UnknownNot Applicable

Spasticity and Functional Recovery After SCI

United States240 participantsStarted 2020-07-01

Plain-language summary

Spasticity is one of the most common symptoms manifested in humans with spinal cord injury (SCI). However, the neural mechanisms underlying the development of spasticity over time after an acute SCI are not yet understood. Using electrophysiological and imaging techniques along with traditional measurements of neurological recovery in the acute rehabilitation setting including physical exam and functional assessments; the investigators aim to examine the relationship between development of spasticity, residual descending motor pathways and functional and neurological recovery in humans with SCI from acute to subacute phase

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. Male and females 18 years of age or greater
. Basic proficiency in English language communication
. Under 18 years of age
. Uncontrolled medical problems including pulmonary, cardiovascular, or orthopedic disease
. History of neurological impairment or conditions affecting the Central Nervous System
. Premorbid, ongoing major depression or psychosis, altered cognitive status
. Pregnancy

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Modified Ashworth scale (MAS)

Timeframe: From the time of admission to the hospital and enrolled in the study till the time of discharge (up to 12 weeks)

Motor evoked potential (MEP)

Timeframe: From the time of admission to the hospital and enrolled in the study till the time of discharge (up to 12 weeks)

First swing test (FST)

Timeframe: From the time of admission to the hospital and enrolled in the study till the time of the discharge (up to 12 weeks)

Trial details

NCT IDNCT06030531

SponsorShirley Ryan AbilityLab

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-12-31

View on ClinicalTrials.gov More Acute Spinal Cord Injury trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. Male and females 18 years of age or greater
. Basic proficiency in English language communication
. Under 18 years of age
. Uncontrolled medical problems including pulmonary, cardiovascular, or orthopedic disease
. History of neurological impairment or conditions affecting the Central Nervous System
. Premorbid, ongoing major depression or psychosis, altered cognitive status
. Pregnancy

What they're measuring

Modified Ashworth scale (MAS)

Timeframe: From the time of admission to the hospital and enrolled in the study till the time of discharge (up to 12 weeks)

Motor evoked potential (MEP)

Timeframe: From the time of admission to the hospital and enrolled in the study till the time of discharge (up to 12 weeks)

First swing test (FST)

Timeframe: From the time of admission to the hospital and enrolled in the study till the time of the discharge (up to 12 weeks)