What side effects are associated with this type of intervention?

Common treatments for Spinal Cord Injury (SCI) such as Motor Skill Training (MST) and Transcutaneous Spinal Stimulation (TSS) have some known side effects. MST can lead to muscle fatigue, soreness, and overuse injuries due to extensive rehabilitation training. TSS may cause mild adverse events including a warm sensation, numbness, redness, itching, tingling, muscle spasms, and localized pain. Serious adverse events are rare for both treatments.

What prior FDA approvals exist?

There are no specific FDA-approved treatments for Spinal Cord Injury (SCI) that directly match the combination of Motor Skill Training (MST) and Transcutaneous Spinal Stimulation (TSS) as described. However, non-invasive spinal stimulation techniques, such as transcutaneous electrical nerve stimulation (TENS) and transcranial magnetic stimulation (TMS), have been approved for other conditions like chronic pain and migraines, which involve similar principles of electrical stimulation to enhance neural communication and function.

What other types of research exist?

Promising novel alternatives for SCI patients include: 1) Transcranial Magnetic Stimulation (TMS), which uses magnetic fields to stimulate nerve cells in the brain and has shown potential in improving motor function. 2) Transcutaneous Electrical Nerve Stimulation (TENS), which can help manage pain and improve muscle function through electrical stimulation. 3) Virtual Reality (VR)-based rehabilitation, which provides immersive environments for motor skill training and has shown promise in enhancing motor recovery. 4) Exoskeleton-assisted walking, which uses wearable robotic devices to aid in walking and improve mobility.

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TSS + MST for Spinal Cord Injury

N/A

Recruiting

Led By Edelle C Field-Fote, PT, PhD

Research Sponsored by Shepherd Center, Atlanta GA

Eligibility Criteria Checklist

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

Must have

Be 18-70 years of age

Able to move each leg independently for at least 3 steps (with or without the aid of an assistive device)

Must not have

Injuries below the neurological spinal level of T12

History of cardiovascular irregularities

Timeline

Screening 3 weeks

Treatment Varies

Follow Up testing 1(day 1), testing 2 (day 12), training 1-6 (days 15, 17, 19, 22, 24, 26), testing 3 (day 27)

Summary

This trial aims to help people with spinal cord injuries improve their walking ability. It combines movement exercises with a non-invasive method that uses mild electrical currents on the skin to boost communication between the brain and spinal cord. The goal is to see if this combined approach works better than exercises alone.

Who is the study for?

This trial is for adults aged 18-70 with spinal cord injuries at levels C3-T12, who can independently move each leg and stand with assistance. They must be stable on spasticity medications for at least two weeks and not have progressive spine disorders, implanted stimulators, skin issues near the stimulation site, cardiovascular irregularities, or cancer.

What is being tested?

The study tests if motor skill training (MST) improves walking in people with spinal cord injury and whether adding transcutaneous spinal stimulation (TSS) leads to greater improvements. Participants will receive MST alone or combined with TSS to see which method better enhances walking ability.

What are the potential side effects?

Potential side effects of TSS may include discomfort or skin irritation where the device attaches. MST could lead to muscle soreness or fatigue due to physical activity involved in the training.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 70 years old.

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I can walk at least 3 steps on my own, with or without help from a device.

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I can stand up with some help from one person.

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My spinal cord injury is classified as moderate to severe.

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I can stand for at least 5 minutes, with or without help.

Exclusion Criteria

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

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My injury is below the T12 spinal level.

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I have a history of heart problems.

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I have cuts or skin sensitivity where I might receive treatment.

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I have worsening spine or spinal cord conditions.

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I have cancer or had it in the past.

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I have a bone or joint problem that could affect my ability to exercise.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ testing 1(day 1), testing 2 (day 12), training 1-6 (days 15, 17, 19, 22, 24, 26), testing 3 (day 27)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~testing 1(day 1), testing 2 (day 12), training 1-6 (days 15, 17, 19, 22, 24, 26), testing 3 (day 27)

This trial's timeline: 3 weeks for screening, Varies for treatment, and testing 1(day 1), testing 2 (day 12), training 1-6 (days 15, 17, 19, 22, 24, 26), testing 3 (day 27) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in 10 Meter Walk Test

Secondary study objectives

Change of 2 Minute Walk Test

Change of Berg Balance Scale

Change of Falls Efficacy Scale-International Version (FES-I)

+8 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: MST + TSSExperimental Treatment2 Interventions

Individuals will participate in 6 training sessions of MST combined with TSS.

Group II: MST + ShamTSSPlacebo Group1 Intervention

Individuals will participate in 6 training sessions of MST while receiving shamTSS.

0 / 11Eligibility 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

Motor Skill Training (MST) enhances motor control and function through repetitive practice, which helps reorganize and strengthen neural pathways. Transcutaneous Spinal Stimulation (TSS) uses electrical stimulation to improve communication between the brain and spinal cord, potentially enhancing the effectiveness of motor commands. These treatments are significant for Spinal Cord Injury (SCI) patients as they offer non-invasive methods to improve walking, balance, strength, and reduce spasticity, thereby enhancing their overall quality of life.

Restoring walking after spinal cord injury: operant conditioning of spinal reflexes can help.