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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 belowSelect...
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:Select...
My injury is below the T12 spinal level.
Select...
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)
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 moreTrial 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.
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.
Restoring walking after spinal cord injury: operant conditioning of spinal reflexes can help.
Find a Location
Who is running the clinical trial?
Shepherd Center, Atlanta GALead Sponsor
29 Previous Clinical Trials
3,983 Total Patients Enrolled
National Institute on Disability, Independent Living, and Rehabilitation ResearchFED
79 Previous Clinical Trials
9,819 Total Patients Enrolled
Edelle C Field-Fote, PT, PhDPrincipal InvestigatorShepherd Center, Atlanta GA
6 Previous Clinical Trials
287 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can walk at least 3 steps on my own, with or without help from a device.I can follow instructions and tell someone if I'm in pain.I am between 18 and 70 years old.I can stand up with some help from one person.I am on stable medication for spasticity and will inform the study if my medication changes.I have had a spinal cord injury between my neck and mid-back for over 3 months.My spinal cord injury is classified as moderate to severe.My injury is below the T12 spinal level.I can stand for at least 5 minutes, with or without help.I have a history of heart problems.If you have any implanted devices that use electrical stimulation, you cannot participate in the study because we are not sure how these devices might interact with the treatment.I have cuts or skin sensitivity where I might receive treatment.I have worsening spine or spinal cord conditions.I have cancer or had it in the past.I have a bone or joint problem that could affect my ability to exercise.
Research Study Groups:
This trial has the following groups:- Group 1: MST + TSS
- Group 2: MST + ShamTSS
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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