What side effects are associated with this type of intervention?

Common treatments for spinal cord injury similar to transcutaneous spinal electrical stimulation (TSES) include transcutaneous electrical nerve stimulation (TENS) and spinal cord stimulation (SCS). Known side effects of these treatments can include mild device-associated adverse events such as a warm sensation, numbness, redness, itching, tingling, muscle spasms, and localized pain in areas like the arm, shoulder, or neck. Serious adverse events are rare, but patients should be monitored for any unusual symptoms.

What prior FDA approvals exist?

Currently, there are no specific FDA-approved treatments for spinal cord injury that directly align with transcutaneous spinal electrical stimulation (TSES). However, various neuromodulation techniques, such as transcutaneous electrical nerve stimulation (TENS) and spinal cord stimulation (SCS), have been explored for pain management and functional improvement in SCI patients. These methods involve delivering electrical currents through the skin or directly to the spinal cord to modulate neural activity and alleviate symptoms. While TSES is still under investigation, these related neuromodulation techniques provide a foundation for its potential therapeutic use.

What other types of research exist?

Promising, novel alternatives to Transcutaneous Spinal Electrical Stimulation for Spinal Cord Injury patients include: 1) Remote Electrical Neuromodulation, which has shown efficacy in pain relief and is approved for use in the United States. 2) Transcranial Magnetic Stimulation (TMS), which has demonstrated effectiveness in pain management and migraine treatment, and may be useful for patients who do not respond to first-line therapies. 3) Noninvasive Vagus Nerve Stimulation (nVNS), which has potential benefits for various neurological conditions and could be explored for SCI treatment.

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Neuromodulation

Spinal Stimulation for Spinal Cord Injury

N/A

Recruiting

Research Sponsored by University of Manitoba

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with spinal cord injury from C4 to L4

Be older than 18 years old

Must not have

History of seizures

Timeline

Screening 3 weeks

Treatment Varies

Follow Up immediately after stimulation (within 1-15 min)

Summary

This trial is testing a method where small electrical currents are applied through the skin to stimulate the spinal cord. It aims to help people with spinal cord injuries improve their ability to move. The electrical signals may enhance communication between the brain and muscles, leading to better motor function. This technique has been explored for various applications, including pain control and muscle stimulation, and is now being tested for improving motor function in spinal cord injury patients.

Who is the study for?

This trial is for up to 24 people living with spinal cord injury (SCI), specifically those with paraplegia. The study aims to include individuals who can safely undergo various spinal stimulation protocols.

What is being tested?

The study tests transcutaneous spinal electrical stimulation methods in SCI patients. It compares the effects of different stimulations: EPS, DCS, and sham versions where no actual stimulation is given.

What are the potential side effects?

Potential side effects are not detailed here but may include discomfort at the stimulation site, muscle spasms, or skin irritation due to the electrical nature of the treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My spinal cord injury is between my neck and lower back.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a history of seizures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and during procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Motor evoked potentials

Motor response

Secondary study objectives

Blood pressure

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Spinal cord stimulationExperimental Treatment2 Interventions

Spinal cord stimulation will be administered to participants for 15 min.

Group II: Shamspinal cord stimulationPlacebo Group2 Interventions

Sham spinal cord stimulation will be administered to participants for 15 min.

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Transcutaneous Spinal Electrical Stimulation (TSES) involves delivering electrical currents through the skin to stimulate the spinal cord. This stimulation can enhance neural plasticity, improve motor function, and potentially restore some degree of voluntary movement by activating dormant neural pathways. Understanding these mechanisms is crucial for SCI patients as it offers a non-invasive option that can complement other rehabilitative therapies, potentially leading to improved outcomes in mobility and quality of life.