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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Ages 18-75 years
Chronic SCI (≥1 year of injury)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3-4 hours
Awards & highlights
Study Summary
This trial will help researchers understand how the body changes neurologically after a Spinal Cord Injury, which will in turn help patients with SCIs learn to live with their injury.
Who is the study for?
This trial is for adults aged 18-75 with chronic incomplete spinal cord injury at T12 or above, who've had the injury for over a year. Participants should be able to move their elbow, knee, or ankle voluntarily and grasp objects. It's not suitable for those with uncontrolled medical issues, major depression/psychosis before SCI, history of head injury/stroke/seizures, metal in the skull, pacemaker users, pregnant women or people on certain CNS drugs.Check my eligibility
What is being tested?
The study investigates how acoustic stimuli (Startle) can affect muscle stiffness (spasticity) after spinal cord injuries (SCI). The goal is to understand neurological recovery post-SCI and improve arm/hand function hindered by spasticity.See study design
What are the potential side effects?
Since this trial involves non-invasive acoustic stimuli rather than medication or surgery, significant side effects are not anticipated. However, participants may experience discomfort from startle responses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 75 years old.
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I have had a spinal cord injury for at least one year.
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I have a partial spinal cord injury above my waist.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3-4 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-4 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
10-meter walk test
Graded and Redefined Assessment of Strength, Sensibility and Prehension (GRASSP).
Ipsilateral MEPs (iMEPs)
+7 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Aim 2Experimental Treatment1 Intervention
To accomplish this aim, we will use a randomized crossover design study with spastic SCI participants receiving a single intervention combining non-invasive acoustic stimuli (Startle) or sham-Startle with motor training to enhance cortico- and reticulo-spinal contribution, separated by ~2 weeks.
Visit 1 and Visit 2
Single intervention of:
Startle + exercise training OR sham-Startle + exercise training
Pre and post measurements:
MVCs
MEP recruitment curves
iMEPs
StartReact
Participant reported spasticity
MAS
PSAD
KINARM
Neuromechanical hand and/or leg testing
GRASSP
TRI-HFT
10-meter walk test
Pendulum Test
Group II: Aim 1Experimental Treatment1 Intervention
To accomplish this aim, we will conduct one experiment in two sessions separated by 2- 3 days using a crossover design. Participants will be assigned into one of three groups: spastic SCI, non-spastic SCI, and controls. We expect that people enrolled in Aim 1 will complete 2 visits within 1 week.
Visit 1 Measurements:
MVCs
MEP Recruitment Curves
iMEPs
StartReact
Visit 2 Measurements:
Participant Reported Spasticity
MAS
PSAD
KINARM
MRI of brain and spinal cord
Find a Location
Who is running the clinical trial?
Shirley Ryan AbilityLabLead Sponsor
193 Previous Clinical Trials
16,765 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a certain score on the MAS assessment.I have had a head injury or stroke in the past.I can bend and straighten my elbow, knee, or ankle on my own.You have a pacemaker.You have a history of severe depression or psychosis, or have problems with your memory and thinking.I am between 18 and 75 years old.I can reach for and grab things.I am either male or female.I have a spinal condition like stenosis, spina bifida, or a herniated disk.I have had a spinal cord injury for at least one year.You have a score of 0 or 1 on the Modified Ashworth Scale (MAS) if you have spinal cord injury and do not have muscle stiffness.You have a metal plate in your skull.I can bend and straighten my elbow, knee, or ankle.You use your right hand for activities.I am taking medication that affects my brain and could make seizures more likely.I have a partial spinal cord injury above my waist.I do not have unmanaged lung, heart, or bone problems.I had a condition before my spinal cord injury that made it hard for me to exercise.I have a history of seizures.
Research Study Groups:
This trial has the following groups:- Group 1: Aim 1
- Group 2: Aim 2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent is the sample size for this trial expanding?
"Indeed, according to clinicaltrials.gov this medical experiment is presently enrolling patients. This trial was posted on May 13th 2020 with its most recent update being June 20th 2022; 120 individuals are sought after at 1 site of the study."
Answered by AI
Is entry into this clinical trial restricted to individuals under twenty years old?
"This medical study only accepts participants aged 18 to 75. However, there are 157 trials for minors and 771 trials available for seniors."
Answered by AI
Is there still an opportunity for participants to join this research project?
"According to the database hosted on clinicaltrials.gov, this research project was initially posted in May of 2020 and since then has had edits made as recently as June 2022. At present, they are actively seeking participants."
Answered by AI
Could I partake in this scientific exploration if I meet the criteria?
"This clinical trial is enrolling 120 people aged 18-75 with spinal cord injuries, who meet the following requirements: An incomplete injury at T12 or higher on the American Spinal Injury Association Impairment Scale (AIS), AIS scores of 0 and 1 for spastic individuals, AIS scores 2, 3 and 4 for non-spastic individuals, The capacity to carry out voluntary flexion and extension of the elbow/knee/ankle."
Answered by AI
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