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Acoustic Stimuli for Spinal Cord Injury

N/A
Waitlist Available
Research Sponsored by Shirley Ryan AbilityLab
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)
Must not have
History of head injury or stroke
Ongoing cord compression or a syrinx in the spinal cord or who suffer from a spinal cord disease such as spinal stenosis, spina bifida, or herniated cervical disk
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3-4 hours
Awards & highlights

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 below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a head injury or stroke in the past.
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I have a spinal condition like stenosis, spina bifida, or a herniated disk.
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I am taking medication that affects my brain and could make seizures more likely.
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I do not have unmanaged lung, heart, or bone problems.
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I had a condition before my spinal cord injury that made it hard for me to exercise.
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I have a history of seizures.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-4 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-4 hours for reporting.

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 more

Trial 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
200 Previous Clinical Trials
17,043 Total Patients Enrolled

Media Library

Acoustic stimuli (Startle) Clinical Trial Eligibility Overview. Trial Name: NCT04393922 — N/A
Spinal Cord Injury Research Study Groups: Aim 1, Aim 2
Spinal Cord Injury Clinical Trial 2023: Acoustic stimuli (Startle) Highlights & Side Effects. Trial Name: NCT04393922 — N/A
Acoustic stimuli (Startle) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04393922 — N/A
~23 spots leftby Jul 2025
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