic field therapy for ... Collectively, these preliminary clinical trial results suggest that MFT may have positive effects on the recovery of SCI patients with no serious adverse events ...

4. e-neurospine.org e-neurospine.org/journal/view.php?doi=10.14245/ns.2244652.326

A Review of Functional Restoration From Spinal Cord ... This review aims to assess the efficacy of spinal cord stimulation, both epidural (eSCS) and transcutaneous (tSCS), on the return of function in individuals ...

5. josr-online.biomedcentral.com josr-online.biomedcentral.com/articles/10.1186/s13018-025-05674-7

Global trends and hotspots of neuromodulation in spinal cord ... The present study systematically collected and analyzed the relevant literature on neuromodulation in the context of SCI. The findings indicate ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0003999322001241

Spinal Cord Stimulators: Patient Safety and Adverse ... Main Outcome Measures. Is the usage of MRI safe in patients with spinal cord stimulators (SCS)?. Results. The current recommendations, composed on ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9700088/

study protocol for a prospective, randomized, controlled trial This trial will collect data regarding the therapeutic effects of EMG-induced rehabilitation in patients with SCI receiving epidural electrical stimulation for ...