36 Participants Needed

Transspinal Stimulation for Spinal Cord Injury

MK
Overseen ByMARIA KNIKOU, PT, MBA, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Maria Knikou, PT, MBA, PhD
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 investigates a new method to help individuals with spinal cord injuries improve movement and essential body functions. The technique, called multisite transspinal stimulation, sends gentle electrical signals through the skin to the spinal cord. Some participants will receive this stimulation while resting, while others will receive it during robotic-aided walking exercises. Suitable candidates have had an incomplete spinal cord injury for more than six months and face challenges with standing, walking, or other body functions. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to innovative treatments for spinal cord injuries.

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 transspinal stimulation is safe for spinal cord injury patients?

A previous study tested the safety of multisite transspinal stimulation, which uses small electrical pulses on the skin to aid the spinal cord. Research has shown that this method is generally well-tolerated, with most people experiencing only a tingling sensation. Some studies noted minor discomfort, but serious side effects were rare. Additional animal research demonstrated that repeated sessions can reduce symptoms like muscle stiffness. As a non-invasive technique, it carries a low risk profile and shows promise for people with spinal cord injuries seeking to improve walking and other functions.12345

Why are researchers excited about this trial?

Researchers are excited about multisite transspinal stimulation for spinal cord injury because it offers a non-invasive way to potentially enhance neural recovery and motor function. Unlike traditional rehabilitation methods, this approach uses electrical stimulation at specific spinal sites to activate neural pathways, which might improve outcomes without the need for surgery or medication. Additionally, when combined with robotic gait training, it could further enhance motor recovery by synchronizing stimulation with movement, offering a novel synergy not present in standard therapies.

What evidence suggests that multisite transspinal stimulation could be effective for spinal cord injury?

This trial will evaluate multisite transspinal stimulation for individuals with spinal cord injuries (SCI). Studies have shown that transspinal stimulation, which sends signals to the spinal cord through the skin, can help people with long-term SCI improve their abilities. In this trial, participants will receive multisite transspinal stimulation either at rest or during robotic gait training. Research indicates that combining this stimulation with activity-based exercises, like step training, has helped patients regain some functions. Specifically, improvements have been seen in standing, walking, and important functions like bladder and bowel control. The stimulation enhances communication between the spinal cord, brain, and muscles. This method is promising because it is non-invasive, requiring no surgery, and can be used alongside other treatments to boost recovery.12678

Who Is on the Research Team?

MK

MARIA KNIKOU, PT, MBA, PhD

Principal Investigator

City University of New York, College of Staten Island

Are You a Good Fit for This Trial?

This trial is for individuals with incomplete spinal cord injury (SCI) who are looking to improve their standing, walking, and vital body functions. The study aims to develop a non-invasive treatment that can be used globally in various clinical settings.

Inclusion Criteria

Willingness to comply with all study procedures and availability for the duration of the study
Ability to understand the consent form and sign the consent form
In good general health as evidenced by medical history
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Exclusion Criteria

I have a severe urinary tract infection.
Participation in an ongoing research study or new rehabilitation program
Pregnant women or women who suspect they may be or may become pregnant will be excluded from participation because the risks of thoracolumbar stimulation to the fetus are unknown
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive cervical and lumbosacral transspinal stimulation, either at rest or during robotic gait training, for 20 sessions over 4 weeks

4 weeks
20 sessions (in-person)

Follow-up

Participants are monitored for changes in neurophysiological biomarkers and functional outcomes such as walking, bladder, bowel, and sexual function

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Multisite Transspinal Stimulation
Trial Overview The trial tests the effects of multisite transspinal stimulation both at rest and during robotic gait training. It combines cervical and lumbosacral stimulation with locomotor training to potentially enhance recovery after SCI.
How Is the Trial Designed?
2Treatment groups
Active Control
Group I: Multisite transspinal stimulation at restActive Control1 Intervention
Group II: Multisite transspinal stimulation during robotic gait trainingActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Maria Knikou, PT, MBA, PhD

Lead Sponsor

Citations

Safety and Effectiveness of Multisite Transcutaneous ...Combined tSCS + ABT facilitated functional recovery after chronic SCI. Improvements required ≥60 tSCS-ABT sessions, with further exposure to tSCS facilitating ...
Multisite Transspinal Stimulation for Augmenting Recovery ...Study Overview. Brief Summary. A well-established rehabilitation strategy for improvements of standing and walking ability in persons with spinal cord injury ( ...
3.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/39998450
Safety and Effectiveness of Multisite Transcutaneous ...Combined tSCS + ABT facilitated functional recovery after chronic SCI. Improvements required ≥60 tSCS-ABT sessions, with further exposure to tSCS facilitating ...
Effectiveness of Transcutaneous Spinal Cord Stimulation ...Objective: This systematic review and meta-analysis will determine the effectiveness of tSCS, compared with sham stimulation, no intervention, ...
Multisite Transspinal Stimulation for Augmenting Recovery ...A promising intervention is stimulation of the spinal cord through the skin (transspinal). No single intervention is likely to significantly improve long-term ...
Multi-session transcutaneous spinal cord stimulation ...Here, we show that multi-session tSCS in rats with an incomplete (severe T9 contusion) SCI (1) decreases hyperreflexia, (2) increases the low ...
Optimizing Transcutaneous Spinal Cord StimulationTranscutaneous spinal cord stimulation (tSCS) is a non-invasive technique designed to enhance motor function in individuals living with spinal cord injury (SCI) ...
Modulations in neural pathways excitability post ...Transcutaneous spinal cord stimulation (TSCS), a non-invasive form of spinal cord stimulation, has been shown to improve motor function in ...
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