24 Participants Needed

Neuromodulation for Spinal Cord Injury

DL
Overseen ByDaniel Lu, MD PhD
Age: 18 - 65
Sex: Male
Trial Phase: Academic
Sponsor: University of California, Los Angeles
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

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.12345

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.14678

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.1491011

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.
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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.
See 4 more

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?
3Treatment groups
Experimental Treatment
Group I: Stimulation of Non-NaiveExperimental Treatment1 Intervention
Group II: Stimulation of NaiveExperimental Treatment1 Intervention
Group III: StimulationExperimental Treatment1 Intervention

Find a Clinic Near You

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

Citations

Historical development and contemporary use of neuromodulation in human spinal cord injury. [2023]
A new age for rehabilitation. [2012]
Combined neuromodulatory approaches in the central nervous system for treatment of spinal cord injury. [2023]
Advances in Spinal Cord Neuromodulation: The Integration of Neuroengineering, Computational Approaches, and Innovative Conceptual Frameworks. [2023]
Non-Invasive Activation of Cervical Spinal Networks after Severe Paralysis. [2019]
Spinal cord stimulation: a review of the safety literature and proposal for perioperative evaluation and management. [2018]
Off-Label Magnetic Resonance Imaging (MRI) in Patients with Persistent Pain with Spinal Cord Stimulators: A Case Series. [2022]
Spinal cord stimulation: patient selection, technique, and outcomes. [2019]
Noninvasive Spinal Cord Stimulation: Technical Aspects and Therapeutic Applications. [2022]
Neuroprosthetic technologies to augment the impact of neurorehabilitation after spinal cord injury. [2018]
Neuromodulation in the restoration of function after spinal cord injury. [2019]
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