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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

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3-4 hours

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

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

Primary study objectives

10-meter walk test

Graded and Redefined Assessment of Strength, Sensibility and Prehension (GRASSP).

Ipsilateral MEPs (iMEPs)

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 9Eligibility criteria met